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Sample records for pharmaceutical approval update

  1. Pharmaceutical Approval Update.

    PubMed

    Gohil, Kunj

    2015-09-01

    Sacubitril/valsartan (Entresto) for chronic heart failure; brexpiprazole (Rexulti) for major depressive disorder and schizophrenia; and lumacaftor/ivacaftor (Orkambi) for cystic fibrosis involving specific CFTR mutations. PMID:26417173

  2. Pharmaceutical Approval Update.

    PubMed

    Kaufman, Michele B

    2016-08-01

    Venetoclax (Venclexta) for chronic lymphocytic leukemia; riboflavin 5'-phosphate solutions (Photrexa Viscous and Photrexa) for progressive keratoconus; and pimavanserin (Nuplazid) for Parkinson's disease psychosis. PMID:27504063

  3. Pharmaceutical Approval Update.

    PubMed

    Gohil, Kunj

    2015-10-01

    Alirocumab (Praluent) for high cholesterol; flibanserin (Addyi) for sexual desire disorder in women; daclatasvir (Daklinza) for chronic hepatitis C virus (HCV) genotype 3 infection; and ombitasvir/paritaprevir/ritonavir (Technivie) for genotype 4 HCV infection without cirrhosis. PMID:26535020

  4. Pharmaceutical approval update.

    PubMed

    Goldenberg, Marvin M

    2013-09-01

    Afatinib (Gilotrif) for non-small-cell lung cancer; golimumab (Simponi Aria) for moderate-to-severe active rheumatoid arthritis; and levomilnacipran (Fetzima) extended release for major depressive disorder. PMID:24273397

  5. Pharmaceutical approval update.

    PubMed

    Gohil, Kunj

    2014-12-01

    Ledipasvir/sofosbuvir (Harvoni) for hepatitis C virus genotype 1 infection; dulaglutide (Trulicity) for glycemic control in type-2 diabetes; netupitant/palonosetron (Akynzeo) for prevention of nausea and vomiting related to chemotherapy; and naloxegol (Movantik) for opioid-induced constipation in patients with chronic noncancer pain.

  6. Pharmaceutical approval update.

    PubMed

    Gohil, Kunj

    2015-02-01

    Blinatumomab (Blincyto) for acute lymphoblastic leukemia; human papillomavirus 9-valent vaccine, recombinant (Gardasil 9) for extended protection against cervical cancer; and hydrocodone bitartrate extended release (Hysingla ER) for 24-hour management of severe pain. PMID:25673958

  7. An updated review of long-term outcomes from randomized controlled trials in approved pharmaceuticals for diabetic macular edema.

    PubMed

    Wang, Jia-Kang; Huang, Tzu-Lun; Su, Pei-Yuan; Chang, Pei-Yao

    2015-12-01

    Diabetic macular edema (DME) is a major sight-threatening cause in diabetic patients. We review the long-term outcome of four approved pharmacotherapy for treating DME, including intravitreal injections of corticosteroids (dexamethasone implants and fluocinolone acetonide inserts) and anti-vascular endothelial growth factor (VEGF) (ranibizumab and aflibercept). They all show superior ability to improve vision and reduce macular thickness, comparing with sham injections or macular focal/grid laser treatment. Anti-VEGF agents result in low incidence of severe ocular or systemic adverse effects, but glaucoma and cataract should be aware after intravitreal corticosteroids. Prompt treatment with these agents can lead to a better outcome PMID:27215008

  8. Drug updates and approvals: 2015 in review.

    PubMed

    Klibanov, Olga M; Phan, Diep; Ferguson, Kelli

    2015-12-12

    This article highlights important prescribing information for some drugs that received FDA approval within the past year. These include: atazanavir and cobicistat (Evotaz®), ceftazidime and avibactam (Avycaz®), edoxaban (Savaysa®), ivabradine (Corlanor®), liraglutide (rDNA origin) injection (Saxenda®), perindopril arginine and amlodipine besylate (Prestalia®), and secukinumab (Cosentyx®) subcutaneous injection. PMID:26545091

  9. 75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-24

    ... URBAN DEVELOPMENT FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA...) Annual renewal of each FHA lender's approval, (3) Updates to a FHA lender's approval and (4) Various... CONTACT: Leroy McKinney, Jr., Reports Management Officer, QDAM, Department of Housing and...

  10. 78 FR 32367 - Approval of Subzone Status; Teva Pharmaceuticals USA, Inc.; North Wales, Chalfont, Kutztown and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-30

    ... Federal Register inviting public comment (78 FR 17634-17635, 3-22-2013). The FTZ staff examiner reviewed... Foreign-Trade Zones Board Approval of Subzone Status; Teva Pharmaceuticals USA, Inc.; North Wales... of Teva Pharmaceuticals USA, Inc., in North Wales, Chalfont, Kutztown and Sellersville,...

  11. Hepatitis treatment update: new approvals, not much news.

    PubMed

    Learned, J

    Thymosin-Alpha-1 (Zadaxin) is a synthetic hormone that has been studied as a treatment for HIV, hepatitis B, and hepatitis C. Recently approved in Mexico as a booster for the flu vaccine, it was also approved in nine other countries for flu, hepatitis B, and hepatitis C. The demand for Thymosin is great but it is difficult to procure. A partnership between Schering-Plough and SciClone Pharmaceuticals has renewed hope that the demand for Thymosin will be met. Schering-Plough is also marketing Rebetron, a packaged combination of Ribavirin capsules and injectable alpha-interferon (Intron-A), for the treatment of hepatitis C. Other hepatitis treatments are described, such as Epivir-HBV (3TC, Epivir) which was approved in December for the treatment of Hepatitis B. Epivir-HBV has shown promising results. PMID:11366197

  12. Three Newly Approved Analgesics: An Update

    PubMed Central

    Saraghi, Mana; Hersh, Elliot V.

    2013-01-01

    Since 2008, three new analgesic entities, tapentadol immediate release (Nucynta) diclofenac potassium soft gelatin capsules (Zipsor), and bupivacaine liposome injectable suspension (EXPAREL) were granted US Food and Drug Administration (FDA) approval to treat acute pain. Tapentadol immediate-release is a both a mu-opioid agonist and a norepinephrine reuptake inhibitor, and is indicated for the treatment of moderate to severe pain. Diclofenac potassium soft gelatin capsules are a novel formulation of diclofenac potassium, which is a nonsteroidal anti-inflammatory drug (NSAID), and its putative mechanism of action is through inhibition of cyclooxygenase enzymes. This novel formulation of diclofenac allows for improved absorption at lower doses. Liposomal bupivacaine is a new formulation of bupivacaine intended for single-dose infiltration at the surgical site for postoperative analgesia. Bupivacaine is slowly released from this liposomal vehicle and can provide prolonged analgesia at the surgical site. By utilizing NSAIDs and local anesthetics to decrease the transmission of afferent pain signals, less opioid analgesics are needed to achieve analgesia. Since drug-related adverse events are frequently dose related, lower doses from different drug classes may be employed to reduce the incidence of adverse effects, while producing synergistic analgesia as part of a multimodal analgesic approach to acute pain. PMID:24423420

  13. 76 FR 72955 - Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for MYLOTARG

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... HUMAN SERVICES Food and Drug Administration Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for MYLOTARG AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for...

  14. Recombinant pharmaceuticals from microbial cells: a 2015 update.

    PubMed

    Sanchez-Garcia, Laura; Martín, Lucas; Mangues, Ramon; Ferrer-Miralles, Neus; Vázquez, Esther; Villaverde, Antonio

    2016-01-01

    Diabetes, growth or clotting disorders are among the spectrum of human diseases related to protein absence or malfunction. Since these pathologies cannot be yet regularly treated by gene therapy, the administration of functional proteins produced ex vivo is required. As both protein extraction from natural producers and chemical synthesis undergo inherent constraints that limit regular large-scale production, recombinant DNA technologies have rapidly become a choice for therapeutic protein production. The spectrum of organisms exploited as recombinant cell factories has expanded from the early predominating Escherichia coli to alternative bacteria, yeasts, insect cells and especially mammalian cells, which benefit from metabolic and protein processing pathways similar to those in human cells. Up to date, around 650 protein drugs have been worldwide approved, among which about 400 are obtained by recombinant technologies. Other 1300 recombinant pharmaceuticals are under development, with a clear tendency towards engineered versions with improved performance and new functionalities regarding the conventional, plain protein species. This trend is exemplified by the examination of the contemporary protein-based drugs developed for cancer treatment. PMID:26861699

  15. Recombinant pharmaceuticals from microbial cells: a 2015 update.

    PubMed

    Sanchez-Garcia, Laura; Martín, Lucas; Mangues, Ramon; Ferrer-Miralles, Neus; Vázquez, Esther; Villaverde, Antonio

    2016-02-09

    Diabetes, growth or clotting disorders are among the spectrum of human diseases related to protein absence or malfunction. Since these pathologies cannot be yet regularly treated by gene therapy, the administration of functional proteins produced ex vivo is required. As both protein extraction from natural producers and chemical synthesis undergo inherent constraints that limit regular large-scale production, recombinant DNA technologies have rapidly become a choice for therapeutic protein production. The spectrum of organisms exploited as recombinant cell factories has expanded from the early predominating Escherichia coli to alternative bacteria, yeasts, insect cells and especially mammalian cells, which benefit from metabolic and protein processing pathways similar to those in human cells. Up to date, around 650 protein drugs have been worldwide approved, among which about 400 are obtained by recombinant technologies. Other 1300 recombinant pharmaceuticals are under development, with a clear tendency towards engineered versions with improved performance and new functionalities regarding the conventional, plain protein species. This trend is exemplified by the examination of the contemporary protein-based drugs developed for cancer treatment.

  16. Chitosan: An Update on Potential Biomedical and Pharmaceutical Applications

    PubMed Central

    Cheung, Randy Chi Fai; Ng, Tzi Bun; Wong, Jack Ho; Chan, Wai Yee

    2015-01-01

    Chitosan is a natural polycationic linear polysaccharide derived from chitin. The low solubility of chitosan in neutral and alkaline solution limits its application. Nevertheless, chemical modification into composites or hydrogels brings to it new functional properties for different applications. Chitosans are recognized as versatile biomaterials because of their non-toxicity, low allergenicity, biocompatibility and biodegradability. This review presents the recent research, trends and prospects in chitosan. Some special pharmaceutical and biomedical applications are also highlighted. PMID:26287217

  17. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    PubMed Central

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  18. Physicians and the pharmaceutical industry (update 1994). Canadian Medical Association.

    PubMed Central

    1994-01-01

    The history of health care delivery in Canada has been marked by close collaboration between physicians and the pharmaceutical and health supply industries, this collaboration extending to research as well as to education. Since medicine is a self-governing profession physicians have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their duties toward their patients and society. The following guidelines have been developed by the CMA to assist physicians in determining when a relationship with industry is appropriate. Although directed primarily to individual physicians, including residents and interns as well as medical students, the guidelines also govern the relationships between industry and medical associations. These guidelines focus on the pharmaceutical companies; however, the CMA considers that the same principles apply to the relationship between its members and manufacturers of medical devices, infant formulas and similar products, and health care products and service suppliers in general. These guidelines reflect a national consensus and are meant to serve as an educational resource for physicians throughout Canada. PMID:8287348

  19. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals

    PubMed Central

    Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

    2015-01-01

    Introduction Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Objectives Trends in FDA approved FDC in the period 1980–2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. Materials and Methods New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. Results During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. Conclusion FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination. PMID:26469277

  20. 77 FR 40367 - Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

    ... HUMAN SERVICES Food and Drug Administration Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA)...

  1. 76 FR 59144 - Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... HUMAN SERVICES Food and Drug Administration Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications; Correction AGENCY: Food and... document withdrew approval of 27 new drug applications (NDAs) and 58 abbreviated new drug...

  2. 77 FR 24723 - AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... HUMAN SERVICES Food and Drug Administration AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA)...

  3. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs.

    PubMed

    1997-02-01

    Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement recommending that the Food and Drug Administration mandate labeling of over-the-counter and prescription formulations to include a qualitative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reactions continue to be reported, although some are no longer considered clinically significant, and other new reactions have emerged. The original statement, therefore, has been updated and its information expanded.

  4. Savannah River Site Approved Site Treatment Plan, 1998 Annual Update

    SciTech Connect

    Lawrence, B.; Berry, M.

    1998-03-01

    The U.S. Department of Energy, Savannah River Operations Office (DOE- SR),has prepared the Site Treatment Plan (STP) for Savannah River Site (SRS) mixed wastes in accordance with RCRA Section 3021(b), and SCDHEC has approved the STP (except for certain offsite wastes) and issued an order enforcing the STP commitments in Volume I. DOE-SR and SCDHEC agree that this STP fulfills the requirements contained in the FFCAct, RCRA Section 3021, and therefore,pursuant to Section 105(a) of the FFCAct (RCRA Section 3021(b)(5)), DOE`s requirements are to implement the plan for the development of treatment capacities and technologies pursuant to RCRA Section 3021.Emerging and new technologies not yet considered may be identified to manage waste more safely, effectively, and at lower cost than technologies currently identified in the plan. DOE will continue to evaluate and develop technologies that offer potential advantages in public acceptance, privatization, consolidation, risk abatement, performance, and life-cycle cost. Should technologies that offer such advantages be identified, DOE may request a revision/modification of the STP in accordance with the provisions of Consent Order 95-22-HW.The Compliance Plan Volume (Volume I) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions (LDR). Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume II) and is provided for information.

  5. Currently approved and emerging oral therapies in multiple sclerosis: An update for the ophthalmologist.

    PubMed

    Eckstein, Christopher; Bhatti, M Tariq

    2016-01-01

    Although our understanding of multiple sclerosis (MS) has grown substantially, its cause remains unknown. Nonetheless, in the past 3 decades, there have been tremendous advancements in the development of disease-modifying drugs (DMDs). In July 1993, the United States Food and Drug Administration approved the first disease-modifying drug-interferon β- and there are currently 13 medications approved for use in relapsing MS. All the early medications are administered either as a subcutaneous or intramuscular injection, and despite the clinical efficacy and safety of these medications, many patients were hampered by the inconvenience of injections and injection-related side effects. In September 2010, the first oral DMD-fingolimod-was approved. Since then, 2 additional oral DMDs (teriflunomide and dimethyl fumarate) have been approved, and several other oral medications are being evaluated in extensive MS development programs. Because of frequent ocular involvement, ophthalmologists are often involved in the care of MS patients and therefore need to be aware of the current treatment regimens prescribed by neurologists, some of which can have significant ophthalmic adverse events. We update the current advancements in the treatment of MS and discuss the published clinical data on the efficacy and safety of the currently approved and emerging oral therapies in MS. PMID:26703886

  6. The NCGC pharmaceutical collection: a comprehensive resource of clinically approved drugs enabling repurposing and chemical genomics.

    PubMed

    Huang, Ruili; Southall, Noel; Wang, Yuhong; Yasgar, Adam; Shinn, Paul; Jadhav, Ajit; Nguyen, Dac-Trung; Austin, Christopher P

    2011-04-27

    Small-molecule compounds approved for use as drugs may be "repurposed" for new indications and studied to determine the mechanisms of their beneficial and adverse effects. A comprehensive collection of all small-molecule drugs approved for human use would be invaluable for systematic repurposing across human diseases, particularly for rare and neglected diseases, for which the cost and time required for development of a new chemical entity are often prohibitive. Previous efforts to build such a comprehensive collection have been limited by the complexities, redundancies, and semantic inconsistencies of drug naming within and among regulatory agencies worldwide; a lack of clear conceptualization of what constitutes a drug; and a lack of access to physical samples. We report here the creation of a definitive, complete, and nonredundant list of all approved molecular entities as a freely available electronic resource and a physical collection of small molecules amenable to high-throughput screening.

  7. 75 FR 75169 - Notice of Request for Extension of Approval of an Information Collection; Update of Nursery Stock...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-02

    ... Approval of an Information Collection; Update of Nursery Stock Regulations AGENCY: Animal and Plant Health... collection associated with regulations for the importation of nursery stock into the United States. DATES: We... regulations for the importation of nursery stock into the United States, contact Mr. Alex Belano, Branch...

  8. Safety update on the use of recombinant activated factor VII in approved indications.

    PubMed

    Neufeld, Ellis J; Négrier, Claude; Arkhammar, Per; Benchikh el Fegoun, Soraya; Simonsen, Mette Duelund; Rosholm, Anders; Seremetis, Stephanie

    2015-06-01

    This updated safety review summarises the large body of safety data available on the use of recombinant activated factor VII (rFVIIa) in approved indications: haemophilia with inhibitors, congenital factor VII (FVII) deficiency, acquired haemophilia and Glanzmann's thrombasthenia. Accumulated data up to 31 December 2013 from clinical trials as well as post-marketing data (registries, literature reports and spontaneous reports) were included. Overall, rFVIIa has shown a consistently favourable safety profile, with no unexpected safety concerns, in all approved indications. No confirmed cases of neutralising antibodies against rFVIIa have been reported in patients with congenital haemophilia, acquired haemophilia or Glanzmann's thrombasthenia. The favourable safety profile of rFVIIa can be attributed to the recombinant nature of rFVIIa and its localised mechanism of action at the site of vascular injury. Recombinant FVIIa activates factor X directly on the surface of activated platelets, which are present only at the site of injury, meaning that systemic activation of coagulation is avoided and the risk of thrombotic events (TEs) thus reduced. Nonetheless, close monitoring for signs and symptoms of TE is warranted in all patients treated with any pro-haemostatic agent, including rFVIIa, especially the elderly and any other patients with concomitant conditions and/or predisposing risk factors to thrombosis.

  9. 75 FR 340 - Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ...- 17-09); Whereas, notice inviting public comment has been given in the Federal Register (74 FR 8052... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF COMMERCE Foreign-Trade Zones Board Approval for Expansion of Subzone 22F, Abbott Molecular, Inc....

  10. How do patent rights affect regulatory approvals and data exclusivity rights for pharmaceuticals in the EU?

    PubMed

    Bogaert, Peter; Van Keymeulen, Eveline

    2012-09-01

    This article sheds light on the relationship, or rather, absence of a relationship, between patent rights and regulatory approval procedures in the EU. The principle of 'patent linkage' has long been recognized and applied by regulatory authorities in the USA. The European Commission, however, opposes the idea of linking patent rights to marketing authorizations and pricing and reimbursement decisions. This position is grounded in Article 126 of Directive 2001/83 and is expected not to change anytime soon, given the clear reaffirmation thereof in the recent Sector Inquiry Report and Transparency Directive Proposal. Therefore, the European Medicines Agency or national authorities are not permitted to refuse approval and, likely, pricing and reimbursement of a generic when the innovative reference product is still protected by a patent. The authors, however, advocate that there are strong legal arguments for patent holders to challenge regulatory decisions that did not respect their patent rights before the competent national courts. PMID:24236878

  11. 78 FR 54200 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Maintenance Plan Update...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-03

    ... Plan Update for Lake County, Indiana for Sulfur Dioxide AGENCY: Environmental Protection Agency (EPA..., Indiana sulfur dioxide (SO 2 ) maintenance area. This plan update demonstrates that Lake County...

  12. A Review of Randomized Trials of Approved Pharmaceutical Agents for Macular Edema Secondary to Retinal Vein Occlusion.

    PubMed

    Wang, Jia-Kang

    2016-01-01

    There are 3 approved pharmaceutical agents for treating macular edema secondary to retinal vein occlusion (RVO): dexamethasone (a corticosteroid) implant and ranibizumab and aflibercept (both antivascular endothelial growth factor agents). All show a superior ability to improve vision and reduce macular thickness in comparison with sham injections or macular grid laser treatment. Prompt treatment with these agents may lead to a better outcome. A review of randomized trials of injected aflibercept or ranibizumab reveals protocol variations. They include "as needed" injections until functional and anatomical changes are achieved, preceded by either 1 injection or 3 to 6 monthly injections as loading doses. Ocular and systemic adverse effects of vascular endothelial growth factor antagonists for macular edema secondary to RVO are rarely severe. The antiedematous response to a single intravitreal dexamethasone implant is maximal 1 to 3 months after the injection. Intraocular pressure elevation and cataract aggravation should be monitored after the use of intravitreal dexamethasone implants. Intravitreal dexamethasone implants and ranibizumab injections reduce not only macular edema, but also the risk of retinal ischemia and neovascularization in patients with RVO. PMID:26692257

  13. A Comprehensive Updated Review of Pharmaceutical and Nonpharmaceutical Treatment for NAFLD

    PubMed Central

    Hossain, Newaz; Kanwar, Pushpjeet; Mohanty, Smruti R.

    2016-01-01

    Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the western world with prevalence of 20–33%. NAFLD comprises a pathological spectrum. Nonalcoholic fatty liver (NAFL) is at one end and consists of simple hepatic steatosis. On the contrary, nonalcoholic steatohepatitis (NASH) consists of steatosis, inflammation, and ballooning degeneration and can progress to cirrhosis. Despite the rising incidence, definitive treatment for NAFLD, specifically NASH, has not yet been established. Lifestyle modification with dietary changes combined with regular aerobic exercise, along with multidisciplinary approach including cognitive behavior therapy, has been shown to be an effective therapeutic option, even without a significant weight loss. Pioglitazone and vitamin E have shown to be most effective in NASH patients. Surgery and weight loss medication are effective means of weight loss but can potentially worsen NASH related fibrosis. Other agents such as n-3 polyunsaturated fatty acids, probiotics, and pentoxifylline along with herbal agent such as milk thistle as well as daily intake of coffee have shown potential benefits, but further well organized studies are definitely warranted. This review focuses on the available evidence on pharmaceutical and nonpharmaceutical therapy in the treatment and the prevention of NAFLD, primarily NASH. PMID:27006654

  14. A Comprehensive Updated Review of Pharmaceutical and Nonpharmaceutical Treatment for NAFLD.

    PubMed

    Hossain, Newaz; Kanwar, Pushpjeet; Mohanty, Smruti R

    2016-01-01

    Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the western world with prevalence of 20-33%. NAFLD comprises a pathological spectrum. Nonalcoholic fatty liver (NAFL) is at one end and consists of simple hepatic steatosis. On the contrary, nonalcoholic steatohepatitis (NASH) consists of steatosis, inflammation, and ballooning degeneration and can progress to cirrhosis. Despite the rising incidence, definitive treatment for NAFLD, specifically NASH, has not yet been established. Lifestyle modification with dietary changes combined with regular aerobic exercise, along with multidisciplinary approach including cognitive behavior therapy, has been shown to be an effective therapeutic option, even without a significant weight loss. Pioglitazone and vitamin E have shown to be most effective in NASH patients. Surgery and weight loss medication are effective means of weight loss but can potentially worsen NASH related fibrosis. Other agents such as n-3 polyunsaturated fatty acids, probiotics, and pentoxifylline along with herbal agent such as milk thistle as well as daily intake of coffee have shown potential benefits, but further well organized studies are definitely warranted. This review focuses on the available evidence on pharmaceutical and nonpharmaceutical therapy in the treatment and the prevention of NAFLD, primarily NASH. PMID:27006654

  15. Analysis of the landscape of biologically-derived pharmaceuticals in Europe: dominant production systems, molecule types on the rise and approval trends.

    PubMed

    Kyriakopoulos, Sarantos; Kontoravdi, Cleo

    2013-02-14

    A thorough sort of the human drugs approved by the European Medicines Agency (EMA) between its establishment in 1995 until June 2012 is presented herein with a focus on biologically-derived pharmaceuticals. Over 200 (33%) of the 640 approved therapeutic drugs are derived from natural sources, produced via recombinant DNA technology, or generated through virus propagation. A breakdown based on production method, type of molecule and therapeutic category is presented. Current EMA approvals demonstrate that mammalian cells are the only choice for glycoprotein drugs, with Chinese hamster ovary cells being the dominant hosts for their production. On the other hand, bacterial cells and specifically Escherichia coli are the dominant hosts for protein-based drugs, followed by the yeast Saccharomyces cerevisiae. The latter is the dominant host for recombinant vaccine production, although egg-based production is still the main platform of vaccine provision. Our findings suggest that the majority of biologically-derived drugs are prescribed for cancer and related conditions, as well as the treatment of diabetes. The approval rate for biologically-derived drugs shows a strong upward trend for monoclonal antibodies and fusion proteins since 2009, while hormones, antibodies and growth factors remain the most populous categories. Despite a clear pathway for the approval of biosimilars set by the EMA and their potential to drive sales growth, we have only found approved biosimilars for three molecules. In 2012 there appears to be a slow-down in approvals, which coincides with a reported decline in the growth rate of biologics sales. PMID:23262060

  16. Updating a near-infrared multivariate calibration model formed with lab-prepared pharmaceutical tablet types to new tablet types in full production.

    PubMed

    Farrell, Jeremy A; Higgins, Kevin; Kalivas, John H

    2012-03-01

    Determining active pharmaceutical ingredient (API) tablet concentrations rapidly and efficiently is of great importance to the pharmaceutical industry in order to assure quality control. Using near-infrared (NIR) spectra measured on tablets in conjunction with multivariate calibration has been shown to meet these objectives. However, the calibration is typically developed under one set of conditions (primary conditions) and new tablets are produced under different measurement conditions (secondary conditions). Hence, the accuracy of multivariate calibration is limited due to differences between primary and secondary conditions such as tablet variances (composition, dosage, and production processes and precision), different instruments, and/or new environmental conditions. This study evaluates application of Tikhonov regularization (TR) to update NIR calibration models developed in a controlled primary laboratory setting to predict API tablet concentrations manufactured in full production where conditions and tablets are significantly different than in the laboratory. With just a few new tablets from full production, it is found that TR provides reduced prediction errors by as much as 64% in one situation compared to no model-updating. TR prediction errors are reduced by as much as 51% compared to local centering, another calibration maintenance method. The TR updated primary models are also found to predict as well as a full calibration model formed in the secondary conditions.

  17. 78 FR 48323 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... nitrogen oxides (NO X ) and volatile organic compounds (VOCs), and an updated point source inventory for NO..., Incorporation by reference, Nitrogen dioxide, Ozone, Volatile organic compounds. Dated: July 18, 2013. W.C... inventory for nitrogen oxides (NO X ) and volatile organic compounds (VOCs) for the Lancaster 1997...

  18. 78 FR 78310 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ... (MVEBs) for nitrogen oxides (NO X ) and volatile organic compounds (VOCs) for the 1997 8-Hour Ozone... Maintenance Area''). The other SIP revision updates the point source inventory for NO X and VOCs. In the Final... files should avoid the use of special characters, any form of encryption, and be free of any defects...

  19. 75 FR 81474 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Update to Materials...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-28

    ... to make them part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the procedures for... February 10, 2005 (70 FR 7024), EPA published a Federal Register beginning the new IBR procedure for West Virginia. On February 28, 2007 (72 FR 8903) and February 10, 2009 (74 FR 6542), EPA published updates...

  20. 77 FR 35279 - Approval and Promulgation of Implementation Plans; Arizona; Update to Stage II Gasoline Vapor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ...'s Submittal On October 3, 2011 (76 FR 61062), we proposed to approve a revision to the Arizona State... FR 41731, at 41734 (July 15, 2011). \\2\\ By letter dated April 12, 2011, ADEQ substituted the statutes.... See 61 FR 3578 (February 1, 1996). MCAQDM's stage I vapor recovery program and related rule are...

  1. 76 FR 61062 - Approval and Promulgation of Implementation Plans; Arizona; Update to Stage II Gasoline Vapor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ... Refueling Vapor Recovery and Stage II Waiver,'' 76 FR 41731, at 41734 (July 15, 2011). \\2\\ By letter dated.... See 61 FR 3578 (February 1, 1996). MCAQDM's stage I vapor recovery program and related rule are not... provisions in the Arizona SIP? On November 1, 1994 (59 FR 54521), we approved Arizona's stage II...

  2. 78 FR 11984 - Approval and Promulgation of Implementation Plans; State of Hawaii; Update to Materials...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ...-26 Fugitive dust...... 11/29/1982 08/18/1983, 48 FR 37403 11-60-27 Incineration....... 11/29/1982 08.... 11-60.1-42 Waste gas disposal. 11/14/2003 4/27/2012, 77 FR New regulation. 25084. 11-60.1-51... (62 FR 27968), EPA revised the procedures for incorporating by reference federally-approved SIPs, as...

  3. Fusion strategies for selecting multiple tuning parameters for multivariate calibration and other penalty based processes: A model updating application for pharmaceutical analysis.

    PubMed

    Tencate, Alister J; Kalivas, John H; White, Alexander J

    2016-05-19

    New multivariate calibration methods and other processes are being developed that require selection of multiple tuning parameter (penalty) values to form the final model. With one or more tuning parameters, using only one measure of model quality to select final tuning parameter values is not sufficient. Optimization of several model quality measures is challenging. Thus, three fusion ranking methods are investigated for simultaneous assessment of multiple measures of model quality for selecting tuning parameter values. One is a supervised learning fusion rule named sum of ranking differences (SRD). The other two are non-supervised learning processes based on the sum and median operations. The effect of the number of models evaluated on the three fusion rules are also evaluated using three procedures. One procedure uses all models from all possible combinations of the tuning parameters. To reduce the number of models evaluated, an iterative process (only applicable to SRD) is applied and thresholding a model quality measure before applying the fusion rules is also used. A near infrared pharmaceutical data set requiring model updating is used to evaluate the three fusion rules. In this case, calibration of the primary conditions is for the active pharmaceutical ingredient (API) of tablets produced in a laboratory. The secondary conditions for calibration updating is for tablets produced in the full batch setting. Two model updating processes requiring selection of two unique tuning parameter values are studied. One is based on Tikhonov regularization (TR) and the other is a variation of partial least squares (PLS). The three fusion methods are shown to provide equivalent and acceptable results allowing automatic selection of the tuning parameter values. Best tuning parameter values are selected when model quality measures used with the fusion rules are for the small secondary sample set used to form the updated models. In this model updating situation, evaluation of

  4. Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation

    NASA Astrophysics Data System (ADS)

    Ayoub, Bassam M.

    2016-11-01

    New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2-12 μg mL- 1 for both drugs using simultaneous equation with LOD values equal to 0.20 μg mL- 1 and 0.19 μg mL- 1, LOQ values equal to 0.59 μg mL- 1 and 0.58 μg mL- 1 for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2-10 μg mL- 1. The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets.

  5. Pharmaceutical structure montages as catalysts for design and discovery.

    PubMed

    Njarðarson, Jon T

    2012-05-01

    Majority of pharmaceuticals are small molecule organic compounds. Their structures are most effectively described and communicated using the graphical language of organic chemistry. A few years ago we decided to harness this powerful language to create new educational tools that could serve well for data mining and as catalysts for discovery. The results were the Top 200 drug posters, which we have posted online for everyone to enjoy and update yearly. This article details the origin and motivation for our design and highlights the value of this graphical format by presenting and analyzing a new pharmaceutical structure montage (poster) focused on US FDA approved drugs in 2011.

  6. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2014-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

  7. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2014-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part. PMID:24964711

  8. GW-1000. GW Pharmaceuticals.

    PubMed

    Smith, Paul F

    2004-07-01

    GW Pharmaceuticals is developing GW-1000 (Sativex), a narrow ratio delta9-tetrahydrocannabinol:cannabidiol product for the potential treatment of multiple sclerosis, spinal cord injury, neurogenic pain and peripheral neuropathy. In March 2003, the company filed for approval for the treatment of MS with the UK Medicines Control Agency, and in May 2004, filed for new drug submission with Health Canada. PMID:15298072

  9. Simultaneous spectrophotometric determination of indacaterol and glycopyrronium in a newly approved pharmaceutical formulation using different signal processing techniques of ratio spectra

    NASA Astrophysics Data System (ADS)

    Abdel Ghany, Maha F.; Hussein, Lobna A.; Magdy, Nancy; Yamani, Hend Z.

    2016-03-01

    Three spectrophotometric methods have been developed and validated for determination of indacaterol (IND) and glycopyrronium (GLY) in their binary mixtures and novel pharmaceutical dosage form. The proposed methods are considered to be the first methods to determine the investigated drugs simultaneously. The developed methods are based on different signal processing techniques of ratio spectra namely; Numerical Differentiation (ND), Savitsky-Golay (SG) and Fourier Transform (FT). The developed methods showed linearity over concentration range 1-30 and 10-35 (μg/mL) for IND and GLY, respectively. The accuracy calculated as percentage recoveries were in the range of 99.00%-100.49% with low value of RSD% (< 1.5%) demonstrating an excellent accuracy of the proposed methods. The developed methods were proved to be specific, sensitive and precise for quality control of the investigated drugs in their pharmaceutical dosage form without the need for any separation process.

  10. Simultaneous spectrophotometric determination of indacaterol and glycopyrronium in a newly approved pharmaceutical formulation using different signal processing techniques of ratio spectra.

    PubMed

    Abdel Ghany, Maha F; Hussein, Lobna A; Magdy, Nancy; Yamani, Hend Z

    2016-03-15

    Three spectrophotometric methods have been developed and validated for determination of indacaterol (IND) and glycopyrronium (GLY) in their binary mixtures and novel pharmaceutical dosage form. The proposed methods are considered to be the first methods to determine the investigated drugs simultaneously. The developed methods are based on different signal processing techniques of ratio spectra namely; Numerical Differentiation (ND), Savitsky-Golay (SG) and Fourier Transform (FT). The developed methods showed linearity over concentration range 1-30 and 10-35 (μg/mL) for IND and GLY, respectively. The accuracy calculated as percentage recoveries were in the range of 99.00%-100.49% with low value of RSD% (<1.5%) demonstrating an excellent accuracy of the proposed methods. The developed methods were proved to be specific, sensitive and precise for quality control of the investigated drugs in their pharmaceutical dosage form without the need for any separation process.

  11. Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

    PubMed Central

    Pinkerton, JoAnn V.; Pickar, James H.

    2016-01-01

    Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Results: Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. Conclusions: The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk. PMID:26418479

  12. Ospemifene: first global approval.

    PubMed

    Elkinson, Shelley; Yang, Lily P H

    2013-05-01

    Ospemifene (Osphena™) is an oral selective estrogen receptor modulator (SERM), with tissue-specific estrogenic agonist/antagonist effects. QuatRx Pharmaceuticals conducted the global development of the agent before licensing it to Shionogi for regulatory filing and commercialization worldwide. Ospemifene is the first non-estrogen treatment approved for moderate to severe dyspareunia in women with menopause-related vulvar and vaginal atrophy. The drug is approved in the USA, and application for EU regulatory approval is underway. This article summarizes the milestones in the development of ospemifene leading to this first approval for moderate to severe dyspareunia, a symptom of postmenopausal vulvar and vaginal atrophy.

  13. Pharmaceutical Psychology.

    ERIC Educational Resources Information Center

    Dolinsky, Donna

    1979-01-01

    Defines areas that could comprise pharmaceutical psychology. The discussion includes a review of literature, outline of areas in pharmacy in which psychologists could become involved, description of a project involving the application of psychology to pharmacy, and analysis of the concept of pharmaceutical psychology. A 99-item bibliography is…

  14. QbD implementation and Post Approval Lifecycle Management (PALM).

    PubMed

    Ohage, Ettore; Iverson, Raquel; Krummen, Lynne; Taticek, Ron; Vega, Maria

    2016-09-01

    Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11) [1-3]. An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter describes concepts for implementing the control strategy for a monoclonal antibody including a Design Space for routine commercial manufacturing, and the Post Approval Lifecycle Management (PALM) plan that is used to manage any remaining risks during the commercial lifecycle. The PALM plan is part of the submitted dossier in the regional section and serves as a regulatory agreement between the manufacturer and the health authority specifying how process and product attributes are monitored to ensure both remain within a controlled state post-approval, process parameter changes are managed within the design space, and the control system is updated as necessary based on further process and product knowledge.

  15. QbD implementation and Post Approval Lifecycle Management (PALM).

    PubMed

    Ohage, Ettore; Iverson, Raquel; Krummen, Lynne; Taticek, Ron; Vega, Maria

    2016-09-01

    Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11) [1-3]. An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter describes concepts for implementing the control strategy for a monoclonal antibody including a Design Space for routine commercial manufacturing, and the Post Approval Lifecycle Management (PALM) plan that is used to manage any remaining risks during the commercial lifecycle. The PALM plan is part of the submitted dossier in the regional section and serves as a regulatory agreement between the manufacturer and the health authority specifying how process and product attributes are monitored to ensure both remain within a controlled state post-approval, process parameter changes are managed within the design space, and the control system is updated as necessary based on further process and product knowledge. PMID:27449920

  16. Pharmaceutical virtue.

    PubMed

    Martin, Emily

    2006-06-01

    In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

  17. Efinaconazole: first global approval.

    PubMed

    Patel, Trina; Dhillon, Sohita

    2013-11-01

    A non-lacquer 10% topical solution of efinaconazole, developed by Valeant Pharmaceuticals International, received its first global approval in Canada in October 2013 for the treatment of onychomycosis. The product is under regulatory review in the US and Japan. The mechanism of anti-fungal activity of efinaconazole, a small-molecule triazole compound, appears to be similar to that of other anti-fungal triazoles, namely ergosterol synthesis inhibition. In particular, it appears to inhibit 14α demethylase, an enzyme involved in the conversion of lanosterol to ergosterol, resulting in secondary degenerative changes. This article summarizes the milestones in the development of efinaconazole leading to this first approval for onychomycosis.

  18. Pimavanserin: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Pimavanserin (Nuplazid™) is a selective and potent serotonin 2A (5-HT2A) receptor inverse agonist and antagonist developed by ACADIA Pharmaceuticals that has been approved in the US as a treatment for patients with hallucinations and delusions associated with Parkinson's disease psychosis. Up to 60 % of patients with Parkinson's disease may develop Parkinson's disease psychosis, which is associated with increased morbidity and mortality and has few treatment options. This article summarizes the milestones in the development of pimavanserin leading to this first approval for the treatment of hallucinations and delusions in patients with Parkinson's disease psychosis. PMID:27262680

  19. Metreleptin: first global approval.

    PubMed

    Chou, Ken; Perry, Caroline M

    2013-06-01

    Metreleptin is an analogue of the human hormone leptin being developed by Amylin Pharmaceuticals (a subsidiary of Bristol-Myers Squibb) for the subcutaneous treatment of metabolic disorders including lipodystrophy. The compound is expected to improve insulin sensitivity, hypertriglyceridaemia and hyperglycaemia in patients with lipodystrophy who are unresponsive to conventional treatment. Metreleptin has been approved in Japan as a leptin therapy for the treatment of lipodystrophy. Amylin has also completed a submission for regulatory approval to the US FDA for metreleptin in the treatment of diabetes mellitus and/or hypertriglyceridaemia in patients with rare forms of lipodystrophy. Clinical development of the drug is also underway in the USA for the treatment of type 1 diabetes. Amgen was previously assessing the use of metreleptin as a treatment for amenorrhoea; however, it appears that development in this indication has been discontinued. This article summarizes the milestones in the development of metreleptin leading to this first approval for lipodystrophy.

  20. Acotiamide: first global approval.

    PubMed

    Nowlan, Mary L; Nolan, Mary L; Scott, Lesley J

    2013-08-01

    Acotiamide (Acofide(®)), an oral first-in-class prokinetic drug, is under global development by Zeria Pharmaceutical Co. Ltd and Astellas Pharma Inc. for the treatment of patients with functional dyspepsia. The drug modulates upper gastrointestinal motility to alleviate abdominal symptoms resulting from hypomotility and delayed gastric emptying. It exerts its activity in the stomach via muscarinic receptor inhibition, resulting in enhanced acetylcholine release and inhibition of acetylcholinesterase activity. Unlike other prokinetic drugs that are utilized in the management of functional dyspepsia, acotiamide shows little/no affinity for serotonin or dopamine D2 receptors. Acotiamide is the world's first approved treatment for functional dyspepsia diagnosed by Rome III criteria, with its first approval occurring in Japan. Phase III trials in this patient population are in preparation in Europe, with phase II trials completed in the USA and Europe. This article summarizes the milestones in the development of acotiamide, leading to its first approval for use in patients with functional dyspepsia.

  1. Pharmaceutical Analysis as a Branch of Pharmaceutics

    ERIC Educational Resources Information Center

    Connors, Kenneth A.

    1977-01-01

    Pharmaceutical analysis is incorporated into the pharmaceutics component of the undergraduate curriculum at the University of Wisconsin. Many collaborative demonstrations, lectures, and laboratory experiments can illustrate the close relationship between analysis and modern pharmacy practice. (Author/LBH)

  2. Resuscitation and rescue of the pharmaceutical detail: a prescriber-drug representative collaboration.

    PubMed

    Kale, Scott A; Barkin, Robert L

    2009-01-01

    The traditional pharmaceutical detail must be revised to meet current prescriber presentation and interaction needs. Best practice and evidence-based clinical strategies demands, an expanded database describing prescribable pharmaceutical therapies. We present a format for the structure of a functional database for pharmaceuticals and a means by which the data can be introduced, updated and instituted. PMID:19618754

  3. Drug information residency rotation with pharmaceutical industry.

    PubMed

    Cramer, R L

    1986-01-01

    A drug information rotation in pharmaceutical industry may be elected as a component of a hospital pharmacy residency program. Program objectives include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the pharmaceutical industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of various departments within the company. During the rotation, the resident serves as a member of the Drug Information Service. Resident activities include participating in interviews with corporate professionals, updating pharmacokinetic profiles, responding to drug information requests and participating in other information projects. This rotation enables the resident to better understand pharmaceutical industry's concerns and relate these concerns to clinical pharmacy practice. PMID:10277398

  4. Riociguat: first global approval.

    PubMed

    Conole, Daniel; Scott, Lesley J

    2013-11-01

    Riociguat (Adempas(®)), an oral first-in-class soluble guanylate cyclase (sGC) stimulator, is under global development by Bayer Healthcare Pharmaceuticals Inc. for the treatment of adult patients with inoperable or chronic/persistent chronic thromboembolic pulmonary hypertension (CTEPH) and for the treatment of adult patients with pulmonary arterial hypertension (PAH). The drug directly stimulates sGC in a nitric oxide independent manner, thereby increasing the sensitivity of sGC to nitric oxide, leading to increased cyclic guanosine monophosphate generation (a key signalling molecule involved in regulating vascular tone, proliferation, fibrosis and inflammation). Riociguat is the world's first approved pharmacotherapy for CTEPH, with its first global approval in this indication occurring in Canada. It has subsequently been approved in the USA for the treatment of patients with CTEPH and also received its first global approval in patients with PAH in the USA. It is undergoing regulatory review for these indications in Europe and for use in patients with CTEPH in Japan. This article summarizes the milestones in the development of riociguat, leading to its first global approvals in patients with CTEPH and PAH.

  5. Linaclotide: first global approval.

    PubMed

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch. PMID:23083112

  6. Linaclotide: first global approval.

    PubMed

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  7. Canagliflozin: first global approval.

    PubMed

    Elkinson, Shelley; Scott, Lesley J

    2013-06-01

    Canagliflozin (Invokana™), an oral selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, is under global development with Mitsubishi Tanabe Pharma and Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, for the treatment of type 2 diabetes mellitus. SGLT2 are mainly located in the proximal tubule of the kidney and are involved in the reabsorption of filtered glucose from the glomeruli into the body. Inhibition of SGLT2 lowers blood glucose in an insulin independent manner as a consequence of blocking reabsorption of filtered glucose in the glomeruli, thereby increasing urinary excretion of glucose and, in turn, potentially reducing bodyweight. Canagliflozin is the first SGLT2 inhibitor to be approved in the USA and is under regulatory review in the EU. This article summarizes the milestones in the development of canagliflozin, leading to its first approval for use in adults with type 2 diabetes.

  8. Alirocumab: First Global Approval.

    PubMed

    Markham, Anthony

    2015-09-01

    Alirocumab (Praluent®) is a fully human monoclonal antibody developed by Regeneron Pharmaceuticals and Sanofi that has been approved in the US as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a down regulator of liver low-density lipoprotein (LDL)-receptors-thereby increasing the ability of the liver to bind LDL-cholesterol (LDL-C) and reducing levels of LDL-C in blood. It has been shown to reduce LDL-C levels in patients with hypercholesterolaemia, including HeFH, both as monotherapy and in conjunction with statin therapy. This article summarizes the milestones in the development of alirocumab leading to this first approval. PMID:26370210

  9. 7 CFR 1710.205 - Minimum approval requirements for all load forecasts.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... computer software applications. RUS will evaluate borrower load forecasts for readability, understanding... update of an approved load forecast as loan support, the borrower must demonstrate that the approved load... coordinate preparation of their respective load forecasts, updates of load forecasts, and approved...

  10. Patient access to pharmaceuticals: an international comparison.

    PubMed

    Cohen, Joshua; Faden, Laura; Predaris, Susan; Young, Brian

    2007-09-01

    We have identified eight sub-dimensions of patient access to pharmaceuticals: marketing approvals, time of marketing approval, coverage, cost sharing, conditions of reimbursement, speed from marketing approval to reimbursement, extent to which beneficiaries control choice of their drug benefit, and evenness of the availability of drugs to the population. For a sample of commonly used best-selling drugs in the United States (US), we measured these eight access sub-dimensions across four health systems: France, the Netherlands, the United Kingdom (UK), and the US. Although the US approved between 15 and 18% more drugs than the other three countries, the US was slower than France and the UK to approve drugs licensed in all four countries. The percentage of drugs covered is approximately the same for all four countries. For covered drugs, we observe the least cost sharing by patients in the Netherlands. The Netherlands imposes conditions of reimbursement on a much larger percentage of drugs. France seems to be the slowest in respect of speed from marketing approval to reimbursement. The US is the most flexible in terms of the extent to which beneficiaries control their choice of drug benefit but it is the least universal in terms of evenness of the availability of drugs to the population. Our study confirms the frequently cited problems of access in European countries: lag between marketing approval and reimbursement, and inflexibility in respect of the extent to which beneficiaries control their choice of drug benefit. At the same time, our study confirms, qualitatively, different kinds of access problems in the US: relatively high patient cost sharing for pharmaceuticals, and wide variation in coverage. PMID:17279403

  11. 78 FR 26301 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Approval of Texas Low...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ...EPA is proposing approval of a revision to the Texas State Implementation Plan (SIP) concerning the Texas Low Emission Diesel (TxLED) Fuel rules. The revisions clarify existing definitions and provisions, revise the approval procedures for alternative diesel fuel formulations, add new registration requirements, and update the rule to reflect the current program status because the rule is now......

  12. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2011-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format. PMID:21699061

  13. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2011-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

  14. 'Linkage' pharmaceutical evergreening in Canada and Australia

    PubMed Central

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

    'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines. PMID:17543113

  15. Biological and Pharmaceutical Nanomaterials

    NASA Astrophysics Data System (ADS)

    Kumar, Challa S. S. R.

    2006-01-01

    This first comprehensive yet concise overview of all important classes of biological and pharmaceutical nanomaterials presents in one volume the different kinds of natural biological compounds that form nanomaterials or that may be used to purposefully create them. This unique single source of information brings together the many articles published in specialized journals, which often remain unseen by members of other, related disciplines. Covering pharmaceutical, nucleic acid, peptide and DNA-Chitosan nanoparticles, the book focuses on those innovative materials and technologies needed for the continued growth of medicine, healthcare, pharmaceuticals and human wellness. For chemists, biochemists, cell biologists, materials scientists, biologists, and those working in the pharmaceutical and chemical industries.

  16. [Healthy pharmaceutical policy].

    PubMed

    González Pier, Eduardo

    2008-01-01

    Today, the pharmaceutical industry is experiencing a profound transition. Globalization and technological advancement represent the principal pressures for change in the market, where it is increasingly more difficult for this type of industry to efficiently recoup the growing cost of innovation. Mexico needs to analyze the policy implications of these change factors and promote, in the pharmaceutical market, policies that maximize health gains on invested resources. Pharmaceutical policy offers a rare example for a complementary approach between a sound health policy and an efficient economic policy; that is, a "healthy pharmaceutical policy."

  17. [Pharmaceuticals as pollution].

    PubMed

    Grung, Merete; Langford, Katherine; Thomas, Kevin V

    2012-05-29

    The pharmaceuticals we humans use to treat illness and disease typically enter the aquatic environment via the sewer network and wastewater treatment works. Understanding the risks posed to the aquatic environment by these chemicals requires an understanding of the concentrations that exist in the environment and whether they are sufficiently high to have adverse effects on aquatic organisms. The main source of pharmaceuticals to wastewater treatment works is pharmaceuticals used by the general population. Only a small contribution is believed to come from hospitals. The predicted environmental concentrations of pharmaceuticals suggest that certain pharmaceuticals may pose a risk to the environment, but measurement of the actual concentrations present in effluents and recipient waters suggest that sophisticated wastewater treatment is effective for significantly reducing effluent concentrations, and that environmental concentrations of pharmaceuticals, in the Oslo Fjord, for example, are generally low. Humans also excrete the metabolites of the pharmaceuticals that they have used and these too may be released into the environment, sometimes in greater concentrations than the parent drug. The occurrence of most pharmaceuticals and their metabolites in the environment poses little acute environmental risk. However, the effects of long-term chronic exposure to these compounds are still poorly understood and the long-terms risks to the environment are still not clear. What is clear is that certain pharmaceuticals pose a greater environmental risk than others, and that where possible this knowledge should be used to inform users of more environmentally friendly alternatives.

  18. Radiation treatment of pharmaceuticals

    NASA Astrophysics Data System (ADS)

    Dám, A. M.; Gazsó, L. G.; Kaewpila, S.; Maschek, I.

    1996-03-01

    Product specific doses were calculated for pharmaceuticals to be radiation treated. Radio-pasteurization dose were determined for some heat sensitive pharmaceutical basic materials (pancreaton, neopancreatin, neopancreatin USP, duodenum extract). Using the new recommendation (ISO standards, Method 1) dose calculations were performed and radiation sterilization doses were determined for aprotinine and heparine Na.

  19. 76 FR 51049 - Notice of Submission of Proposed Information Collection to OMB; FHA Lender Approval, Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... URBAN DEVELOPMENT Notice of Submission of Proposed Information Collection to OMB; FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports by FHA Approved Lenders AGENCY: Office of the Chief... information is required for: (1) FHA Lender Approval; (2) Annual renewal of each FHA Lender's Approval;...

  20. Ovation Pharmaceuticals, Inc.

    PubMed

    Deutsch, Barry

    2002-11-01

    Ovation Pharmaceuticals, Inc. is a privately held specialty pharmaceutical company that focuses on products in central nervous system (CNS) disorders, oncology and other therapeutic areas where a small number of specialized physicians treat patients. Ovation serves unmet medical needs by acquiring underpromoted branded pharmaceutical products and promising late-stage development products no longer being actively promoted or developed by larger companies. Ovation supports acquired products through active sales and marketing activities and a clinical development program focused on new formulations, new indications and other product improvements. In April 2002, Ovation received a US$150 million commitment in private equity financing, believed to be the largest private equity investment received to date by an early-stage specialty pharmaceutical firm. Ovation used a portion of those funds to purchase its first two products from a major pharmaceutical company in August 2002.

  1. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale.

  2. Macitentan: first global approval.

    PubMed

    Patel, Trina; McKeage, Kate

    2014-01-01

    Macitentan (Opsumit®) is a novel dual endothelin receptor antagonist (ERA) with sustained receptor binding properties developed by Actelion Pharmaceuticals Ltd. In October 2013, oral macitentan 10 mg once daily received its first global approval in the US, followed closely by Canada, for the treatment of pulmonary arterial hypertension (PAH). The drug has also received a positive opinion in the EU from the Committee for Medicinal Products for Human Use for the treatment of PAH, and is under regulatory review in several other countries for the same indication. Endothelin (ET)-1 influences pathological changes via two ET receptor subtypes (ETA and ETB), to which it binds with high affinity. ET-1 is implicated in several forms of vascular disease making it a valid target for the treatment of pulmonary vascular diseases such as PAH. Clinical development is underway for other indications, including Eisenmenger syndrome, ischaemic digital ulcers secondary to systemic sclerosis, and glioblastoma. Macitentan was also evaluated in idiopathic pulmonary fibrosis; however, a phase 2 trial did not meet its primary endpoint and further investigation in this indication was discontinued. Macitentan was developed by modifying the structure of bosentan in the search for an optimal dual ERA with improved efficacy and tolerability compared with other ERAs. This article summarizes the milestones in the development of macitentan leading to this first approval for PAH.

  3. Obinutuzumab: first global approval.

    PubMed

    Cameron, Fiona; McCormack, Paul L

    2014-01-01

    Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death. Obinutuzumab is a type II anti-CD20 antibody that induces enhanced direct cell death. The monoclonal antibody is in worldwide phase III development with Roche and its subsidiaries, Genentech and Chugai Pharmaceutical, as well as Biogen Idec, for diffuse large B-cell lymphoma and non-Hodgkin's lymphoma generally, and is also in phase III development in countries outside of the US and EU for CLL.

  4. Pharmaceutical Industry in Syria

    PubMed Central

    2010-01-01

    The aim of this article is to present the development of the pharmaceutical industry in Syria using national and international public data sources. At the end of the 80ies, the pharmaceutical industry in Syria was very poor, covering 6% of the national needs. In less than 20 years, with the government support in terms of legal frame and strategic political engagement, the Syrian pharmaceutical industry finally covered almost 90% of the national needs, in terms of drugs, and exported drugs in around 52 Arabian countries. Beyond covering the local market, the main added values of this huge development consisted in exporting drugs in amount of 150 million dollars per year and providing jobs for 17000 Syrian people, out of which around 85% are women. Strong and weak points of the pharmaceutical sector are taken into consideration in the article and further interventions to support a sustainable development are proposed by the author. PMID:20945828

  5. The pharmaceutical industry: a further study in corporate power.

    PubMed

    McCraine, N; Murray, M J

    1978-01-01

    This article represents an updated version of previous research conducted on the United States pharmaceutical industry. The unstated purpose of this article is to present new findings which supplement the earlier research. This article describes three aspects of the United States pharmaceutical industry: its strategy and structure within the world market, its global expansion beyond the territorial boundaries of the United States, and its interlocking directorates with banking institutions. The thesis presented here is twofold: first, the United States pharmaceutical industry has become increasingly integrated into larger and more heterogeneous production units operating on the world market; and second, the United States pharmaceutical industry has become increasingly linked to large United States banking firms through interlocking directorates. PMID:730410

  6. Update on the botulinum neurotoxins.

    PubMed

    Carruthers, A; Carruthers, J

    2001-12-01

    The botulinum neurotoxins (BTX) are an exciting group of therapeutic agents with dramatically expanding clinical indications. The US FDA has approved BOTOX (BTX-A, Allergan) and Myobloc (BTX-B, Elan Pharmaceuticals) for the treatment of cervical dystonia. TPP Canada has also approved BOTOX for the treatment of glabellar frown lines. The US FDA is expected to approve this new indication before the end of 2002. These changes will dramatically expand the marketing of BTXs. Concerns about risks and side-effects diminish as clinical experience increases with this "most poisonous of poisons". In particular, the incidence of secondary resistance to the toxin's effect has been dramatically diminished with the reduction of the non-toxic protein in current batches of BOTOX. PMID:11813096

  7. Structural changes in the German pharmaceutical market: price setting mechanisms based on the early benefit evaluation.

    PubMed

    Henschke, Cornelia; Sundmacher, Leonie; Busse, Reinhard

    2013-03-01

    In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceutical company concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals. PMID:23339876

  8. Structural changes in the German pharmaceutical market: price setting mechanisms based on the early benefit evaluation.

    PubMed

    Henschke, Cornelia; Sundmacher, Leonie; Busse, Reinhard

    2013-03-01

    In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceutical company concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals.

  9. Bacterial mutagenicity screening in the pharmaceutical industry.

    PubMed

    Escobar, P A; Kemper, R A; Tarca, J; Nicolette, J; Kenyon, M; Glowienke, S; Sawant, S G; Christensen, J; Johnson, T E; McKnight, C; Ward, G; Galloway, S M; Custer, L; Gocke, E; O'Donovan, M R; Braun, K; Snyder, R D; Mahadevan, B

    2013-01-01

    Genetic toxicity testing is used as an early surrogate for carcinogenicity testing. Genetic toxicity testing is also required by regulatory agencies to be conducted prior to initiation of first in human clinical trials and subsequent marketing for most small molecule pharmaceutical compounds. To reduce the chances of advancing mutagenic pharmaceutical candidates through the drug discovery and development processes, companies have focused on developing testing strategies to maximize hazard identification while minimizing resource expenditure due to late stage attrition. With a large number of testing options, consensus has not been reached on the best mutagenicity platform to use or on the best time to use a specific test to aid in the selection of drug candidates for development. Most companies use a process in which compounds are initially screened for mutagenicity early in drug development using tests that require only a few milligrams of compound and then follow those studies up with a more robust mutagenicity test prior to selecting a compound for full development. This review summarizes the current applications of bacterial mutagenicity assays utilized by pharmaceutical companies in early and late discovery programs. The initial impetus for this review was derived from a workshop on bacterial mutagenicity screening in the pharmaceutical industry presented at the 40th Annual Environmental Mutagen Society Meeting held in St. Louis, MO in October, 2009. However, included in this review are succinct summaries of use and interpretation of genetic toxicity assays, several mutagenicity assays that were not presented at the meeting, and updates to testing strategies resulting in current state-of the art description of best practices. In addition, here we discuss the advantages and liabilities of many broadly used mutagenicity screening platforms and strategies used by pharmaceutical companies. The sensitivity and specificity of these early mutagenicity screening

  10. Legislative update.

    PubMed

    1999-04-01

    Updates are presented from nine States on HIV-related legislation. Legislative topics include HIV case surveillance, testing, corrections, safety of health-care workers, HIV status notification, the definition of disability, viatical settlements, and confidentiality breaches. PMID:11366638

  11. 75 FR 36301 - Review and Approval of Projects

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... final at 71 FR 78570, December 29, 2006, updating and expanding the range of projects subject to... Approval by Rule (ABR) natural gas pad site approvals issued under 18 CFR 806.22(f). However, ABRs issued... located. For applications to use public water supply a source for water in natural gas...

  12. 29 CFR 1956.70 - Description of plan as approved.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 9 2012-07-01 2012-07-01 false Description of plan as approved. 1956.70 Section 1956.70... Islands § 1956.70 Description of plan as approved. (a) The Virgin Islands State plan was converted to a... promulgated as of June 2003, and has given assurances that it will continue to adopt and update all...

  13. 29 CFR 1956.70 - Description of plan as approved.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Description of plan as approved. 1956.70 Section 1956.70... Islands § 1956.70 Description of plan as approved. (a) The Virgin Islands State plan was converted to a... promulgated as of June 2003, and has given assurances that it will continue to adopt and update all...

  14. Electronic Approval: Another Step toward a Paperless Office.

    ERIC Educational Resources Information Center

    Blythe, Kenneth C.; Morrison, Dennis L.

    1992-01-01

    Pennsylvania State University's award-winning electronic approval system allows administrative documents to be electronically generated, approved, and updated in the university's central database. Campus business can thus be conducted faster, less expensively, more accurately, and with greater security than with traditional paper approval…

  15. [Fourcroy and pharmaceutical journals].

    PubMed

    Bonnemain, Bruno

    2011-04-01

    Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.

  16. Improving environmental risk assessment of human pharmaceuticals.

    PubMed

    Ågerstrand, Marlene; Berg, Cecilia; Björlenius, Berndt; Breitholtz, Magnus; Brunström, Björn; Fick, Jerker; Gunnarsson, Lina; Larsson, D G Joakim; Sumpter, John P; Tysklind, Mats; Rudén, Christina

    2015-05-01

    This paper presents 10 recommendations for improving the European Medicines Agency's guidance for environmental risk assessment of human pharmaceutical products. The recommendations are based on up-to-date, available science in combination with experiences from other chemical frameworks such as the REACH-legislation for industrial chemicals. The recommendations concern: expanding the scope of the current guideline; requirements to assess the risk for development of antibiotic resistance; jointly performed assessments; refinement of the test proposal; mixture toxicity assessments on active pharmaceutical ingredients with similar modes of action; use of all available ecotoxicity studies; mandatory reviews; increased transparency; inclusion of emission data from production; and a risk management option. We believe that implementation of our recommendations would strengthen the protection of the environment and be beneficial to society. Legislation and guidance documents need to be updated at regular intervals in order to incorporate new knowledge from the scientific community. This is particularly important for regulatory documents concerning pharmaceuticals in the environment since this is a research field that has been growing substantially in the last decades.

  17. Analysis of the World Bank's pharmaceutical lending.

    PubMed

    Rodríguez-Monguió, Rosa; Rovira, Joan; Seoane-Vázquez, Enrique

    2007-04-01

    This article analyzes the World Bank's lending activity on pharmaceuticals and medical products (PMP) during the fiscal years (FY) 1999-2001 by regions, borrower and supplier country, and procurement method. Data for the study derived from the World Bank Project and the Business Warehouse databases. The information included all Bank projects approved during the study period. Information for the PMP procurement contracts was extracted for the health sector components of all sector projects awarded. Contract dollar amount was aggregated by borrower and supplier countries. A total of 365 contracts of PMP for a value of US$ 364.5 million (2001 prices) were awarded. International competitive bidding was the most common procurement method used representing 46.0% of the total PMP contracts amount. Domestic providers supplied 52.5% of the PMP contracts managed by the borrower countries. Twenty-two countries accounted for 97.0% of the total PMP purchased during the period of analysis. Only a small fraction of the Bank activity was directed to the pharmaceutical sector. There is a need for more involvement of the World Bank to increase accessibility, affordability and rational use of pharmaceuticals and medical products. An evaluation of the different procurement methods and their implications on drug quality and prices should be performed. PMID:16824640

  18. The extended pharmaceutical enterprise.

    PubMed

    Cavalla, David

    2003-03-15

    The availability of widespread contractual services led to the birth of the virtual company in the 1990s. As the concept has matured, and the biotechnology sector diversified, interchange of intellectual property in the form of collaborative and license arrangements opens up still further the opportunities for outsourced forms of pharmaceutical R&D. PMID:12623241

  19. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26405328

  20. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421525

  1. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421469

  2. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421484

  3. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25477570

  4. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25717211

  5. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421539

  6. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26823622

  7. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26448675

  8. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26405346

  9. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25673896

  10. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421513

  11. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    Abstract This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25477602

  12. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24715749

  13. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421565

  14. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-02-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421453

  15. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-11-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421440

  16. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-03-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421469

  17. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-04-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421484

  18. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-12-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24474838

  19. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-09-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421539

  20. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-10-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421552

  1. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-06-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421513

  2. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-07-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421525

  3. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421424

  4. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-05-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421499

  5. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2014-12-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25673896

  6. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2015-09-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26823622

  7. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2015-10-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26912923

  8. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25477618

  9. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26912923

  10. Thalidomide approved.

    PubMed

    1998-01-01

    The FDA has approved the use of Thalidomide (Thalomid) for treating a leprosy-associated condition. However, Thalidomide can also be used for HIV-related conditions if a physician prescribes it for "off-label use". In HIV-positive people, Thalidomide has been shown effective in treating mouth, throat, vaginal, and rectal ulcers, and has also been successful in clearing severe diarrhea-causing microsporidiosis infections. The FDA has also granted permission to use Thalidomide for treating AIDS-related wasting and mycobacterial infections by giving Thalidomide an "orphan drug status". Severe restrictions have been established for use of Thalidomide by women, because of the drug's association with birth defects. Contact information is provided.

  11. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate...

  12. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate...

  13. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate...

  14. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate...

  15. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate...

  16. Update '98.

    ERIC Educational Resources Information Center

    Mock, Karen R.

    1998-01-01

    Updates cases and issues previously discussed in this regular column on human rights in Canada, including racism and anti-Semitism, laws on hate crimes, hate sites on the World Wide Web, the use of the "free speech" defense by hate groups, and legal challenges to antiracist groups by individuals criticized by them. (DSK)

  17. EU pharmaceutical expenditure forecast

    PubMed Central

    Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    Background and Objectives With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Method In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012–2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. Results According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (−€9,367 million), France

  18. Patent term extensions: issues, challenges and implications for pharmaceuticals.

    PubMed

    Clark, Lisa; Beadle, Debbie

    2012-09-01

    The standard term of a patent is 20 years from the date of filing. However, the time required for a pharmaceutical product to pass through research and development, and clinical trials to obtain regulatory approval can often be more than 10 years. This effectively shortens the life of the patent leaving the patentee with little or no monopoly over the pharmaceutical product by the time it reaches market. The solution to this loss of patent monopoly in many countries is to provide an extension to compensate for loss of patent term due to obtaining regulatory approval of a product. This article provides a summary of some of the issues, challenges and implications of patent term extensions in various countries.

  19. Drugs Approved for Leukemia

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Leukemia This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Acute Lymphoblastic Leukemia (ALL) Abitrexate (Methotrexate) Arranon (Nelarabine) Asparaginase Erwinia chrysanthemi ...

  20. 75 FR 52467 - Approval and Promulgation of Air Quality Implementation Plans: Kentucky; Approval Section 110(a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ... updated ] emissions tables for this Area to reflect actual emissions. This plan meets the statutory and..., 1991 (56 FR 56694) because the Area did not meet the 1-hour ozone NAAQS. On November 13, 1992, the...). On February 7, 1995, EPA approved Kentucky's request to redesignate the Paducah Area (60 FR 7124)...

  1. 76 FR 5078 - Approval and Promulgation of Air Quality Implementation Plans: Tennessee; Approval of Section 110...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-28

    ... nonattainment for the 1-hour ozone NAAQS on November 6, 1991, 56 FR 56694 (effective January 6, 1992, 60 FR 7124... to attainment for the 1-hour ozone NAAQS (61 FR 55903). The maintenance plan for the Area became... approved Tennessee's maintenance plan update for the Nashville Area on November 1, 2005 (70 FR 65838)....

  2. Pharmaceutical spray freeze drying.

    PubMed

    Wanning, Stefan; Süverkrüp, Richard; Lamprecht, Alf

    2015-07-01

    Pharmaceutical spray-freeze drying (SFD) includes a heterogeneous set of technologies with primary applications in apparent solubility enhancement, pulmonary drug delivery, intradermal ballistic administration and delivery of vaccines to the nasal mucosa. The methods comprise of three steps: droplet generation, freezing and sublimation drying, which can be matched to the requirements given by the dosage form and route of administration. The objectives, various methods and physicochemical and pharmacological outcomes have been reviewed with a scope including related fields of science and technology.

  3. Trade, TRIPS, and pharmaceuticals.

    PubMed

    Smith, Richard D; Correa, Carlos; Oh, Cecilia

    2009-02-21

    The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus.

  4. Trade, TRIPS, and pharmaceuticals.

    PubMed

    Smith, Richard D; Correa, Carlos; Oh, Cecilia

    2009-02-21

    The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus. PMID:19167054

  5. Pharmaceutical product development: A quality by design approach.

    PubMed

    Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

  6. Pharmaceutical product development: A quality by design approach.

    PubMed

    Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

  7. Pharmaceutical product development: A quality by design approach

    PubMed Central

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

  8. Pharmaceutical product development: A quality by design approach

    PubMed Central

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

  9. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products

  10. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products PMID:27668042

  11. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    PubMed

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products. PMID:27668042

  12. Is the United States Still Dominant in the Global Pharmaceutical Innovation Network?

    PubMed Central

    Hu, Yuanjia; Scherngell, Thomas; Man, Si Nga; Wang, Yitao

    2013-01-01

    The dramatic growth of research and development activities in the pharmaceutical sector in emerging economies raises the question of whether the United States still keeps its dominant role in the global pharmaceutical innovation landscape. This paper focuses on investigating the role of the United States in global pharmaceutical innovation, and differs from previous studies by shifting attention to a network analytic perspective to track the global distribution of pharmaceutical inventions. Our sample is composed of key patents covering all new drugs approved by the Food and Drug Administration between 1996 and 2010. The results show that the United States still dominates in the global pharmaceutical innovation network, especially when it comes to essential core inventions. However, the United States shows a slightly decreasing prominence in the networks of either total new drugs or New Molecular Entity (NME) drugs in the time period 2006–2010 as compared to previous time periods, revealed by subtle traces of network centralities. PMID:24223710

  13. Micellar nanocarriers: pharmaceutical perspectives.

    PubMed

    Torchilin, V P

    2007-01-01

    Micelles, self-assembling nanosized colloidal particles with a hydrophobic core and hydrophilic shell are currently successfully used as pharmaceutical carriers for water-insoluble drugs and demonstrate a series of attractive properties as drug carriers. Among the micelle-forming compounds, amphiphilic copolymers, i.e., polymers consisting of hydrophobic block and hydrophilic block, are gaining an increasing attention. Polymeric micelles possess high stability both in vitro and in vivo and good biocompatibility, and can solubilize a broad variety of poorly soluble pharmaceuticals many of these drug-loaded micelles are currently at different stages of preclinical and clinical trials. Among polymeric micelles, a special group is formed by lipid-core micelles, i.e., micelles formed by conjugates of soluble copolymers with lipids (such as polyethylene glycol-phosphatidyl ethanolamine conjugate, PEG-PE). Polymeric micelles, including lipid-core micelles, carrying various reporter (contrast) groups may become the imaging agents of choice in different imaging modalities. All these micelles can also be used as targeted drug delivery systems. The targeting can be achieved via the enhanced permeability and retention (EPR) effect (into the areas with the compromised vasculature), by making micelles of stimuli-responsive amphiphilic block-copolymers, or by attaching specific targeting ligand molecules to the micelle surface. Immunomicelles prepared by coupling monoclonal antibody molecules to p-nitrophenylcarbonyl groups on the water-exposed termini of the micelle corona-forming blocks demonstrate high binding specificity and targetability. This review will discuss some recent trends in using micelles as pharmaceutical carriers. PMID:17109211

  14. [Adhesive cutaneous pharmaceutical forms].

    PubMed

    Gafiţanu, E; Matei, I; Mungiu, O C; Pavelescu, M; Mîndreci, I; Apostol, I; Ionescu, G

    1989-01-01

    The adhesive cutaneous pharmaceutical forms aimed to local action release the drug substance in view of a dermatological, traumatological, antirheumatic, cosmetic action. Two such preparations were obtained and their stability, consistency and pH were determined. The "in vitro" tests of their bioavailability revealed the dynamics of calcium ions release according to the associations of each preparation. The bioavailability determined by evaluating the pharmacological response demonstrated the antiinflammatory action obtained by the association of calcium ions with the components extracted from poplar muds. The therapeutical efficiency of the studied preparations has proved in the treatment of some sport injuries.

  15. Bolaamphiphiles: A Pharmaceutical Review

    PubMed Central

    Fariya, Mayur; Jain, Ankitkumar; Dhawan, Vivek; Shah, Sanket; Nagarsenker, Mangal S.

    2014-01-01

    The field of drug discovery is ever growing and excipients play a major role in it. A novel class of amphiphiles has been discussed in the review. The review focuses on natural as well as synthetic bolaamphiphiles, their chemical structures and importantly, their ability to self assemble rendering them of great use to pharmaceutical industry. Recent reports on their ability to be used in fabrication of suitable nanosized carriers for drug as well as genes to target site, has been discussed substantially to understand the potential of bolaamphiphiles in field of drug delivery. PMID:25671179

  16. Prospects for Anti-Biofilm Pharmaceuticals

    PubMed Central

    Stewart, Philip S.

    2015-01-01

    This commentary highlights several avenues currently being pursued in research labs to the development of new anti-biofilm pharmaceuticals. There is a real need for alternative therapeutic modalities for treating the persistent infections that sometimes form on implanted medical devices or compromised niches within the body. Strategies being researched include discovering new antimicrobial agents that kill microorganisms in biofilms more effectively than do existing antibiotics, designing drugs that block microbial adhesion or interfere with intercellular communication, developing chemistries to disperse biofilms, and combining agents with different mechanisms of action. Though the need is great, the pathway to commercialization of new drugs is steep. One possible streamlined approach to navigating the regulatory approval process is to repurpose old drugs, a strategy that a few groups have shown can yield agents with anti-biofilm properties. PMID:26343685

  17. Colloid update.

    PubMed

    Argalious, Maged Y

    2012-01-01

    This update aims to provide an evidence based review of natural and synthetic colloids with a special emphasis on the various generations of the synthetic colloid hydroxyethyl starch. The effect of 1(st), 2(nd) and 3(rd) generation hetastarches on bleeding, coagulopathy, acute kidney injury and mortality will be discussed. The results of randomised controlled trials addressing morbidity and mortality outcomes of colloid versus crystalloid resuscitation in critically ill patients will be described. In addition, the rationale and evidence behind early goal directed fluid therapy (EGDFT) including a practical approach to assessment of dynamic measures of fluid responsiveness will be presented.

  18. Rhabdomyolysis updated

    PubMed Central

    Efstratiadis, G; Voulgaridou, A; Nikiforou, D; Kyventidis, A; Kourkouni, E; Vergoulas, G

    2007-01-01

    Rhabdomyolysis constitutes a common cause of acute renal failure and presents paramount interest. A large variety of causes with different pathogenetic mechanisms can involve skeletal muscles resulting in rhabdomyolysis with or without acute renal failure. Crush syndrome, one of the most common causes of rhabdomyolysis presents increased clinical interest, particularly in areas often involved by earthquakes, such as Greece and Turkey. Drug abusers are another sensitive group of young patients prone to rhabdomyolysis, which attracts the clinical interest of a variety of medical specialties. We herein review the evidence extracted from updated literature concerning the data related to pathogenetic mechanisms and pathophysiology as well as the management of this interesting syndrome. PMID:19582207

  19. The Pharmaceutical Commons

    PubMed Central

    Lezaun, Javier

    2015-01-01

    In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of private property in this new configuration of global health research and development. Rather than a tool to block potential competitors, proprietary assets function as a lever to attract others into risky collaborative ventures; instead of demarcating public and private domains, the sharing of property rights is used to increase the porosity of that boundary. This reimagination of the value of property is connected to the peculiar timescape of global health drug development, a promissory orientation to the future that takes its clearest form in the centrality of “virtual” business models and the proliferation of strategies of deferral. Drawing on the anthropological literature on inalienable possessions, we reconsider property’s traditional exclusionary role and discuss the possibility that the new pharmaceutical “commons” proclaimed by contemporary global health partnerships might be the precursor of future enclosures. PMID:25866425

  20. Mipomersen sodium: first global approval.

    PubMed

    Hair, Philip; Cameron, Fiona; McKeage, Kate

    2013-04-01

    Mipomersen sodium (Kynamro™) (henceforth mipomersen) is a second-generation antisense oligonucleotide inhibitor of apolipoprotein B-100, which is the main structural component of atherogenic lipid particles. Mipomersen is administered via subcutaneous injection and is indicated as adjunctive treatment for homozygous familial hypercholesterolaemia (HoFH). The drug was developed by Isis Pharmaceuticals, which now collaborates with Genzyme Corporation for on-going development and product marketing. Multinational phase III trials of mipomersen as adjunctive therapy were completed in patients with HoFH, severe FH, heterozygous FH (HeFH) with coronary artery disease (CAD), and in those with hypercholesterolaemia at high risk of CAD. Mipomersen 200 mg once weekly has been approved in the USA as an adjunct to lipid-lowering medications and diet in HoFH patients and is undergoing regulatory review in the EU for the same indication. Genzyme is also conducting a multinational phase III, open-label extension study to evaluate long-term treatment in HoFH and HeFH patients, as well as a multinational trial to evaluate a three-times-per-week mipomersen regimen in patients with severe FH. This article summarises the milestones in the development of once-weekly, subcutaneous mipomersen leading to this first approval.

  1. Mipomersen sodium: first global approval.

    PubMed

    Hair, Philip; Cameron, Fiona; McKeage, Kate

    2013-04-01

    Mipomersen sodium (Kynamro™) (henceforth mipomersen) is a second-generation antisense oligonucleotide inhibitor of apolipoprotein B-100, which is the main structural component of atherogenic lipid particles. Mipomersen is administered via subcutaneous injection and is indicated as adjunctive treatment for homozygous familial hypercholesterolaemia (HoFH). The drug was developed by Isis Pharmaceuticals, which now collaborates with Genzyme Corporation for on-going development and product marketing. Multinational phase III trials of mipomersen as adjunctive therapy were completed in patients with HoFH, severe FH, heterozygous FH (HeFH) with coronary artery disease (CAD), and in those with hypercholesterolaemia at high risk of CAD. Mipomersen 200 mg once weekly has been approved in the USA as an adjunct to lipid-lowering medications and diet in HoFH patients and is undergoing regulatory review in the EU for the same indication. Genzyme is also conducting a multinational phase III, open-label extension study to evaluate long-term treatment in HoFH and HeFH patients, as well as a multinational trial to evaluate a three-times-per-week mipomersen regimen in patients with severe FH. This article summarises the milestones in the development of once-weekly, subcutaneous mipomersen leading to this first approval. PMID:23564617

  2. Document Update and Compare

    NASA Technical Reports Server (NTRS)

    Knoch, C. F.; Caldwell, D. C.; Caldwell, D. L.

    1983-01-01

    Document Update and Compare programs provide simple computerized documentmaintenance system on Data General NOVA 840 computer. Document Update program allows user to update document either by batch or terminal input. Documents are modified and lists of modifications printed out.

  3. Pharmaceutical study of Yashadabhasma

    PubMed Central

    Bhojashettar, Santhosh; Jadar, P. G.; Rao, V. Nageswara

    2012-01-01

    Background: Rasashastra is a branch which deals with the pharmaceutics of Rasaoushadhis. Bhasmas are one among such Rasaoushadhis which are known for their low doses and fast action. A verse from Rasaratnasamuchchaya says that the bhasma prepared by using Mercury as media is of best quality. Materials and Methods: Following this principle, Yashadabhasma (Zinc calx) was prepared by subjecting it to Samanya shodhana (general purification method for all metals), Vishesha shodhana (specific putification method for Zinc), Jarana (roasting) and Marana (incineration) with Parada(Mercury) as a media under Gajaputa (classical heating system with 1000 cowdung cakes). Results and Conclusion: Yellow colored Yashadabhasma which passed all the classical bhasmaparikshas (tests for properly prepared calx) was obtained after two putas. The bhasma did not pass Nishchandratva(free from shining particles) test after 1stputa but was passed after giving it 2ndputa. PMID:23284213

  4. [Pharmacovigilance update].

    PubMed

    Diezi, Léonore; Renard, Delphine; Rothuizen, Laura E; Livio, Françoise

    2014-01-15

    The main pharmacovigilance updates in 2013 are reviewed. Nitrofurantoin: lower efficacy and an increased risk of adverse events when creatinine clearance is below 60 ml/min. Dabigatran: contraindicated in patients with mechanical heart valves. Azithromycin: QT prolongation and increased risk of death. Zolpidem: towards a lower dosage. Roflumilast: avoid in patients known or at risk for mood disorders. Retigabine: indication restricted to last-line use and new monitoring requirements after reports of pigment changes in retina and other tissues. Telaprevir and rituximab: severe mucocutaneous reactions. Fingolimod: rare cases of progressive multifocal leucoencephalopathy. Tolvaptan: potential for hepatotoxicity. Nicotinic acid/laropiprant: suspension of marketing authorization as benefits no longer outweigh risks. PMID:24558915

  5. Methuselah's medicine: pharmaceutical innovation and mortality in the United States, 1960-2000.

    PubMed

    Schnittker, Jason; Karandinos, George

    2010-04-01

    Although there is a good deal of speculation surrounding the role of pharmaceutical innovation in late 20th century mortality improvements in the United States, there is little empirical evidence on the topic and there remains a good deal of doubt regarding whether pharmaceuticals matter at all for mortality. Using a reliable indicator of pharmaceutical innovation-yearly approvals of new molecular entities (NMEs) by the Food and Drug Administration, along with information on priority status and disease-category indication-this study examines the relationship between pharmaceutical innovation and life expectancy between 1960 and 2000. The study demonstrates a significant relationship between pharmaceutical innovation and life expectancy at birth, which is robust to controls for gross domestic product, as well as controls for various forms of medical spending. The relationship with life expectancy is robust, in part, because pharmaceutical innovation has a stronger relationship with early-life mortality (between 20 and 50) than with later-life mortality (65 and over), even though older persons consume more pharmaceuticals and many recently approved drugs target conditions more common in later life. There is, to be sure, another side to the results. There is some evidence, for example, that the relationship between pharmaceutical innovation and mortality has declined over time, suggesting a change in the kind of innovations now entering the market. Nevertheless, there is more to contemporary pharmaceutical innovation than the development of mere "halfway" technologies. The overall relationship between innovation and mortality is sufficiently strong to warrant further consideration as a key determinant of trends in mortality.

  6. Pharmaceutical Company Corruption and the Moral Crisis in Medicine.

    PubMed

    Batt, Sharon

    2016-07-01

    A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics "pharmascolds." Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. PMID:27417863

  7. Pharmaceutical Company Corruption and the Moral Crisis in Medicine.

    PubMed

    Batt, Sharon

    2016-07-01

    A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics "pharmascolds." Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative.

  8. Radium-223 Therapy for Patients with Metastatic Castrate-Resistant Prostate Cancer: An Update on Literature with Case Presentation

    PubMed Central

    Appleman, Leonard J.; Mountz, James M.

    2016-01-01

    Background and Purpose. Radium-223 dichloride (Xofigo®, Bayer HealthCare Pharmaceuticals Inc.) is the first α-particle emitter therapeutic agent approved by the FDA, with benefits in overall survival and delay in symptomatic skeletal event for patients with metastatic castrate-resistant prostate cancer (CRPC). Recent post hoc analyses of the phase III ALSYMPCA trial support the previously established safety profile as well as therapeutic effect and clinical outcome of Radium-223. Currently, Radium-223 is approved as a single agent therapy for metastatic CRPC. Clinical trials are currently investigating Radium-223 in additional clinical settings such as earlier asymptomatic disease and in combination with other agents including hormonal therapeutic agents and immunotherapeutic as well as chemotherapeutic agents. Trials are also ongoing in patients with other primary cancers such as breast cancer, thyroid cancer, and renal cancer metastatic to bone. In this article, the physics and radiobiology, as well as a literature update on the use of Radium-223, are provided along with case presentations, aiming at a better appreciation of research data as well as the assimilation of research data into clinical practice. PMID:27774318

  9. Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

    PubMed Central

    Chollet, John L.; Jozwiakowski, Michael J.

    2012-01-01

    The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865

  10. Reducing pharmaceutical risk.

    PubMed

    Spilker, B

    1998-08-01

    This article describes several types of risk encountered in drug discovery, development and marketing, as well as the overall business risks in the pharmaceutical industry. Discovery risk refers to the risk companies face if they are partly or totally dependent on discovering new drugs; many avenues are presented for companies to pursue in order to decrease discovery risk. Development risk is defined as the risk that drug discoveries that enter development will not reach the market and become commercially viable drugs. To decrease development risk, it is possible to pursue one or more of the approaches presented. Significant marketing risks for a company include that the sales forecasts will not be met, the positioning of a drug may not be correct or optimal and the sales force is not performing adequately. At the corporate level there are numerous major risks involved in pursuing the specific mission, objectives, strategies and tactics of the overall company as well as those in the functional areas. Many aspects of the company's business can be adjusted or changed to decrease corporate risk. Selected issues concerning risk include venture capital funds, the appetite for risk within a company and the influence of senior and middle level managers' personalities on risk.

  11. Pharmaceutical prospects of phytoestrogens.

    PubMed

    Usui, Takeshi

    2006-02-01

    Interest in the physiologic and pharmacologic role of bioactive compounds present in plants has increased dramatically over the last decade. Of particular interest in relation to human health are the classes of compounds known as the phytoestrogens, which embody several groups of non-steroidal estrogens, including isoflavones and lignans that are widely distributed within nature. The impact of dietary phytoestrogens on normal biologic processes was first recognized in sheep. Observations of sheep grazing on fields rich in clover and cheetahs fed high soy diets in zoos suggested that flavonoids and related phytochemicals can affect mammalian health. Endogenous estrogens have an important role not only in the hypothalamic-pituitary-gonadal axis, but also in various non-gonadal systems, such as cardiovascular systems, bone, and central nervous systems, and lipid metabolism. There have been several clinical studies of hormone replacement therapy (HRT) in post-menopausal women to examine whether HRT has beneficial effects on the cardiovascular system, bone fractures, lipid metabolism, and Alzheimer's disease. In addition, estrogen contributes to the development of some estrogen-dependent cancers, such as breast cancer and prostate cancer and the number of patients with these cancers is increasing in developed countries. Although recent mega-studies showed negative results for classical HRT in the prevention of some of these diseases, the molecules that interact with estrogen receptors are candidate drugs for various diseases, including hormone-dependent cancers. This review focuses on the molecular properties and pharmaceutical potential of phytoestrogens.

  12. Reducing pharmaceutical risk.

    PubMed

    Spilker, B

    1998-08-01

    This article describes several types of risk encountered in drug discovery, development and marketing, as well as the overall business risks in the pharmaceutical industry. Discovery risk refers to the risk companies face if they are partly or totally dependent on discovering new drugs; many avenues are presented for companies to pursue in order to decrease discovery risk. Development risk is defined as the risk that drug discoveries that enter development will not reach the market and become commercially viable drugs. To decrease development risk, it is possible to pursue one or more of the approaches presented. Significant marketing risks for a company include that the sales forecasts will not be met, the positioning of a drug may not be correct or optimal and the sales force is not performing adequately. At the corporate level there are numerous major risks involved in pursuing the specific mission, objectives, strategies and tactics of the overall company as well as those in the functional areas. Many aspects of the company's business can be adjusted or changed to decrease corporate risk. Selected issues concerning risk include venture capital funds, the appetite for risk within a company and the influence of senior and middle level managers' personalities on risk. PMID:15616620

  13. Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation?

    PubMed

    Arnold, Denis G; Troyer, Jennifer L

    2016-04-01

    The pharmaceutical industry has been criticized for developing and aggressively marketing drugs that do not provide significant health benefits relative to existing drugs but retain the benefits of patent protection. Critics argue that drug marketing increases health care expenditures and provides a disincentive for pioneering drug innovation. However, evidence that marketing expenditures have any relationship to new drug approvals has been anecdotal. We hypothesized that, at publicly traded pharmaceutical firms, increased marketing expenditures will result in a reduced volume of pioneering new drugs in comparison to less innovative new drugs. We also hypothesized that additional research and development spending will result in an increased volume of pioneering new drugs in comparison to less innovative drugs. Results confirm our hypotheses. Specific policy recommendations for altering firms' incentives for the development of pioneering drugs are provided.

  14. Economic aspects of the new Spanish laws on pharmaceutical preparations.

    PubMed

    Antoñanzas, Fernando; Oliva, Juan; Pinillos, Mariola; Juàrez, Carmelo

    2007-09-01

    In this article, we provide readers with a summary of the main economic features of the recently approved Spanish law regarding pharmaceutical preparations entitled the Law of Guarantees and Rational Use of Pharmaceuticals and Health Products (Law 29/2006 of July 26th). We review information on pricing, reference pricing, promotion of generic drugs, public reimbursement, patients' contributions, and penalties. Other aspects of minor economic relevance such as the information on prices shown in the packs and the transparency on the results of clinical trials irrespective of whether these are positive or not, are not addressed in this paper. We conclude with some observations on the new horizons opened up by this new legal framework. We have not included any detailed references to the new law; we merely wish to comment on certain aspects of its application.

  15. Prioritizing pharmaceuticals in municipal wastewater

    EPA Science Inventory

    Oral presentation at SETAC North America 32nd annual meeting, describing our prioritization of active pharmaceutical ingredients (APIs), based on estimates of risks posed by API residues originating from municipal wastewater. Goals of this project include prioritization of APIs f...

  16. Recognizing misleading pharmaceutical marketing online.

    PubMed

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2014-01-01

    In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences.

  17. Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.

    PubMed

    Nagai, Sumimasa; Ozawa, Keiya

    2016-07-01

    The Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare in Japan and the US Food and Drug Administration are responsible for reviewing applications and approving drugs, medical devices, and regenerative medicines. In the EU, the European Medicines Agency is responsible for the centralized authorization procedure of medicines including oncologic drugs. In this review, we discuss general pathways for the marketing authorization of oncologic drugs and other drugs in Japan, the EU, and the US. There are still unmet medical needs in oncology, whereas scientific innovation and clinical development in oncology are rapid and active, suggesting a reasonable scope for new regulatory schemes for expedited review. Because regulatory schemes are also evolving rapidly, clinicians and academic researchers may have difficulty following the updated regulations in other regions as well as those in their own countries. However, keeping current with new regulations is important for the conduct of translational research and clinical development of new therapeutic products efficiently. This review is intended to help an international audience better understand the essence of the regulatory frameworks for the marketing authorization of oncologic drugs in Japan, the EU, and the US.

  18. What drives success for specialty pharmaceuticals?

    PubMed

    Gudiksen, Mark; Fleming, Edd; Furstenthal, Laura; Ma, Philip

    2008-07-01

    Specialty pharmaceuticals have become increasingly important in the global pharmaceutical landscape. Numerous large pharmaceutical companies are moving towards developing therapies for specialty markets, which are attractive owing to factors including the established commercial track record and lower commercial infrastructure costs. In this article, we analyse the key drivers of commercial success and failure for specialty pharmaceuticals.

  19. [Pharmaceutical chemistry of general anaesthetics].

    PubMed

    Szász, György; Takácsné, Novák Krisztina

    2004-01-01

    The paper represents the first part of a planned series of reviews about pharmaceutical chemistry of drugs acting on the central nervous system. The authorial aim and editorial concepts are the same were followed in a former series of papers about pharmaceutical chemistry of agents effecting the heart, blood circulation and vegetative nervous system. Consequently, general anaesthetics are discussed in the present paper through the chapters "history, preparation; structure-properties-activity; application; analysis".

  20. FDA-approved small-molecule kinase inhibitors.

    PubMed

    Wu, Peng; Nielsen, Thomas E; Clausen, Mads H

    2015-07-01

    Kinases have emerged as one of the most intensively pursued targets in current pharmacological research, especially for cancer, due to their critical roles in cellular signaling. To date, the US FDA has approved 28 small-molecule kinase inhibitors, half of which were approved in the past 3 years. While the clinical data of these approved molecules are widely presented and structure-activity relationship (SAR) has been reported for individual molecules, an updated review that analyzes all approved molecules and summarizes current achievements and trends in the field has yet to be found. Here we present all approved small-molecule kinase inhibitors with an emphasis on binding mechanism and structural features, summarize current challenges, and discuss future directions in this field.

  1. 78 FR 76389 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... of Projects Approved for Collection and Use: PFC audit costs, 2001 through 2011. Master plan and... taxi lane improvements (engineering/design). Master plan update. Acquire snow removal equipment (two... reconstruction. Master plan update. Rehabilitate terminal apron. Passenger loading bridge. Wildlife...

  2. 7 CFR 1710.205 - Minimum approval requirements for all load forecasts.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... electronically to RUS computer software applications. RUS will evaluate borrower load forecasts for readability... forecast or an update of an approved load forecast as loan support, the borrower must demonstrate that the... required to coordinate preparation of their respective load forecasts, updates of load forecasts,...

  3. 7 CFR 1710.205 - Minimum approval requirements for all load forecasts.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... electronically to RUS computer software applications. RUS will evaluate borrower load forecasts for readability... forecast or an update of an approved load forecast as loan support, the borrower must demonstrate that the... required to coordinate preparation of their respective load forecasts, updates of load forecasts,...

  4. 7 CFR 1710.205 - Minimum approval requirements for all load forecasts.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... electronically to RUS computer software applications. RUS will evaluate borrower load forecasts for readability... forecast or an update of an approved load forecast as loan support, the borrower must demonstrate that the... required to coordinate preparation of their respective load forecasts, updates of load forecasts,...

  5. The cultural shift in Italy's pharmaceutical policy in 1994: a case history.

    PubMed

    Garattini, Silvio

    2004-01-01

    The advent of the National Health Service in 1978 in Italy also resulted in the compilation of a formulary of pharmaceutical products to be distributed free of charge. During the subsequent years the formulary increased in size with the introduction of new drugs and consequently pharmaceutical expenses increased steadily, reaching a peak in 1992. The years preceding this peak of expenses were characterized by pervasive corruption that involved several government civil servants and even the Minister of Health, as well as several members of the national committees responsible for the approval and pricing of medicinal products. The present article summarizes the events from 1992 in Italy when the revelation of corruption in the healthcare system and the pressure of public opinion obliged the authorities to make drastic changes in the pharmaceutical policy, and also introduces and discusses the reactions and the impact of such changes on pharmaceutical expenses and drug utilization over the following years.

  6. Innovation in the pharmaceutical industry: New estimates of R&D costs.

    PubMed

    DiMasi, Joseph A; Grabowski, Henry G; Hansen, Ronald W

    2016-05-01

    The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development. The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per approved new compound is $1395 million (2013 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 10.5% yields a total pre-approval cost estimate of $2558 million (2013 dollars). When compared to the results of the previous study in this series, total capitalized costs were shown to have increased at an annual rate of 8.5% above general price inflation. Adding an estimate of post-approval R&D costs increases the cost estimate to $2870 million (2013 dollars). PMID:26928437

  7. Innovation in the pharmaceutical industry: New estimates of R&D costs.

    PubMed

    DiMasi, Joseph A; Grabowski, Henry G; Hansen, Ronald W

    2016-05-01

    The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development. The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per approved new compound is $1395 million (2013 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 10.5% yields a total pre-approval cost estimate of $2558 million (2013 dollars). When compared to the results of the previous study in this series, total capitalized costs were shown to have increased at an annual rate of 8.5% above general price inflation. Adding an estimate of post-approval R&D costs increases the cost estimate to $2870 million (2013 dollars).

  8. Elemental Impurities in Pharmaceutical Excipients.

    PubMed

    Li, Gang; Schoneker, Dave; Ulman, Katherine L; Sturm, Jason J; Thackery, Lisa M; Kauffman, John F

    2015-12-01

    Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by a lack of publically available information on elemental impurity levels in common pharmaceutical excipients. This paper summarizes a recent survey of elemental impurity levels in common pharmaceutical excipients as well as some drug substances. A widely applicable analytical procedure was developed and was shown to be suitable for analysis of elements that are subject to United States Pharmacopoeia Chapter <232> and International Conference on Harmonization's Q3D Guideline on Elemental Impurities. The procedure utilizes microwave-assisted digestion of pharmaceutical materials and inductively coupled plasma mass spectrometry for quantitative analysis of these elements. The procedure was applied to 190 samples from 31 different excipients and 15 samples from eight drug substances provided through the International Pharmaceutical Excipient Council of the Americas. The results of the survey indicate that, for the materials included in the study, relatively low levels of elemental impurities are present. PMID:26398581

  9. Elemental Impurities in Pharmaceutical Excipients.

    PubMed

    Li, Gang; Schoneker, Dave; Ulman, Katherine L; Sturm, Jason J; Thackery, Lisa M; Kauffman, John F

    2015-12-01

    Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by a lack of publically available information on elemental impurity levels in common pharmaceutical excipients. This paper summarizes a recent survey of elemental impurity levels in common pharmaceutical excipients as well as some drug substances. A widely applicable analytical procedure was developed and was shown to be suitable for analysis of elements that are subject to United States Pharmacopoeia Chapter <232> and International Conference on Harmonization's Q3D Guideline on Elemental Impurities. The procedure utilizes microwave-assisted digestion of pharmaceutical materials and inductively coupled plasma mass spectrometry for quantitative analysis of these elements. The procedure was applied to 190 samples from 31 different excipients and 15 samples from eight drug substances provided through the International Pharmaceutical Excipient Council of the Americas. The results of the survey indicate that, for the materials included in the study, relatively low levels of elemental impurities are present.

  10. 76 FR 60961 - Approval of Noise Compatibility Program; Kissimmee Gateway Airport, Kissimmee, FL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... procedures for noise control). Failure to approve or disapprove such Program within the 180-day period shall... Federal Aviation Administration Approval of Noise Compatibility Program; Kissimmee Gateway Airport... Administration (FAA) announces its findings on the Noise Compatibility Program Update (NCP) submitted by the...

  11. 78 FR 36560 - 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal, Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal...: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th... Title of Information Collection: FHA Lender Approval, Annual Renewal, Periodic Updates and...

  12. 10 CFR 851.11 - Development and approval of worker safety and health program.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of DOE Field Element, for review and approval whenever a significant change or addition to the program is made, or a change in contractors occurs. (2) Contractors must submit annually to DOE either an updated worker safety and health program for approval or a letter stating that no changes are necessary...

  13. 78 FR 17937 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of...: Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street SW., Washington,...

  14. 75 FR 12251 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of... Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410; e-mail...

  15. 76 FR 34091 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-10

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of...: Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street, SW., Washington,...

  16. 77 FR 63323 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-16

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of...: Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street SW., Washington,...

  17. 78 FR 18364 - Electronic Prescriptions for Controlled Substances Notice of Approved Certification Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... FR 16236-16319, and became effective on June 1, 2010. Update Certifying Organizations With a... posted on DEA's Web site. 75 FR 16243 (March 31, 2010). On January 18, 2013, DEA approved the... biometrics subsystem, including its interfaces. 77 FR 45688 (August 1, 2012). This approval for...

  18. Proposed Plan for Adopting Updated Range Reference Atmospheres

    NASA Technical Reports Server (NTRS)

    Keller, Vernon; Burns, Lee

    2004-01-01

    The Terrestrial and Planetary Environments Team at Marshall Space Flight Center (MSFC) proposes to facilitate validation, documentation, and adoption of updated Range Reference Atmospheres (RRAs). This viewgraph presentation describes the plan, focusing on seven tasks: 1) Document data sources; 2) Document analytical models; 3) Document data processing procedures; 4) Compare updates to 1983 versions; 5) Compile written documentation; 6) Obtain approval for final volumes; 7) Publish new RRA datasets/documents.

  19. Bexarotene ligand pharmaceuticals.

    PubMed

    Hurst, R E

    2000-12-01

    Bexarotene (LGD-1069), from Ligand, was the first retinoid X receptor (RXR)-selective, antitumor retinoid to enter clinical trials. The company launched the drug for the treatment of cutaneous T-cell lymphoma (CTCL), as Targretin capsules, in the US in January 2000 [359023]. The company filed an NDA for Targretin capsules in June 1999, and for topical gel in December 1999 [329011], [349982] specifically for once-daily oral administration for the treatment of patients with early-stage CTCL who have not tolerated other therapies, patients with refractory or persistent early stage CTCL and patients with refractory advanced stage CTCL. The FDA approved Targretin capsules at the end of December 1999 for once-daily oral treatment of all stages of CTCL in patients refractory to at least one prior systemic therapy, at an initial dose of 300 mg/m2/day. After an NDA was submitted in December 1999 for Targretin gel, the drug received Priority Review status for use as a treatment of cutaneous lesions in patients with stage IA, IB or IIA CTCL [354836]. The FDA issued an approvable letter in June 2000, and granted marketing clearance for CTCL in the same month [370687], [372768], [372769], [373279]. Ligand had received Orphan Drug designation for this indication [329011]. At the request of the FDA, Ligand agreed to carry out certain post-approval phase IV and pharmacokinetic studies [351604]. The company filed an MAA with the EMEA for Targretin Capsules to treat lymphoma in November 1999 [348944]. The NDA for Targretin gel is based on a multicenter phase III trial that was conducted in the US, Canada, Europe and Australia involving 50 patients and a multicenter phase I/II clinical program involving 67 patients. Targretin gel was evaluated for the treatment of patients with early stage CTCL (IA-IIA) who were refractory to, intolerant to, or reached a response plateau for at least 6 months on at least two prior therapies. Efficacy results exceeded the protocol-defined response

  20. A vision of the pharmaceutical industry.

    PubMed

    Muñio, S

    1998-01-01

    As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing.

  1. ISIS-3521. Isis Pharmaceuticals.

    PubMed

    Li, K; Zhang, J

    2001-10-01

    ISIS-3521 is a 20-mer antisense phosphorothioate oligonucleotide PKCa expression inhibitor, under development by Isis (formerly in collaboration with Novartis) for the potential treatment of solid tumors that are refractory to, or recurrent with, standard treatment regimens [175741]. In November 1999, Novartis announced that it would end its codevelopment of ISIS-3521 [348221], [348222]. In August 2001, Eli Lilly in-licensed ISIS-3521 [420062]. In October 2000, phase III trials of ISIS-3521, in combination with carboplatin and paclitaxel, were initiated for the treatment of non-small cell lung cancer (NSCLC) [386128]. The FDA granted ISIS-3521 Fast Track review status for NSCLC in November 2000 [388930]. In April 2001, Bear Sterns & Co predicted US approval of ISIS-3521 in 2002 [411081]. In August 2001, Eli Lilly and Isis entered into a four-year strategic alliance that includes ISIS-3521. For the license of ISIS-3521, Isis will receive $25 million in upfront fees and will be reimbursed for remaining phase III development and registration costs [420062].

  2. Virtual pharmaceutical companies: collaborating flexibly in pharmaceutical development.

    PubMed

    Forster, Simon P; Stegmaier, Julia; Spycher, Rene; Seeger, Stefan

    2014-03-01

    Research and development (R&D) collaborations represent one approach chosen by the pharmaceutical industry to tackle current challenges posed by declining internal R&D success rates and fading of the blockbuster model. In recent years, a flexible concept to collaborate in R&D has emerged: virtual pharmaceutical companies (VPCs). These differ from other R&D companies, such as biotech start-ups, collaborating with big pharmaceutical companies, because they solely comprise experienced teams of managers. VPCs have only been described anecdotally in literature. Thus, we present here the characteristics of a VPC and suggest how big pharma can leverage the concept of VPCs by introducing five possible modes of collaboration. We find that one mode, investing, is particularly promising for big pharma. PMID:24291787

  3. Virtual pharmaceutical companies: collaborating flexibly in pharmaceutical development.

    PubMed

    Forster, Simon P; Stegmaier, Julia; Spycher, Rene; Seeger, Stefan

    2014-03-01

    Research and development (R&D) collaborations represent one approach chosen by the pharmaceutical industry to tackle current challenges posed by declining internal R&D success rates and fading of the blockbuster model. In recent years, a flexible concept to collaborate in R&D has emerged: virtual pharmaceutical companies (VPCs). These differ from other R&D companies, such as biotech start-ups, collaborating with big pharmaceutical companies, because they solely comprise experienced teams of managers. VPCs have only been described anecdotally in literature. Thus, we present here the characteristics of a VPC and suggest how big pharma can leverage the concept of VPCs by introducing five possible modes of collaboration. We find that one mode, investing, is particularly promising for big pharma.

  4. Chemistry in the Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

  5. An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.

    PubMed

    Lanthier, Michael; Miller, Kathleen L; Nardinelli, Clark; Woodcock, Janet

    2013-08-01

    For more than a decade, industry analysts and policy makers have raised concerns about declining pharmaceutical innovation, citing declining numbers of new molecular entities (NMEs) approved in the United States each year. Yet there is little consensus on whether this is the best measure of "innovation." We examined NME approvals during 1987-2011 and propose the three distinct subcategories of NMEs--first-in-class, advance-in-class, and addition-to-class--to provide more nuanced and informative insights into underlying trends. We found that trends in NME approvals were largely driven by addition-to-class, or "me too," drug approvals, while first-in-class approvals remained fairly steady over the study period. Moreover, the higher proportion of first-in-class drug approvals over the most recent decade is an encouraging sign of the health of the industry as a whole.

  6. The World Bank and pharmaceuticals.

    PubMed

    Falkenberg, T; Tomson, G

    2000-03-01

    Within less than a decade the World Bank has become the largest single source of finance (loans) for health in low and middle income countries as well as a major player in the field of pharmaceuticals. Often 20-50% of the recurrent government health budget in developing countries is used to procure drugs. Drugs are among the most salient and cost-effective elements of health care and often a key factor for the success of a health sector reform. However, pharmaceuticals are frequently being used irrationally, mainly due to market imperfections in health care, such as information asymmetries, leading to serious health problems and a heavy financial burden on the health system. Lending priorities set by the World Bank could be used to promote public health sector reform, leading to the rational use of affordable and available drugs of good quality in developing countries. This report provides the first analysis of World Bank activity in the pharmaceutical sector worldwide. The analysis of 77 staff appraisal reports, describing the planning phase of World Bank country projects, shows that 16% of the total World Bank health, nutrition and population budget, or approximately US$1.3 billion, has been committed to loans or credits supporting pharmaceutical activities in the programme countries between 1989-95. Roughly US$1.05 billion has been committed to procurement of drugs and medical equipment. Only 5% of the total pharmaceutical sector lending is committed to software components such as drug policy work and rational use of drugs. No more than 45% of the projects were developed in collaboration with pharmaceutical expertise. The World Bank is recommended to improve its pharmaceutical sector involvement by promoting drug policy research and development including national and international dialogue on pharmaceutical issues to ensure rational use of both drugs and loans. In this, the World Bank has an advantage given its experience from working with both the private and

  7. The World Bank and pharmaceuticals.

    PubMed

    Falkenberg, T; Tomson, G

    2000-03-01

    Within less than a decade the World Bank has become the largest single source of finance (loans) for health in low and middle income countries as well as a major player in the field of pharmaceuticals. Often 20-50% of the recurrent government health budget in developing countries is used to procure drugs. Drugs are among the most salient and cost-effective elements of health care and often a key factor for the success of a health sector reform. However, pharmaceuticals are frequently being used irrationally, mainly due to market imperfections in health care, such as information asymmetries, leading to serious health problems and a heavy financial burden on the health system. Lending priorities set by the World Bank could be used to promote public health sector reform, leading to the rational use of affordable and available drugs of good quality in developing countries. This report provides the first analysis of World Bank activity in the pharmaceutical sector worldwide. The analysis of 77 staff appraisal reports, describing the planning phase of World Bank country projects, shows that 16% of the total World Bank health, nutrition and population budget, or approximately US$1.3 billion, has been committed to loans or credits supporting pharmaceutical activities in the programme countries between 1989-95. Roughly US$1.05 billion has been committed to procurement of drugs and medical equipment. Only 5% of the total pharmaceutical sector lending is committed to software components such as drug policy work and rational use of drugs. No more than 45% of the projects were developed in collaboration with pharmaceutical expertise. The World Bank is recommended to improve its pharmaceutical sector involvement by promoting drug policy research and development including national and international dialogue on pharmaceutical issues to ensure rational use of both drugs and loans. In this, the World Bank has an advantage given its experience from working with both the private and

  8. Chapter A5. Section 6.1.F. Wastewater, Pharmaceutical, and Antibiotic Compounds

    USGS Publications Warehouse

    Lewis, Michael Edward; Zaugg, Steven D.

    2003-01-01

    The USGS differentiates between samples collected for analysis of wastewater compounds and those collected for analysis of pharmaceutical and antibiotic compounds, based on the analytical schedule for the laboratory method. Currently, only the wastewater laboratory method for field-filtered samples (SH1433) is an approved, routine (production) method. (The unfiltered wastewater method LC 8033 also is available but requires a proposal for custom analysis.) At this time, analysis of samples for pharmaceutical and antibiotic compounds is confined to research studies and is available only on a custom basis.

  9. Savannah River Site Approved Site Treatment Plan, 1998 Annual Update

    SciTech Connect

    Lawrence, B.

    1999-04-20

    The Compliance Plan Volume (Volume I) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions. Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume II) and is provided for information.

  10. Savannah River Site approved site treatment plan, 2000 annual update

    SciTech Connect

    Lawrence, B.

    2000-04-20

    The Compliance Plan Volume (Volume 1) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions. Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume 2) and is provided for information.

  11. The odyssey of marine pharmaceuticals: a current pipeline perspective.

    PubMed

    Mayer, Alejandro M S; Glaser, Keith B; Cuevas, Carmen; Jacobs, Robert S; Kem, William; Little, R Daniel; McIntosh, J Michael; Newman, David J; Potts, Barbara C; Shuster, Dale E

    2010-06-01

    The global marine pharmaceutical pipeline consists of three Food and Drug Administration (FDA) approved drugs, one EU registered drug, 13 natural products (or derivatives thereof) in different phases of the clinical pipeline and a large number of marine chemicals in the preclinical pipeline. In the United States there are three FDA approved marine-derived drugs, namely cytarabine (Cytosar-U((R)), Depocyt((R))), vidarabine (Vira-A((R))) and ziconotide (Prialt((R))). The current clinical pipeline includes 13 marine-derived compounds that are either in Phase I, Phase II or Phase III clinical trials. Several key Phase III studies are ongoing and there are seven marine-derived compounds now in Phase II trials. The preclinical pipeline continues to supply several hundred novel marine compounds every year and those continue to feed the clinical pipeline with potentially valuable compounds. From a global perspective the marine pharmaceutical pipeline remains very active, and now has sufficient momentum to deliver several additional compounds to the marketplace in the near future; this review provides a current view of the pipeline.

  12. Current Pharmaceutical Treatments and Alternative Therapies of Parkinson's Disease.

    PubMed

    Dong, Jie; Cui, Yanhua; Li, Song; Le, Weidong

    2016-01-01

    Over the decades, pharmaceutical treatments, particularly dopaminergic (DAergic) drugs have been considered as the main therapy against motor symptoms of Parkinson's disease (PD). It is proposed that DAergic drugs in combination with other medications, such as monoamine oxidase type B inhibitors, catechol-O-methyl transferase inhibitors, anticholinergics and other newly developed non-DAergic drugs can make a better control of motor symptoms or alleviate levodopa-induced motor complications. Moreover, non-motor symptoms of PD, such as cognitive, neuropsychiatric, sleep, autonomic and sensory disturbances caused by intrinsic PD pathology or drug-induced side effects, are gaining increasing attention and urgently need to be taken care of due to their impact on quality of life. Currently, neuroprotective therapies have been investigated extensively in pre-clinical studies, and some of them have been subjected to clinical trials. Furthermore, non-pharmaceutical treatments, including deep brain stimulation (DBS), gene therapy, cell replacement therapy and some complementary managements, such as Tai chi, Yoga, traditional herbs and molecular targeted therapies have also been considered as effective alternative therapies to classical pharmaceutics. This review will provide us updated information regarding the current drugs and non-drugs therapies for PD. PMID:26585523

  13. Homochiral drugs: a demanding tendency of the pharmaceutical industry.

    PubMed

    Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

    2009-01-01

    The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.

  14. Hot-melt extrusion--basic principles and pharmaceutical applications.

    PubMed

    Lang, Bo; McGinity, James W; Williams, Robert O

    2014-09-01

    Originally adapted from the plastics industry, the use of hot-melt extrusion has gained favor in drug delivery applications both in academia and the pharmaceutical industry. Several commercial products made by hot-melt extrusion have been approved by the FDA, demonstrating its commercial feasibility for pharmaceutical processing. A significant number of research articles have reported on advances made regarding the pharmaceutical applications of the hot-melt extrusion processing; however, only limited articles have been focused on general principles regarding formulation and process development. This review provides an in-depth analysis and discussion of the formulation and processing aspects of hot-melt extrusion. The impact of physicochemical properties of drug substances and excipients on formulation development using a hot-melt extrusion process is discussed from a material science point of view. Hot-melt extrusion process development, scale-up, and the interplay of formulation and process attributes are also discussed. Finally, recent applications of hot-melt extrusion to a variety of dosage forms and drug substances have also been addressed.

  15. Drugs Approved for Thyroid Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) ...

  16. Drugs Approved for Prostate Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Prostate Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Prostate Cancer Abiraterone Acetate Bicalutamide Cabazitaxel Casodex (Bicalutamide) Degarelix Docetaxel ...

  17. Drugs Approved for Breast Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Keoxifene (Raloxifene Hydrochloride) Nolvadex (Tamoxifen ...

  18. Drugs Approved for Brain Tumors

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Brain Tumors This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Brain Tumors Afinitor (Everolimus) Afinitor Disperz (Everolimus) Avastin (Bevacizumab) ...

  19. Drugs Approved for Bone Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Bone Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Bone Cancer Abitrexate (Methotrexate) Cosmegen (Dactinomycin) Dactinomycin Denosumab Doxorubicin Hydrochloride ...

  20. Drugs Approved for Myeloproliferative Disorders

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Myeloproliferative Neoplasms This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Myeloproliferative Neoplasms Adriamycin PFS (Doxorubicin Hydrochloride) Adriamycin RDF (Doxorubicin Hydrochloride) ...

  1. Emergency medical kit for commercial airlines: an update.

    PubMed

    Thibeault, Claude

    2002-06-01

    As expected, the issue of medical kits for commercial airlines continues to attract attention, especially in light of the recent United States regulation on the subject. As promised in its first recommendation in 1998, the Air Transport Medicine (ATM) Committee has continued to monitor medical kit usage as well as pharmaceutical scientific developments and wishes to propose an update to its 1998 recommendation. Lists of contents are provided for emergency medical kits of two types: 1) those without defibrillator/monitor or monitor; and 2) those with defibrillator/monitor or monitor alone. Follow up and updates on this issue will be an ongoing task of the ATM Committee.

  2. Endocrine-Active Pharmaceuticals: An Environmental Concern?

    EPA Science Inventory

    Recently, there has been growing interest in pharmaceuticals that are specifically designed to have endocrine activity, such as the estrogens used in birth control pills, exerting unintended effects on fish and other aquatic organisms. These pharmaceuticals may not be persistent...

  3. Patrick Couvreur: inspiring pharmaceutical innovation.

    PubMed

    Stanwix, Hannah

    2014-05-01

    Patrick Couvreur speaks to Hannah Stanwix, Managing Comissioning Editor: Professor Patrick Couvreur received his pharmacy degree from the Université Catholique de Louvain (Louvain-la-Neuve, Belgium) in 1972. He holds a PhD in pharmaceutical technology from the same university and completed a postdoctoral fellowship at the Eidgenössische Technische Hochschule (Zürich, Switzerland). Since 1984, Professor Couvreur has been Full Professor of Pharmacy at the Paris-Sud University (Paris, France) and was holder of the Chair of Innovation Technologique at the prestigious Collège de France (Paris, France). He has published more than 450 peer-reviewed articles and has an H-index of 73, with over 19,000 citations. Professor Coureur has been recognized by numerous national and international awards, including the 2004 Pharmaceutical Sciences World Congress Award, the prestigious Host Madsen Medal, the Prix Galien, the European Pharmaceutical Scientist Award 2011 from the European Federation of Pharmaceutical Sciences, the Médaille de l'Innovation from the Centre National de la Recherche Scientifique, and recently the European Inventor Award 2013 from the European Patent Office.

  4. Pharmaceutical care in smoking cessation.

    PubMed

    Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

    2015-01-01

    As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. PMID:25678779

  5. Electron microscopy of pharmaceutical systems.

    PubMed

    Klang, Victoria; Valenta, Claudia; Matsko, Nadejda B

    2013-01-01

    During the last decades, the focus of research in pharmaceutical technology has steadily shifted towards the development and optimisation of nano-scale drug delivery systems. As a result, electron microscopic methods are increasingly employed for the characterisation of pharmaceutical systems such as nanoparticles and microparticles, nanoemulsions, microemulsions, solid lipid nanoparticles, different types of vesicles, nanofibres and many more. Knowledge of the basic properties of these systems is essential for an adequate microscopic analysis. Classical transmission and scanning electron microscopic techniques frequently have to be adapted for an accurate analysis of formulation morphology, especially in case of hydrated colloidal systems. Specific techniques such as environmental scanning microscopy or cryo preparation are required for their investigation. Analytical electron microscopic techniques such as electron energy-loss spectroscopy or energy-dispersive X-ray spectroscopy are additional assets to determine the elemental composition of the systems, but are not yet standard tools in pharmaceutical research. This review provides an overview of pharmaceutical systems of interest in current research and strategies for their successful electron microscopic analysis. Advantages and limitations of the different methodological approaches are discussed and recent findings of interest are presented. PMID:22921788

  6. Pharmaceutical care in smoking cessation

    PubMed Central

    Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

    2015-01-01

    As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. PMID:25678779

  7. Career pathways in research: pharmaceutical.

    PubMed

    Kenkre, J E; Foxcroft, D R

    The pharmaceutical pathway is the final article in this series on career pathways and highlights opportunities for nurses within associated industries. This pathway shows that nurses can use their nursing qualifications, combined with their knowledge, skills and expertise, to develop a career within another sphere of employment.

  8. Pharmaceutical crystallization with nanocellulose organogels.

    PubMed

    Ruiz-Palomero, Celia; Kennedy, Stuart R; Soriano, M Laura; Jones, Christopher D; Valcárcel, Miguel; Steed, Jonathan W

    2016-06-14

    Carboxylated nanocellulose forms organogels at 0.3 wt% in the presence of a cationic surfactant. The resulting gels can be used as novel crystallization media for pharmaceutical solid form control, resulting in isolation a new sulfapyridine solvate, morphology modification and crystallization of an octadecylammonium salt of sulfamethoxazole. PMID:27168091

  9. Position and enforcement practice of the People's Republic of China's pharmaceutical data exclusivity protection.

    PubMed

    Li, Na; Yu, Xiang; Pecht, Michael

    2016-01-01

    The concept of pharmaceutical data exclusivity protection comes from the West. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes the basic rules for pharmaceutical data exclusivity protection. People's Republic of China's domestic law is consistent with the TRIPS agreement. In the drug registration approval process of the People's Republic of China's Drug Supervision Department, pharmaceutical data exclusivity protection has encountered some problems, including data authentication, exclusive rights to data, number of drugs requiring data to be submitted, and drug costs. In view of the long-term interests of the People's Republic of China's pharmaceutical industry and intellectual property protection trends, there are a lot of difficulties in the enforcement of pharmaceutical data exclusivity protection law that need to be overcome. Some measures can be taken, such as establishing a shorter data exclusivity protection period, only protecting the data submitted and relied on in the People's Republic of China, only protecting the drugs that use new chemical components, allowing application and necessary research before the expiry of pharmaceutical data exclusivity protection period of generic drugs.

  10. Changing tides: Adaptive monitoring, assessment, and management of pharmaceutical hazards in the environment through time.

    PubMed

    Gaw, Sally; Brooks, Bryan W

    2016-04-01

    Pharmaceuticals are ubiquitous contaminants in aquatic ecosystems. Adaptive monitoring, assessment, and management programs will be required to reduce the environmental hazards of pharmaceuticals of concern. Potentially underappreciated factors that drive the environmental dose of pharmaceuticals include regulatory approvals, marketing campaigns, pharmaceutical subsidies and reimbursement schemes, and societal acceptance. Sales data for 5 common antidepressants (duloxetine [Cymbalta], escitalopram [Lexapro], venlafaxine [Effexor], bupropion [Wellbutrin], and sertraline [Zoloft]) in the United States from 2004 to 2008 were modeled to explore how environmental hazards in aquatic ecosystems changed after patents were obtained or expired. Therapeutic hazard ratios for Effexor and Lexapro did not exceed 1; however, the therapeutic hazard ratio for Zoloft declined whereas the therapeutic hazard ratio for Cymbalta increased as a function of patent protection and sale patterns. These changes in therapeutic hazard ratios highlight the importance of considering current and future drivers of pharmaceutical use when prioritizing pharmaceuticals for water quality monitoring programs. When urban systems receiving discharges of environmental contaminants are examined, water quality efforts should identify, prioritize, and select target analytes presently in commerce for effluent monitoring and surveillance.

  11. Changing tides: Adaptive monitoring, assessment, and management of pharmaceutical hazards in the environment through time.

    PubMed

    Gaw, Sally; Brooks, Bryan W

    2016-04-01

    Pharmaceuticals are ubiquitous contaminants in aquatic ecosystems. Adaptive monitoring, assessment, and management programs will be required to reduce the environmental hazards of pharmaceuticals of concern. Potentially underappreciated factors that drive the environmental dose of pharmaceuticals include regulatory approvals, marketing campaigns, pharmaceutical subsidies and reimbursement schemes, and societal acceptance. Sales data for 5 common antidepressants (duloxetine [Cymbalta], escitalopram [Lexapro], venlafaxine [Effexor], bupropion [Wellbutrin], and sertraline [Zoloft]) in the United States from 2004 to 2008 were modeled to explore how environmental hazards in aquatic ecosystems changed after patents were obtained or expired. Therapeutic hazard ratios for Effexor and Lexapro did not exceed 1; however, the therapeutic hazard ratio for Zoloft declined whereas the therapeutic hazard ratio for Cymbalta increased as a function of patent protection and sale patterns. These changes in therapeutic hazard ratios highlight the importance of considering current and future drivers of pharmaceutical use when prioritizing pharmaceuticals for water quality monitoring programs. When urban systems receiving discharges of environmental contaminants are examined, water quality efforts should identify, prioritize, and select target analytes presently in commerce for effluent monitoring and surveillance. PMID:26412644

  12. Position and enforcement practice of the People's Republic of China's pharmaceutical data exclusivity protection.

    PubMed

    Li, Na; Yu, Xiang; Pecht, Michael

    2016-01-01

    The concept of pharmaceutical data exclusivity protection comes from the West. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes the basic rules for pharmaceutical data exclusivity protection. People's Republic of China's domestic law is consistent with the TRIPS agreement. In the drug registration approval process of the People's Republic of China's Drug Supervision Department, pharmaceutical data exclusivity protection has encountered some problems, including data authentication, exclusive rights to data, number of drugs requiring data to be submitted, and drug costs. In view of the long-term interests of the People's Republic of China's pharmaceutical industry and intellectual property protection trends, there are a lot of difficulties in the enforcement of pharmaceutical data exclusivity protection law that need to be overcome. Some measures can be taken, such as establishing a shorter data exclusivity protection period, only protecting the data submitted and relied on in the People's Republic of China, only protecting the drugs that use new chemical components, allowing application and necessary research before the expiry of pharmaceutical data exclusivity protection period of generic drugs. PMID:27382254

  13. Pharmacodynamics of Memantine: An Update

    PubMed Central

    Rammes, G; Danysz, W; Parsons, C.G

    2008-01-01

    Memantine received marketing authorization from the European Agency for the Evaluation of Medicinal Products (EMEA) for the treatment of moderately severe to severe Alzheimer´s disease (AD) in Europe on 17th May 2002 and shortly thereafter was also approved by the FDA for use in the same indication in the USA. Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist with strong voltage-dependency and fast kinetics. Due to this mechanism of action (MOA), there is a wealth of other possible therapeutic indications for memantine and numerous preclinical data in animal models support this assumption. This review is intended to provide an update on preclinical studies on the pharmacodynamics of memantine, with an additional focus on animal models of diseases aside from the approved indication. For most studies prior to 1999, the reader is referred to a previous review [196]. In general, since 1999, considerable additional preclinical evidence has accumulated supporting the use of memantine in AD (both symptomatic and neuroprotective). In addition, there has been further confirmation of the MOA of memantine as an uncompetitive NMDA receptor antagonist and essentially no data contradicting our understanding of the benign side effect profile of memantine. PMID:19305788

  14. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval...

  15. Duchenne muscular dystrophy drugs face tough path to approval.

    PubMed

    Hodgkinson, L; Sorbera, L; Graul, A I

    2016-03-01

    Highly anticipated as new disease-modifying treatments for Duchenne muscular dystrophy (DMD), therapeutics by BioMarin Pharmaceutical (Kyndrisa™; drisapersen) and Sarepta Therapeutics (eteplirsen; AVI-4658) both recently received negative FDA reviews and are now facing battles for approval in the U.S. At present, BioMarin is committed to working with the FDA to forge a pathway to approval following the failure of its NDA, while Sarepta awaits the formal decision on its NDA, which is expected by late May 2016. Despite the critical nature of both reviews, analysts consider that there is still a narrow possibility of approval of both drugs. According to Consensus forecasts from Thomson Reuters Cortellis for Competitive Intelligence, Kyndrisa is forecast to achieve sales of USD 533.71 million in 2021. PMID:27186594

  16. Desperately seeking cancer drugs: explaining the emergence and outcomes of accelerated pharmaceutical regulation.

    PubMed

    Davis, Courtney; Abraham, John

    2011-07-01

    Government regulators have increasingly accelerated new cancer drugs on to the market by granting them approval based on less clinical data supporting drug efficacy than permitted under standard regulations. With more lenient regulatory standards, pharmaceutical companies have keenly sought to develop cancer drugs. Focusing on the US, this article examines how the emergence and implementation of such accelerated approvals should be understood, particularly in relation to corporate bias and disease-politics theories. Drawing on longitudinal and case study data analysis, it is argued that the emergence of accelerated approval regulations for cancer drugs should be regarded primarily as part of a deregulatory regime driven by the interests of the pharmaceutical industry in partnership with all major aspects of the state, rather than as a response to patient activism in the aftermath of AIDS. Furthermore, even in cases when some patients successfully demand accelerated marketing approval of cancer drugs, such approval by regulators, while in manufacturers' interests, may not be in the interests of patients' health because the political culture of the regulatory agency is reluctant to uphold its own techno-regulatory standards of public-health protection when that would challenge the agenda-setting influence of manufacturers, including industry collaborations with patients and the medical profession.

  17. Desperately seeking cancer drugs: explaining the emergence and outcomes of accelerated pharmaceutical regulation.

    PubMed

    Davis, Courtney; Abraham, John

    2011-07-01

    Government regulators have increasingly accelerated new cancer drugs on to the market by granting them approval based on less clinical data supporting drug efficacy than permitted under standard regulations. With more lenient regulatory standards, pharmaceutical companies have keenly sought to develop cancer drugs. Focusing on the US, this article examines how the emergence and implementation of such accelerated approvals should be understood, particularly in relation to corporate bias and disease-politics theories. Drawing on longitudinal and case study data analysis, it is argued that the emergence of accelerated approval regulations for cancer drugs should be regarded primarily as part of a deregulatory regime driven by the interests of the pharmaceutical industry in partnership with all major aspects of the state, rather than as a response to patient activism in the aftermath of AIDS. Furthermore, even in cases when some patients successfully demand accelerated marketing approval of cancer drugs, such approval by regulators, while in manufacturers' interests, may not be in the interests of patients' health because the political culture of the regulatory agency is reluctant to uphold its own techno-regulatory standards of public-health protection when that would challenge the agenda-setting influence of manufacturers, including industry collaborations with patients and the medical profession. PMID:21314687

  18. Pharmaceuticals: pharmaceutical cost controls--2005. End of Year Issue Brief.

    PubMed

    Seay, Melicia; Varma, Priya

    2005-12-31

    The enactment of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) gave states the option of offering pharmaceutical benefits within their Medicaid programs. But the law placed restrictions on states' flexibility to control what prescriptions they would cover and required the states to reimburse outpatient prescription drugs from manufacturers that signed rebate agreements with the U.S. Department of Health and Human Services. Forty-nine states--Arizona is excluded, based on its program structure--and the District of Columbia currently offer prescription drug coverage under the Medicaid Drug Rebate Program. During the past four years, states all over the country have been plagued with revenue shortfalls in their state Medicaid budgets. While the fiscal situation improved for most states in the 2004 legislative session, many states still face budget pressures in 2005. Compounding existing budget pressures are threats from the Bush Administration to shift increased costs of the Medicaid program on to the states. All things considered, the economic pressure of funding Medicaid is at the top of legislative agendas in 2005. As in previous years, states are attempting to reduce costs to their Medicaid programs by seeking savings in their pharmaceutical programs. Prescription drug costs are highly attributed as a contributing factor to the fiscal climate of state Medicaid programs. Currently, prescription drug spending outpaces that of every other category of health care and drug prices are rising faster than inflation. In response, states are instituting a variety of pharmaceutical cost control measures such as creating preferred drug lists (PDLs), negotiating supplemental rebates, forming bulk purchasing pools, promoting generic drug substitution and implementing price controls. As prescription drug cost containment tools have gained acceptance and momentum, they continue to be controversial. This issue brief explores the debate, history, methodology, utilization

  19. Drugs Approved for Neuroblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  20. Drugs Approved for Retinoblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  1. Drugs Approved for Leukemia

    Cancer.gov

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  2. 77 FR 6057 - Approval for Manufacturing Authority, Foreign-Trade Zone 22, Baxter Healthcare Corporation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ... Foreign-Trade Zones Board Approval for Manufacturing Authority, Foreign-Trade Zone 22, Baxter Healthcare Corporation, (Pharmaceutical and Biological Intravenous Product Manufacturing), Chicago, IL Pursuant to its... District, grantee of Foreign-Trade Zone 22, has requested manufacturing authority on behalf of...

  3. Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items.

    PubMed

    Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert A; Rosencrance, Susan M; Yu, Lawrence X

    2014-09-01

    Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS). During the first year of GDUFA implementation, from October 1, 2012 to September 30, 2013, approximately 1,500 Type II API DMFs received at least one cycle of CA review and more than 1,100 Type II DMFs were deemed complete and published on FDA's "Available for Reference List". The data from CA reviews were analyzed for factors that influenced the CA review process and metrics, as well as the areas of DMF submissions which most frequently led to an incomplete CA status. The metrics analysis revealed that electronic DMFs appear to improve the completeness of submission and shorten both the review and response times. Utilizing the CA checklist to compile and proactively update the DMFs improves the chance for the DMFs to pass the CA in the first cycle. However, given that the majority of DMFs require at least two cycles of CA before being deemed complete, it is recommended that DMF fees are paid 6 months in advance of the ANDA submissions in order to avoid negatively impacting the filling status of the ANDAs. PMID:25034968

  4. Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items.

    PubMed

    Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert A; Rosencrance, Susan M; Yu, Lawrence X

    2014-09-01

    Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS). During the first year of GDUFA implementation, from October 1, 2012 to September 30, 2013, approximately 1,500 Type II API DMFs received at least one cycle of CA review and more than 1,100 Type II DMFs were deemed complete and published on FDA's "Available for Reference List". The data from CA reviews were analyzed for factors that influenced the CA review process and metrics, as well as the areas of DMF submissions which most frequently led to an incomplete CA status. The metrics analysis revealed that electronic DMFs appear to improve the completeness of submission and shorten both the review and response times. Utilizing the CA checklist to compile and proactively update the DMFs improves the chance for the DMFs to pass the CA in the first cycle. However, given that the majority of DMFs require at least two cycles of CA before being deemed complete, it is recommended that DMF fees are paid 6 months in advance of the ANDA submissions in order to avoid negatively impacting the filling status of the ANDAs.

  5. Pharmaceutical development and regulatory considerations for nanoparticles and nanoparticulate drug delivery systems.

    PubMed

    Narang, Ajit S; Chang, Rong-Kun; Hussain, Munir A

    2013-11-01

    Pharmaceutical nanomaterials (NMs) encompass a wide variety of materials including drug nanoparticles (NPs), which can be amorphous or crystalline; or nanoparticulate drug delivery systems, such as micelles, microemulsions, liposomes, drug-polymer conjugates, and antibody-drug conjugates. These NMs are either transient or persistent-depending on whether the integrity of their structure and size is maintained until reaching the site of drug action. Examples of several approved drug products are included as pharmaceutical nanoparticulate systems along with a commentary on the current development issues and paradigms for various categories of NPs. This commentary discusses the preparation of nanoparticulate systems for commercial development, and the biopharmaceutical and pharmacokinetic advantages of these systems. A criterion of criticality is defined that incorporates the structure, in addition to size requirement of pharmaceutical NPs to identify systems that may require special development and regulatory considerations. PMID:24037829

  6. [Changes in the norms governing practices for the manufacture of pharmaceutical products: implications for the MERCOSUR].

    PubMed

    Temprano, G; Prats, S; Bregni, C

    1998-11-01

    It is done a comparative study between the "Recommended rules for drug products manufacturing and inspection", approved in 1975 by the World Health Organization (and still in force in the MERCOSUR); and the standards published in 1992 by the WHO Expert Committee on Specifications for Pharmaceutical Preparations 32nd Report, named "Good Manufacturing Practices for pharmaceutical products". The correspondence between the regulation in force in the MERCOSUR and the Good Manufacturing Practices Inspection Guide for pharmaceutical industry, used by Health Authorities in the Common Market Member States, is analysed. It is noticed a disagreement between the rule in force and the instrument for verifying its fulfillment. The proposal of this article is the adoption by the Common Market Group, of the rules published by the WHO in 1992, and the establishment of an inspection guide which absolute agrees with it.

  7. Volatile hydrocarbons in pharmaceutical solutions

    SciTech Connect

    Kroneld, R. )

    1991-07-01

    Volatile pollutants such as hydrocarbons have, during many years, been analysed in small concentrations in air, water, food, pharmaceutical solutions, and human blood and tissues. It has also been shown that such substances have unexpected consequences for cell cultures and scientific experiments. These substances also accumulate in patients receiving haemodialysis and these patients are exposed to quite high concentrations. The knowledge of the toxicity of such compounds has led to the development of maximum limit concentrations with the aim to decrease the exposure of humans. This paper discusses the problems of human exposure in general and especially through pharmaceutical solutions, and the possibilities of eliminating such compounds with the aim of decreasing the exposure as a hygienic challenge.

  8. Quality analytics of Internet pharmaceuticals.

    PubMed

    Baert, B; De Spiegeleer, B

    2010-09-01

    Trading pharmaceutical products through the Internet poses several challenges related to legal responsibilities, good distribution practices, information content and patient use, financial implications, but also regarding product quality. One of the major concerns is the well-known phenomenon of counterfeited and/or substandard drugs commercialized through rogue Internet sites. Therefore, controlling and assuring the quality of those products has become an important and challenging task for the authorities. This review gives an overview of the different quality attributes that can be evaluated to have a complete understanding of the quality of the finished pharmaceutical product traded through the Internet, as well as the current analytical techniques that serve this objective. Aspects considered are labelling and packaging, physicochemical quality attributes, identification and assay of active substances and/or excipients, impurity profiling, biopharmaceutical testing and data interpretation.

  9. Biosafe Nanoscale Pharmaceutical Adjuvant Materials

    PubMed Central

    Jin, Shubin; Li, Shengliang; Wang, Chongxi; Liu, Juan; Yang, Xiaolong; Wang, Paul C.; Zhang, Xin; Liang, Xing-Jie

    2014-01-01

    Thanks to developments in the field of nanotechnology over the past decades, more and more biosafe nanoscale materials have become available for use as pharmaceutical adjuvants in medical research. Nanomaterials possess unique properties which could be employed to develop drug carriers with longer circulation time, higher loading capacity, better stability in physiological conditions, controlled drug release, and targeted drug delivery. In this review article, we will review recent progress in the application of representative organic, inorganic and hybrid biosafe nanoscale materials in pharmaceutical research, especially focusing on nanomaterial-based novel drug delivery systems. In addition, we briefly discuss the advantages and notable functions that make these nanomaterials suitable for the design of new medicines; the biosafety of each material discussed in this article is also highlighted to provide a comprehensive understanding of their adjuvant attributes. PMID:25429253

  10. Economic analysis and pharmaceutical policy.

    PubMed

    Rovira, J

    1995-10-01

    Economic evaluation, a comparative analysis of alternative actions in terms of costs and consequences, allows rational decisions to be made concerning the deployment of resources (people, time, equipment, facilities and knowledge). Pharmaceutical policy reflects the various objectives of the many social groups, some of which are conflicting. While new methodologies for evaluation of health care programmes still need to gain wider acceptance, resource limitations for both care providers and decision makers make economic analysis an increasingly important tool.

  11. Pharmaceutical cocrystals: walking the talk.

    PubMed

    Bolla, Geetha; Nangia, Ashwini

    2016-06-28

    Pharmaceutical cocrystals belong to a sub-class of cocrystals wherein one of the components is a drug molecule (or an active pharmaceutical ingredient, API) and the second is a benign food or drug grade additive (generally regarded as safe, GRAS). The two components are hydrogen-bonded in a fixed stoichiometric ratio in the crystal lattice. In the past decade, pharmaceutical cocrystals have demonstrated significant promise in their ability to modify the physicochemical and pharmacokinetic properties of drug substances, such as the solubility and dissolution rate, bioavailability, particle morphology and size, tableting and compaction, melting point, physical form, biochemical and hydration stability, and permeability. In this feature review, we highlight some prominent examples of drug cocrystals which exhibit variable hardness/softness and elasticity/plasticity depending on coformer selection, improvement of solubility and permeability in the same cocrystal, increase of the melting point for solid formulation, enhanced color performance, photostability and hydration stability, and a longer half-life. Cocrystals of flavanoids and polyphenols can make improved pharmaceuticals and also extend to the larger class of nutraceuticals. The application of crystal engineering to assemble ternary cocrystals expands this field to drug-drug cocrystals which may be useful in multi-drug resistance, mitigating side effects of drugs, or attenuating/enhancing drug action synergistically by rational selection. The advent of new techniques for structural characterization beyond the standard X-ray diffraction will provide a better understanding of drug phases which are at the borderline of crystalline-amorphous nature and even newer opportunities in the future. PMID:27278109

  12. [E-commerce of pharmaceuticals].

    PubMed

    Shani, Segev

    2003-05-01

    The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications. PMID:12803063

  13. [E-commerce of pharmaceuticals].

    PubMed

    Shani, Segev

    2003-05-01

    The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

  14. Understanding pharmaceutical quality by design.

    PubMed

    Yu, Lawrence X; Amidon, Gregory; Khan, Mansoor A; Hoag, Stephen W; Polli, James; Raju, G K; Woodcock, Janet

    2014-07-01

    This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.

  15. Pharmaceutical study of Lauha Bhasma.

    PubMed

    Singh, Neetu; Reddy, K R C

    2010-07-01

    In the present research paper, the work done on pharmaceutical study of Lauha Bhasma conducted in the Department of Rasa Shastra under the postgraduate research programme is being presented. The pharmaceutical processing of Lauha Bhasma was performed by following samanya shodhana, vishesha shodhana and marana of Lauha. Under the process of marana, three specific pharmaceutical techniques were followed, viz. bhanupaka, sthalipaka and putapaka. During the putapaka process, an electric muffle furnace (EMF) was used. The temperature of puta was studied in two batches, viz. in Batch I, a temperature of 800°C was maintained whereas in Batch II, a temperature of 600°C was maintained. The purpose behind selecting two temperatures was to validate the process of marana of Lauha and to determine an ideal temperature for the preparation of Lauha Bhasma in EMF. It is found that after 20 puta at a temperature of 600°C, the Lauha Bhasma was prepared properly. The entire characteristic of Lauha Bhasma, like "pakwa jambu phala varna," varitar, etc. was attained at 600°. At a temperature of 800°C, the process could not be carried out smoothly. The pellets turned very hard and brassy yellow in color. The desired color was attained only after decreasing the temperature in further puta. PMID:22131745

  16. Examining pharmaceuticals using terahertz spectroscopy

    NASA Astrophysics Data System (ADS)

    Sulovská, Kateřina; Křesálek, Vojtěch

    2015-10-01

    Pharmaceutical trafficking is common issue in countries where they are under stricter dispensing regime with monitoring of users. Most commonly smuggled pharmaceuticals include trade names Paralen Plus, Modafen, Clarinase repetabs, Aspirin complex, etc. These are transported mainly from Eastern Europe (e.g. Poland, Ukraine, Russia) to countries like Czech Republic, which is said to have one of the highest number of methamphetamine producers in Europe. The aim of this paper is to describe the possibility of terahertz spectroscopy utilization as an examining tool to distinguish between pharmaceuticals containing pseudoephedrine compounds and those without it. Selected medicaments for experimental part contain as an active ingredient pseudoephedrine hydrochloride or pseudoephedrine sulphate. Results show a possibility to find a pseudoephedrine compound spectra in samples according to previously computed and experimentally found ones, and point out that spectra of same brand names pills may vary according to their expiration date, batch, and amount of absorbed water vapours from ambience. Mislead spectrum also occurs during experimental work in a sample without chosen active ingredient, which shows persistent minor inconveniences of terahertz spectroscopy. All measurement were done on the TPS Spectra 3000 instrument.

  17. Stability of Pharmaceuticals in Space

    NASA Technical Reports Server (NTRS)

    Nguyen, Y-Uyen

    2009-01-01

    Stability testing is a tool used to access shelf life and effects of storage conditions for pharmaceutical formulations. Early research from the International Space Station (ISS) revealed that some medications may have degraded while in space. This potential loss of medication efficacy would be very dangerous to Crew health. The aim of this research project, Stability of Pharmacotherapeutic Compounds, is to study how the stability of pharmaceutical compounds is affected by environmental conditions in space. Four identical pharmaceutical payload kits containing medications in different dosage forms (liquid for injection, tablet, capsule, ointment and suppository) were transported to the ISS aboard a Space Shuttle. One of the four kits was stored on that Shuttle and the other three were stored on the ISS for return to Earth at various time intervals aboard a pre-designated Shuttle flight. The Pharmacotherapeutics laboratory used stability test as defined by the United States Pharmacopeia (USP), to access the degree of degradation to the Payload kit medications that may have occurred during space flight. Once these medications returned, the results of stability test performed on them were compared to those from the matching ground controls stored on Earth. Analyses of the results obtained from physical and chemical stability assessments on these payload medications will provide researchers additional tools to promote safe and efficacious medications for space exploration.

  18. ISS Update: Suitport

    NASA Video Gallery

    ISS Update commentator Lynnette Madison interviews Mallory Jennings, Suitport Human Testing Lead, about making spacewalks easier and more efficient with the Suitport. Questions? Ask us on Twitter @...

  19. Issues in pharmaceutical development of thymosin alpha1 from preclinical studies through marketing.

    PubMed

    Tuthill, Cynthia

    2007-09-01

    SciClone Pharmaceuticals licensed the commercial and patent rights to thymosin alpha1, for geographical regions of the world excluding the United States and Europe, in the early 1990s. With this license, SciClone embarked on global drug development, and the issues encountered for thymosin alpha1 are reflective of the roller coaster of modern approval of pharmaceuticals. Most of the required toxicology studies had been completed prior to licensure, but some newer studies had to be conducted to obtain approvals in certain countries. The recent development of the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use" (ICH) guidelines allows for a clearer definition of the required battery of toxicology studies, although some countries still have not adopted these guidelines, and the local regulations have had to be understood and followed. Other hurdles include the complications that manufacturing requirements can differ between countries, and certain countries require local clinical experience trials in addition to SciClone's cumulative clinical data. A further obstacle was the pleiotropic nature of the mechanism of action of thymosin alpha1, with the resulting difficulty in the unraveling of its pharmacologic effects. With close attention to these regulatory details, SciClone has obtained approvals in more than 30 countries and has successfully begun commercial sales.

  20. Issues in pharmaceutical development of thymosin alpha1 from preclinical studies through marketing.

    PubMed

    Tuthill, Cynthia

    2007-09-01

    SciClone Pharmaceuticals licensed the commercial and patent rights to thymosin alpha1, for geographical regions of the world excluding the United States and Europe, in the early 1990s. With this license, SciClone embarked on global drug development, and the issues encountered for thymosin alpha1 are reflective of the roller coaster of modern approval of pharmaceuticals. Most of the required toxicology studies had been completed prior to licensure, but some newer studies had to be conducted to obtain approvals in certain countries. The recent development of the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use" (ICH) guidelines allows for a clearer definition of the required battery of toxicology studies, although some countries still have not adopted these guidelines, and the local regulations have had to be understood and followed. Other hurdles include the complications that manufacturing requirements can differ between countries, and certain countries require local clinical experience trials in addition to SciClone's cumulative clinical data. A further obstacle was the pleiotropic nature of the mechanism of action of thymosin alpha1, with the resulting difficulty in the unraveling of its pharmacologic effects. With close attention to these regulatory details, SciClone has obtained approvals in more than 30 countries and has successfully begun commercial sales. PMID:17947591

  1. Student Evaluation of Online Pharmaceutical Compounding Videos.

    PubMed

    Park, Hanna L; Shrewsbury, Robert P

    2016-03-25

    Objective. To describe pharmacy students' views on the effectiveness of an expansion of the compounding laboratory website at the UNC Eshelman School of Pharmacy. Methods. Originally, there were 39 videos and three animations available. In 2011, an additional 59 videos and two animations were added. Concurrently, all of the interactive questions were updated to fully integrate with the expanded video library. Students were surveyed about the expanded video library regarding accessibility, functionality, and usefulness, and how using the library impacted their learning of compounding. Surveys were analyzed with descriptive statistics. Means and SDs were calculated for the rating scale questions; independent t tests and Wilcoxon nonparametric tests were used to find differences between professional classes and campuses. Analytical results were evaluated with a one-way analysis of variance (ANOVA), z test, and a homogeneity of variance (Levene's) test. Results. The response rate to the survey was 85%. Compounding videos were used by 386/391 students. Thirty-four percent of students used the videos an average of 30 minutes or less per week; 56% used the videos 1-2 hours per week. Approximately 80% of students were satisfied with the functionality and accessibility of the videos. All students, regardless of professional year or campus affiliation, put their confidence/competence at about 70% of the rating scale. Conclusions. As no standardized compounding curriculum was found in US schools of pharmacy and students reported being satisfied with the website, it could be an accessible, functional, and useful resource for pharmaceutical compounding in schools of pharmacy.

  2. Student Evaluation of Online Pharmaceutical Compounding Videos.

    PubMed

    Park, Hanna L; Shrewsbury, Robert P

    2016-03-25

    Objective. To describe pharmacy students' views on the effectiveness of an expansion of the compounding laboratory website at the UNC Eshelman School of Pharmacy. Methods. Originally, there were 39 videos and three animations available. In 2011, an additional 59 videos and two animations were added. Concurrently, all of the interactive questions were updated to fully integrate with the expanded video library. Students were surveyed about the expanded video library regarding accessibility, functionality, and usefulness, and how using the library impacted their learning of compounding. Surveys were analyzed with descriptive statistics. Means and SDs were calculated for the rating scale questions; independent t tests and Wilcoxon nonparametric tests were used to find differences between professional classes and campuses. Analytical results were evaluated with a one-way analysis of variance (ANOVA), z test, and a homogeneity of variance (Levene's) test. Results. The response rate to the survey was 85%. Compounding videos were used by 386/391 students. Thirty-four percent of students used the videos an average of 30 minutes or less per week; 56% used the videos 1-2 hours per week. Approximately 80% of students were satisfied with the functionality and accessibility of the videos. All students, regardless of professional year or campus affiliation, put their confidence/competence at about 70% of the rating scale. Conclusions. As no standardized compounding curriculum was found in US schools of pharmacy and students reported being satisfied with the website, it could be an accessible, functional, and useful resource for pharmaceutical compounding in schools of pharmacy. PMID:27073283

  3. Student Evaluation of Online Pharmaceutical Compounding Videos

    PubMed Central

    Park, Hanna L.

    2016-01-01

    Objective. To describe pharmacy students’ views on the effectiveness of an expansion of the compounding laboratory website at the UNC Eshelman School of Pharmacy. Methods. Originally, there were 39 videos and three animations available. In 2011, an additional 59 videos and two animations were added. Concurrently, all of the interactive questions were updated to fully integrate with the expanded video library. Students were surveyed about the expanded video library regarding accessibility, functionality, and usefulness, and how using the library impacted their learning of compounding. Surveys were analyzed with descriptive statistics. Means and SDs were calculated for the rating scale questions; independent t tests and Wilcoxon nonparametric tests were used to find differences between professional classes and campuses. Analytical results were evaluated with a one-way analysis of variance (ANOVA), z test, and a homogeneity of variance (Levene’s) test. Results. The response rate to the survey was 85%. Compounding videos were used by 386/391 students. Thirty-four percent of students used the videos an average of 30 minutes or less per week; 56% used the videos 1–2 hours per week. Approximately 80% of students were satisfied with the functionality and accessibility of the videos. All students, regardless of professional year or campus affiliation, put their confidence/competence at about 70% of the rating scale. Conclusions. As no standardized compounding curriculum was found in US schools of pharmacy and students reported being satisfied with the website, it could be an accessible, functional, and useful resource for pharmaceutical compounding in schools of pharmacy. PMID:27073283

  4. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  5. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  6. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  7. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval...

  8. In Silico Models for Ecotoxicity of Pharmaceuticals.

    PubMed

    Roy, Kunal; Kar, Supratik

    2016-01-01

    Pharmaceuticals and their active metabolites are one of the significantly emerging environmental toxicants. The major routes of entry of pharmaceuticals into the environment are industries, hospitals, or direct disposal of unwanted or expired drugs made by the patient. The most important and distinct features of pharmaceuticals are that they are deliberately designed to have an explicit mode of action and designed to exert an effect on humans and other living systems. This distinctive feature makes pharmaceuticals and their metabolites different from other chemicals, and this necessitates the evaluation of the direct effects of pharmaceuticals in various environmental compartments as well as to living systems. In this background, the alarming situation of ecotoxicity of diverse pharmaceuticals have forced government and nongovernment regulatory authorities to recommend the application of in silico methods to provide quick information about the risk assessment and fate properties of pharmaceuticals as well as their ecological and indirect human health effects. This chapter aims to offer information regarding occurrence of pharmaceuticals in the environment, their persistence, environmental fate, and toxicity as well as application of in silico methods to provide information about the basic risk management and fate prediction of pharmaceuticals in the environment. Brief ideas about toxicity endpoints, available ecotoxicity databases, and expert systems employed for rapid toxicity predictions of ecotoxicity of pharmaceuticals are also discussed.

  9. Ibrutinib: first global approval.

    PubMed

    Cameron, Fiona; Sanford, Mark

    2014-02-01

    Ibrutinib (Imbruvica™) is a small molecule, first-in-class, once-daily, orally available, Bruton's tyrosine kinase inhibitor that is under development for the treatment of B cell malignancies, including chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL), as well as multiple myeloma (MM), follicular lymphoma (FL) and Waldenstrom's macroglobulinemia (WM). It has been developed by Pharmacyclics, Inc. and Janssen Biotech, Inc. Ibrutinib acts by blocking B-cell antigen receptor signalling, thereby reducing malignant proliferation of B cells and inducing cell death. Based chiefly on findings from a phase Ib/II study, ibrutinib has been approved in the USA for the treatment of MCL in previously treated patients and is one of the first approvals through the US FDA's Breakthrough Therapy Designation Pathway. An application has been filed in the EU seeking regulatory approval in this indication. In both the USA and EU, further applications have been filed with regulatory bodies seeking approval for the use of ibrutinib in patients with previously treated CLL/small lymphocytic lymphoma (SLL). Phase III trials are underway worldwide to evaluate ibrutinib in the treatment of patients with CLL/SLL, DLBCL and MCL, and the agent is in phase II development for use in WM, FL and MM. This article summarizes the milestones in the development of ibrutinib leading to its first approval in MCL.

  10. Afatinib: first global approval.

    PubMed

    Dungo, Rosselle T; Keating, Gillian M

    2013-09-01

    Afatinib, an irreversible inhibitor of the ErbB family of tyrosine kinases, is under development with Boehringer Ingelheim for the once-daily, oral treatment of cancer. Afatinib downregulates ErbB signalling by covalently binding to epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER) 2 and HER4, irreversibly inhibiting tyrosine kinase autophosphorylation. It also inhibits transphosphorylation of HER3. Oral afatinib (Gilotrif™) has been approved in the US for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC) who have tumours with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by a US FDA-approved test. Afatinib has also been approved in Taiwan for the first-line treatment of patients with EGFR mutation-positive NSCLC. In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of afatinib (Giotrif®) for the treatment of patients with locally advanced or metastatic NSCLC with activating EGFR mutations who are EGFR tyrosine kinase inhibitor naïve. Afatinib is also under regulatory review in Canada, Japan and other Asian countries. This article summarizes the milestones in the development of afatinib, leading to this first approval in patients with metastatic NSCLC.

  11. Medicines information provided by pharmaceutical representatives: a comparative study in Australia and Malaysia

    PubMed Central

    2010-01-01

    Background Pharmaceutical representatives provide medicines information on their promoted products to doctors. However, studies have shown that the quality of this information is often low. No study has assessed the medicines information provided by pharmaceutical representatives to doctors in Malaysia and no recent evidence in Australia is present. We aimed to compare the provision of medicines information by pharmaceutical representatives to doctors in Australia and Malaysia. Methods Following a pharmaceutical representative's visit, general practitioners in Australia and Malaysia who had agreed to participate, were asked to fill out a questionnaire on the main product and claims discussed during the encounter. The questionnaire focused on provision of product information including indications, adverse effects, precautions, contraindications and the provision of information on the Pharmaceutical Benefit Scheme (PBS) listings and restrictions (in Australia only). Descriptive statistics were produced. Chi-square analysis and clustered linear regression were used to assess differences in Australia and Malaysia. Results Significantly more approved product information sheets were provided in Malaysia (78%) than in Australia (53%) (P < 0.001). In both countries, general practitioners reported that indications (Australia, 90%, Malaysia, 93%) and dosages (Australia, 76%, Malaysia, 82%) were frequently provided by pharmaceutical representatives. Contraindications, precautions, drug interactions and adverse effects were often omitted in the presentations (range 25% - 41%). General practitioners in Australia and Malaysia indicated that in more than 90% of presentations, pharmaceutical representatives partly or fully answered their questions on contraindications, precautions, drug interactions and adverse effects. More general practitioners in Malaysia (85%) than in Australia (60%) reported that pharmaceutical representatives should have mentioned contraindications

  12. Pomalidomide: first global approval.

    PubMed

    Elkinson, Shelley; McCormack, Paul L

    2013-05-01

    Pomalidomide (Pomalyst(®)) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide has been approved in the USA and is awaiting approval in the EU for use with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma that has progressed following at least two prior therapies, including lenalidomide and bortezomib. The efficacy and safety of pomalidomide as monotherapy in patients with relapsed and refractory multiple myeloma has also been evaluated in a phase III trial. The agent is in phase III clinical development for the treatment of myelofibrosis and in phase II development for systemic sclerosis. Pomalidomide is also being investigated in patients with amyloidosis, prostate cancer, small cell lung cancer, pancreatic cancer, graft-versus-host disease, and Waldenstrom's macroglobulinaemia. This article summarizes the milestones in the development of pomalidomide leading to this first global approval for relapsed and refractory multiple myeloma.

  13. Olodaterol: first global approval.

    PubMed

    Gibb, Andrew; Yang, Lily P H

    2013-11-01

    Olodaterol (Striverdi(®) Respimat(®)) is a novel, long-acting, β2-adrenergic receptor agonist developed by Boehringer Ingelheim for the treatment of chronic obstructive pulmonary disease (COPD). The drug is delivered via the Respimat(®) Soft Mist™ inhaler. Olodaterol received its first global approval for the once-daily maintenance treatment of COPD in Canada and Russia, and submissions for regulatory approval have also been made in the USA, the EU and elsewhere. Phase II trials have been conducted in patients with asthma. The company is also developing a fixed-dose combination of olodaterol with tiotropium bromide, a long-acting anti-muscarinic agent, for the treatment of COPD. This article summarizes the milestones in the development of olodaterol leading to this first approval for COPD.

  14. Olodaterol: first global approval.

    PubMed

    Gibb, Andrew; Yang, Lily P H

    2013-11-01

    Olodaterol (Striverdi(®) Respimat(®)) is a novel, long-acting, β2-adrenergic receptor agonist developed by Boehringer Ingelheim for the treatment of chronic obstructive pulmonary disease (COPD). The drug is delivered via the Respimat(®) Soft Mist™ inhaler. Olodaterol received its first global approval for the once-daily maintenance treatment of COPD in Canada and Russia, and submissions for regulatory approval have also been made in the USA, the EU and elsewhere. Phase II trials have been conducted in patients with asthma. The company is also developing a fixed-dose combination of olodaterol with tiotropium bromide, a long-acting anti-muscarinic agent, for the treatment of COPD. This article summarizes the milestones in the development of olodaterol leading to this first approval for COPD. PMID:24158691

  15. Marketing approval of mogamulizumab

    PubMed Central

    Beck, Alain; Reichert, Janice M.

    2012-01-01

    Therapeutic properties of antibodies strongly depend on the composition of their glycans. Most of the currently approved antibodies are produced in mammalian cell lines, which yield mixtures of different glycoforms that are close to those of humans, but not fully identical. Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of mAbs. The recent approval in Japan of mogamulizumab (POTELIGEO®), the first glyco-engineered antibody to reach the market, is a landmark in the field of therapeutic antibodies. Mogamulizumab is a humanized mAb derived from Kyowa Hakko Kirin’s POTELLIGENT® technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. The approval was granted April 30, 2012 by the Japanese Ministry of Health, Labour and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma. PMID:22699226

  16. Ramucirumab: first global approval.

    PubMed

    Poole, Raewyn M; Vaidya, Asha

    2014-06-01

    Ramucirumab (Cyramza™ [US]), a fully human immunoglobulin G1 (IgG1) monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), has been developed by Eli Lilly (formerly ImClone Systems) for the treatment of cancer. Ramucirumab has received its first global approval in the US for use as monotherapy in the treatment of advanced or metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in patients who experience disease progression on or after fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is the first treatment to be approved by the US FDA for this setting. This article summarizes the milestones in the development of ramucirumab leading to this first approval for the treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma.

  17. Pembrolizumab: first global approval.

    PubMed

    Poole, Raewyn M

    2014-10-01

    Pembrolizumab [Keytruda(®) (US)], a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein, has been developed by Merck & Co for the treatment of cancer. Pembrolizumab has received its first global approval for the treatment of advanced, unresectable or metastatic malignant melanoma in the US, for use in patients with disease progression after prior treatment with ipilimumab and, for BRAF V600 mutation-positive patients, a BRAF inhibitor. It is the first anti-PD-1 therapy to receive regulatory approval in the US, and is currently under regulatory review in the EU. This article summarizes the milestones in the development of pembrolizumab leading to this first approval for the treatment of malignant melanoma.

  18. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

    PubMed

    2015-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities.

  19. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

    PubMed

    2015-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities. PMID:26118121

  20. Brivaracetam: First Global Approval.

    PubMed

    Markham, Anthony

    2016-03-01

    Brivaracetam (Briviact(®)), a 4-n-propyl analogue of levetiracetam developed by UCB Pharma, has been approved in the EU as an adjunctive therapy for the treatment of partial-onset seizures. Brivaracetam binds to synaptic vesicle glycoprotein 2a (SV2A) in the brain with greater selectivity and 15- to 30-fold higher affinity than levetiracetam, as demonstrated in preclinical models, and has demonstrated efficacy in reducing the frequency of partial onset seizures in clinical trials. This article summarizes the milestones in the development of brivaracetam leading to this first approval for use as adjunctive therapy for uncontrolled partial-onset seizures in adults with epilepsy. PMID:26899665

  1. Brodalumab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-09-01

    Brodalumab (Lumicef(®)) is a human monoclonal immunoglobulin G antibody that is being developed by Kyowa Hakko Kirin in Japan, where it has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. Brodalumab binds with high affinity to interleukin (IL)-17 receptor A, thereby inhibiting several pro-inflammatory cytokines from the IL-17 family. Regulatory applications for brodalumab in plaque psoriasis are also under review in the USA, EU and Canada. This article summarizes the milestones in the development of brodalumab leading to this first approval for the treatment of psoriasis. PMID:27577550

  2. Migalastat: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Migalastat (Galafold™)-a small molecule drug developed by Amicus Therapeutics that restores the activity of specific mutant forms of α-galactosidase-has been approved for the treatment of Fabry disease in the EU in patients with amenable mutations. Fabry disease is a rare disorder that results in a deficiency or absence of α-galactosidase, leading to accumulation of globotriaosylceramide in the lysosomes of various cells. This article summarizes the milestones in the development of migalastat leading to this first approval in the EU for the long-term treatment of adults and adolescents aged ≥16 years with a confirmed diagnosis of Fabry disease. PMID:27351440

  3. China: current trends in pharmaceutical drug discovery.

    PubMed

    Luo, Ying

    2008-04-01

    Pharmaceutical discovery and development is expensive and highly risky, even for multinational corporations. As a developing country with limited financial resources, China has been seeking the most cost-effective means to reach the same level of innovation and productivity as Western countries in the pharmaceutical industry sector. After more than 50 years of building up talent and experience, the time for China to become a powerhouse in pharmaceutical innovation is finally approaching. Returnee scientists to China are one of the reasons for the wave of new discovery and commercialization occurring within the country. The consolidation of local Chinese pharmaceutical companies and foreign investment is also providing an agreeable environment for the evolution of a new generation of biotechnology. The opportunity for pharmaceutical innovation is also being expedited by the entry of multinational companies into the Chinese pharmaceutical market, and by the outsourcing of research from these companies to China. PMID:18379963

  4. Introduction: Institutional corruption and the pharmaceutical policy.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations.

  5. Introduction: Institutional corruption and the pharmaceutical policy.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. PMID:24088143

  6. A qualitative glimpse at pharmaceutical care practice.

    PubMed

    Varela Dupotey, Niurka María; Ramalho de Oliveira, Djenane

    2009-12-01

    This manuscript presents an argument for a broader use of qualitative methodologies to investigate the practice and the surroundings of pharmaceutical care. Albeit the use of qualitative research methods is growing in the health care field, it is still insufficient in the area of pharmaceutical care. Pharmaceutical care, as a patient-centered practice, calls for a more comprehensive and humanistic approach to research. It is our contention that the attempt to understand pharmaceutical care practice from the perspective of patients, pharmacists and other health care professionals, by means of using qualitative methods, would notably contribute to a better assessment of the value of pharmaceutical care programs in the health care system. Moreover, because a deeper understanding of the nuances of this practice can be achieved with the use of qualitative methods, this approach might also assist us in making the necessary changes to create more effective pharmaceutical care practices.

  7. Approval tests and standards for closed-circuit escape respirators. Final rule.

    PubMed

    2012-03-01

    This final rule announces updated requirements that the National Institute for Occupational Safety and Health (NIOSH or Agency), located within the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS or Department), will employ to test and approve closed-circuit respirators used for escaping atmospheres considered to be immediately dangerous to life and health, including such respirators required by the Mine Safety and Health Administration (MSHA) for use in underground coal mines. NIOSH and MSHA jointly review and approve this type of respirator used for mine emergencies under regulations concerning approval of respiratory protective devices. NIOSH also approves these respirators for use in other work environments where escape equipment may be provided to workers, such as on vessels operated by U.S. Navy and Coast Guard personnel. The purpose of these updated requirements is to enable NIOSH and MSHA to more effectively ensure the performance, reliability, and safety of CCERs.

  8. Approval tests and standards for closed-circuit escape respirators. Final rule.

    PubMed

    2012-03-01

    This final rule announces updated requirements that the National Institute for Occupational Safety and Health (NIOSH or Agency), located within the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS or Department), will employ to test and approve closed-circuit respirators used for escaping atmospheres considered to be immediately dangerous to life and health, including such respirators required by the Mine Safety and Health Administration (MSHA) for use in underground coal mines. NIOSH and MSHA jointly review and approve this type of respirator used for mine emergencies under regulations concerning approval of respiratory protective devices. NIOSH also approves these respirators for use in other work environments where escape equipment may be provided to workers, such as on vessels operated by U.S. Navy and Coast Guard personnel. The purpose of these updated requirements is to enable NIOSH and MSHA to more effectively ensure the performance, reliability, and safety of CCERs. PMID:22420059

  9. Organic herbicide update

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Weed research is the top research priority among organic producers. Very few chemical weed control options are approved for organic use (corn gluten meal, vinegar, clove oil, and most recently ammonium pelargonate ), but additional compounds are under investigation and pursuing organic approval. C...

  10. New strategies for pharmaceutical design.

    PubMed

    Gillmor, S A; Cohen, F E

    1993-01-01

    Parallel synthesis and testing procedures are being investigated to shorten the drug design and discovery process. These procedures have focused on peptides and nucleotides, although these compounds are unlikely to be useful therapeutics because of their low bioavailability and sensitivity to enzymatic degradation. More recently, the use of other modular systems with distinct linking chemistries have been explored. Structural data combined with computational screens of compound databases provides an alternative method to identify novel nonpeptide pharmaceuticals. When structural information is not available, homology-based models have proved to be sufficient to identify nonpeptide inhibitors active at low micromolar concentrations against important enzymes in parasite life cycles. PMID:8167566

  11. Pharmaceutical Compounds Studied Using NEXAFS

    SciTech Connect

    Murray Booth, A.; Braun, Simon; Lonsbourough, Tom; Schroeder, Sven L. M.; Purton, John; Patel, Sunil

    2007-02-02

    Total Electron Yield (TEY) oxygen K-edge NEXAFS detects the presence of strongly adsorbed water molecules on poloxamer-coated pharmaceutical actives, which provides a useful spectroscopic indicator for bioavailability. The results are supported by complementary XPS measurements. Carbon K-edge spectra obtained in a high-pressure NEXAFS cell were used in situ to establish how a polymer coating spread on a drug surface by using humidity induced dispersion of the coating. Finally, we demonstrate how combined Carbon and Oxygen K-edge measurements can be used to characterize amorphous surface layers on micronised crystals of a drug compound.

  12. Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers

    EPA Science Inventory

    Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...

  13. Genomics and Health Impact Update

    MedlinePlus

    ... Genomics in Practice Newborn Screening Pharmacogenomics Reproductive Health Tools and Databases About the Genomics & Health Impact Update The Office of Public Health Genomics provides updated and credible ...

  14. Pharmaceutical Cocrystals and Their Physicochemical Properties

    PubMed Central

    2009-01-01

    Over the last 20 years, the number of publications outlining the advances in design strategies, growing techniques, and characterization of cocrystals has continued to increase significantly within the crystal engineering field. However, only within the last decade have cocrystals found their place in pharmaceuticals, primarily due to their ability to alter physicochemical properties without compromising the structural integrity of the active pharmaceutical ingredient (API) and thus, possibly, the bioactivity. This review article will highlight and discuss the advances made over the last 10 years pertaining to physical and chemical property improvements through pharmaceutical cocrystalline materials and, hopefully, draw closer the fields of crystal engineering and pharmaceutical sciences. PMID:19503732

  15. Toward a definition of pharmaceutical innovation.

    PubMed

    Morgan, Steven; Lopert, Ruth; Greyson, Devon

    2008-01-01

    ONGOING DEBATES IN THE PHARMACEUTICAL SECTOR ABOUT INTELLECTUAL PROPERTY, PRICING AND REIMBURSEMENT, AND PUBLIC RESEARCH INVESTMENTS HAVE A COMMON DENOMINATOR: the pursuit of innovation. However, there is little clarity about what constitutes a true pharmaceutical innovation, and as a result there is confusion about what kind of new products should be pursued, protected and encouraged through health policy and clinical practice. If the concept of pharmaceutical innovation can be clarified, then it may become easier for health policy-makers and practitioners to evaluate, adopt and procure products in ways that appropriately recognize, encourage and give priority to truly valuable pharmaceutical innovations.

  16. Specialty pharmaceuticals: developing a management plan.

    PubMed

    Willcutts, Dave

    2002-01-01

    This is the first in a series of articles that address the complex issues associated with specialty pharmaceuticals in the development of a successful specialty pharmaceutical program, a critical component of managing this high-cost and highly fragmented sector. This article focuses on how to define specialty pharmaceuticals. Other articles in this series will explore such topics as the mechanics of developing and managing a specialty pharmaceutical program, how and when to establish clinical protocols and authorizations, the importance of data management, and the benefits from automated processes.

  17. Entrepreneurial patent management in pharmaceutical startups.

    PubMed

    Holgersson, Marcus; Phan, Tai; Hedner, Thomas

    2016-07-01

    Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. PMID:26948802

  18. Simeprevir: first global approval.

    PubMed

    Vaidya, Asha; Perry, Caroline M

    2013-12-01

    Simeprevir (Sovriad(TM)) is a new direct-acting antiviral drug and a second-generation small-molecule NS3/4A serine protease inhibitor developed by Janssen and Medivir for the oral treatment of adults with genotype 1 and/or genotype 4 chronic hepatitis C virus (HCV) infection (chronic hepatitis C). Simeprevir antiviral activity is achieved by its non-covalent binding to HCV protease, with a fast association and slow dissociation rate. The capsule formulation is approved in Japan and Canada for use in combination with pegylated interferon (peginterferon) and ribavirin for genotype 1 chronic hepatitis C, and has been filed for approval in the US in this indication. In addition, the capsule formulation has been filed for approval in the EU for use in combination with peginterferon and ribavirin for genotype 1 and 4 chronic hepatitis C. Phase III trials of the capsule formulation of simeprevir are underway in several other regions, including China. In the pivotal phase III trials, simeprevir was administered once daily for 12 weeks in combination with peginterferon and ribavirin for 24 or 48 weeks. This article summarizes the milestones in the development of simeprevir leading to this first approval for chronic hepatitis C.

  19. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  20. GI Course Approvals.

    ERIC Educational Resources Information Center

    Orlans, Harold; And Others

    The process by which institutions and courses are approved for veterans educational benefits is examined in this study mandated by Public Law 95-202. The legislative background of the investigation is described as well as the history of the Servicemen's Readjustment Act of 1944, the Korean Bill of 1952, and P.L. 94-502 of 1976. A summary guide to…

  1. Gene-targeting pharmaceuticals for single-gene disorders.

    PubMed

    Beaudet, Arthur L; Meng, Linyan

    2016-04-15

    The concept of orphan drugs for treatment of orphan genetic diseases is perceived enthusiastically at present, and this is leading to research investment on the part of governments, disease-specific foundations and industry. This review attempts to survey the potential to use traditional pharmaceuticals as opposed to biopharmaceuticals to treat single-gene disorders. The available strategies include the use of antisense oligonucleotides (ASOs) to alter splicing or knock-down expression of a transcript, siRNAs to knock-down gene expression and drugs for nonsense mutation read-through. There is an approved drug for biallelic knock-down of the APOB gene as treatment for familial hypercholesterolemia. Both ASOs and siRNAs are being explored to knock-down the transthyretin gene to prevent the related form of amyloidosis. The use of ASOs to alter gene-splicing to treat spinal muscular atrophy is in phase 3 clinical trials. Work is progressing on the use of ASOs to activate the normally silent paternal copy of the imprinted UBE3A gene in neurons as a treatment for Angelman syndrome. A gene-activation or gene-specific ramp-up strategy would be generally helpful if such could be developed. There is exciting theoretical potential for converting biopharmaceutical strategies such gene correction and CRISPR-Cas9 editing to a synthetic pharmaceutical approach. PMID:26628634

  2. Drugs Approved for Lung Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Lung Cancer This page lists cancer ... in lung cancer that are not listed here. Drugs Approved for Non-Small Cell Lung Cancer Abitrexate ( ...

  3. Drugs Approved for Bladder Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Bladder Cancer This page lists cancer ... in bladder cancer that are not listed here. Drugs Approved for Bladder Cancer Atezolizumab Cisplatin Doxorubicin Hydrochloride ...

  4. Drugs Approved for Hodgkin Lymphoma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Hodgkin Lymphoma This page lists cancer ... in Hodgkin lymphoma that are not listed here. Drugs Approved for Hodgkin Lymphoma Adcetris (Brentuximab Vedotin) Ambochlorin ( ...

  5. Drugs Approved for Pancreatic Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Pancreatic Cancer This page lists cancer ... in pancreatic cancer that are not listed here. Drugs Approved for Pancreatic Cancer Abraxane (Paclitaxel Albumin-stabilized ...

  6. Drugs Approved for Testicular Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Testicular Cancer This page lists cancer ... in testicular cancer that are not listed here. Drugs Approved for Testicular Cancer Blenoxane (Bleomycin) Bleomycin Cisplatin ...

  7. Drugs Approved for Malignant Mesothelioma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Malignant Mesothelioma This page lists cancer ... in malignant mesothelioma that are not listed here. Drugs Approved for Malignant Mesothelioma Alimta (Pemetrexed Disodium) Pemetrexed ...

  8. Drugs Approved for Vulvar Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Vulvar Cancer This page lists cancer ... in vulvar cancer that are not listed here. Drugs Approved to Prevent Vulvar Cancer Gardasil (Recombinant HPV ...

  9. Drugs Approved for Cervical Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Cervical Cancer This page lists cancer ... in cervical cancer that are not listed here. Drugs Approved to Prevent Cervical Cancer Cervarix (Recombinant HPV ...

  10. Drugs Approved for Skin Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Skin Cancer This page lists cancer ... in skin cancer that are not listed here. Drugs Approved for Basal Cell Carcinoma Aldara (Imiquimod) Efudex ( ...

  11. Is It Really FDA Approved?

    MedlinePlus

    ... and implantable infusion pumps, require FDA approval before marketing. To receive FDA approval for these devices, the ... and many types of catheters) are cleared for marketing based on an FDA determination that they are ...

  12. Head Injury Screening Tests Approved

    MedlinePlus

    ... 160556.html Head Injury Screening Tests Approved Assess brain function after possible concussions To use the sharing features ... HealthDay News) -- New computer software to assess the brain's function after a traumatic head injury have been approved ...

  13. An analysis of FDA-approved drugs for oncology.

    PubMed

    Kinch, Michael S

    2014-12-01

    Cancer remains the second leading cause of death globally. The number of new medicines targeting cancer has grown impressively since the 1990s. On average, ten new drugs are introduced each year. Such growth has partly been achieved by emphasizing biologics and orphan indications, which account for one-quarter and one-half of new oncology drugs, respectively. The biotechnology industry likewise has become the primary driver of cancer drug development in terms of patents, preclinical and clinical research, although pharmaceutical companies are granted more FDA approvals. Many targeting strategies have been successful but recent trends suggest that kinase targets, although tractable, might be overemphasized.

  14. The Impact of Biotechnology on Pharmaceutics.

    ERIC Educational Resources Information Center

    Block, Lawrence H.

    1990-01-01

    The emergence of bioactive peptides and proteins as new drug species poses formidable problems for the pharmaceutical scientist. Implications for revision or change in undergraduate and graduate pharmaceutics curricula derive from the biopharmaceutical, pharmacokinetic, and physiochemical aspects of the new drug species, which differ from…

  15. Nanostructured materials in electroanalysis of pharmaceuticals.

    PubMed

    Rahi, A; Karimian, K; Heli, H

    2016-03-15

    Basic strategies and recent developments for the enhancement of the sensory performance of nanostructures in the electroanalysis of pharmaceuticals are reviewed. A discussion of the properties of nanostructures and their application as modified electrodes for drug assays is presented. The electrocatalytic effect of nanostructured materials and their application in determining low levels of drugs in pharmaceutical forms and biofluids are discussed.

  16. Biotech pharmaceuticals and biotherapy: an overview.

    PubMed

    Steinberg, F M; Raso, J

    1998-01-01

    Broadly, the history of pharmaceutical biotechnology includes Alexander Fleming"s discovery of penicillin in a common mold, in 1928, and the subsequent development-prompted by World War II injuries-of large-scale manufacturing methods to grow the organism in tanks of broth. Pharmaceutical biotechnology has since changed enormously. Two breakthroughs of the late 1970s became the basis of the modern biotech industry: the interspecies transplantation of genetic material, and the fusion of tumor cells and certain leukocytes. The cells resulting from such fusion-hybridomas-replicate endlessly and can be geared to produce specific antibodies in bulk. Modern pharmaceutical biotechnology encompasses gene cloning and recombinant DNA technology. Gene cloning comprises isolating a DNA-molecule segment that corresponds to a single gene and synthesizing ("copying") the segment. Recombinant DNA technology, or gene splicing, comprises altering genetic material outside an organism-for example, by inserting into a DNA molecule a segment from a very different DNA molecule-and making the altered material (recombinant DNA) function in living things. Recombinant DNA technology enables modifying microorganisms, animals, and plants so that they yield medically useful substances, particularly scarce human proteins (by giving animals human genes, for example). This review, however, focuses not on pharmaceutical biotechnology"s methods but on its products, notably recombinant pharmaceuticals. It describes various types of biotech pharmaceuticals, their safety and effectiveness relative to the safety and effectiveness of conventionally produced pharmaceuticals, and the regulation of biotech pharmaceuticals.

  17. Pharmaceutical experiment aboard STS-67 mission

    NASA Technical Reports Server (NTRS)

    1995-01-01

    Astronaut William G. Gregory, pilot, works with a pharmaceutical experiment on the middeck of the Earth-orbiting Space Shuttle Endeavour during the STS-67 mission. Commercial Materials Dispersion Apparatus Instruments Technology Associates Experiments (CMIX-03) includes not only pharmaceutical, but also biotechnology, cell biology, fluids, and crystal growth investigation

  18. Synthetic biology advances for pharmaceutical production

    PubMed Central

    Breitling, Rainer; Takano, Eriko

    2015-01-01

    Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872

  19. ISS Update: Suitport Testing

    NASA Video Gallery

    ISS Update commentator Lynnette Madison interviews Joel Maganza, Test Director, about thermal vacuum chambers and unmanned and human-testing with the Suitport. Questions? Ask us on Twitter @NASA_Jo...

  20. ISS Update: NEEMO 16

    NASA Video Gallery

    ISS Update commentator Josh Byerly interviews astronaut Stan Love about the NEEMO 16 mission from Aquarius Base. Questions? Ask us on Twitter @NASA_Johnson and include the hashtag #askStation. For ...

  1. ACS Updates Environmental Report.

    ERIC Educational Resources Information Center

    Chemical and Engineering News, 1978

    1978-01-01

    Describes a new publication of a report prepared by the American Chemical Society's Committee on Environmental Improvement. This is a new version that updates a 1969 report and contains additional material and expanded recommendations. (GA)

  2. Update on medicines for smoking cessation

    PubMed Central

    McDonough, Mike

    2015-01-01

    Summary Persistent cigarette smokers usually have a nicotine addiction. This addiction has a chronic relapsing and sometimes remitting course and may persist lifelong. Remission can be facilitated by the use of medication as part of a comprehensive management strategy tailored to the individual patient. Nicotine replacement therapy is a first-line drug treatment. It is available in many formulations. Varenicline is also a first-line drug treatment. It should be started before the patient stops smoking. Bupropion is a second-line therapy. It may be associated with an increased risk of seizures and drug interactions. While there is some evidence that electronic cigarettes might facilitate smoking cessation, quit rates are not yet comparable with those of the drugs approved on the Pharmaceutical Benefits Scheme. PMID:26648633

  3. Environmental regulatory update table

    SciTech Connect

    Brown, K.J.; Langston, M.E.; Tucker, C.S.; Reed, R.M.

    1987-06-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  4. Pharmaceutical counterfeiting and the RFID technology intervention.

    PubMed

    Coustasse, Alberto; Arvidson, Cody; Rutsohn, Phil

    2010-07-01

    Both nationally and internationally, pharmaceutical counterfeiting has become a problem that is threatening economic stability and public health. The purpose of the present research study review was to analyze the scope and severity of pharmaceutical counterfeiting and to establish if the implantation of the Radio Frequency Identification Device (RFID) model can more efficiently be used within the pharmaceutical supply chain to reduce the problem counterfeit drugs impose on public health and international economic stability. Results indicated that implementing the RFID model for tracking drugs at the item level in the pharmaceutical supply chain has potential to alleviate the scope of the counterfeit drug problem. Recommendations for how the pharmaceutical industry may sooner adopt the RFID model are made.

  5. Lixisenatide: first global approval.

    PubMed

    Elkinson, Shelley; Keating, Gillian M

    2013-03-01

    The selective once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Lyxumia(®)) is under development with Sanofi for the treatment of type 2 diabetes mellitus. Lixisenatide belongs to a class of GLP-1 compounds designed to mimic the endogenous hormone GLP-1. Native GLP-1 stimulates insulin secretion in a glucose-dependent manner, as well as suppressing glucagon production and slowing gastric emptying. A once-daily subcutaneous formulation of lixisenatide has been approved in the EU, Iceland, Liechtenstein, Norway and Mexico for the treatment of type 2 diabetes, and is under regulatory review in the USA, Switzerland, Brazil, Canada, Ukraine, South Africa, Japan and Australia. This article summarizes the milestones in the development of lixisenatide, leading to this first approval for use in adults with type 2 diabetes.

  6. Pitolisant: First Global Approval.

    PubMed

    Syed, Yahiya Y

    2016-09-01

    Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant has received a Temporary Authorization of Use in France for this indication in case of treatment failure, intolerance or contraindication to currently available treatment. Pitolisant has orphan drug designation in the EU and the USA. In the pivotal HARMONY I trial, pitolisant significantly decreased excessive daytime sleepiness versus placebo in adults with narcolepsy with or without cataplexy (primary endpoint). Pitolisant also significantly decreased cataplexy rate versus placebo in these patients. This article summarizes the milestones in the development of pitolisant leading to this first approval for narcolepsy. PMID:27438291

  7. Dabrafenib: first global approval.

    PubMed

    Ballantyne, Anita D; Garnock-Jones, Karly P

    2013-08-01

    Dabrafenib (Tafinlar®), a mutant-BRAF kinase inhibitor, emerged from GlaxoSmithKline's research programme for the discovery of selective inhibitors of mutant BRAF kinase activity, for the treatment of solid tumours; mutations in the BRAF gene are associated with increased growth and proliferation of cancer cells. GlaxoSmithKline has focused the development of dabrafenib on the treatment of malignant melanoma, as BRAF mutations are present in 50 % of these cancers. Dabrafenib is approved in the US as a single agent treatment for unresectable or metastatic melanoma in patients with the BRAF V600E mutation, and has received a positive opinion in the EU in this indication. Submissions have also been made in the US and the EU for the use of dabrafenib in combination with trametinib for the treatment of metastatic melanoma with a BRAF V600E/K mutation. Global phase III development of dabrafenib as a monotherapy and as a combination therapy is ongoing in the treatment of malignant melanoma. Phase II development is ongoing for the treatment of malignant melanoma that has metastasised to the brain, and for colorectal and non-small cell lung cancers. Dabrafenib is intended to treat the patient population with a BRAF V600E/K mutation. GlaxoSmithKline's dabrafenib application in the US included the treatment of this population as detected by a US FDA-approved test. GlaxoSmithKline, in collaboration with bioMérieux and Response Genetics, has developed a molecular theranostic test to identify BRAF V600E/K mutations. Pre-Market approval of the test has been granted by the FDA. This article summarises the milestones in the development of dabrafenib leading to this first approval as a single agent treatment for unresectable or metastatic melanoma in patients with the BRAF V600E mutation.

  8. Yucca Mountain repository approved

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    At a quiet White House ceremony on 23 July, U.S. President George W. Bush signed into law House Joint Resolution 87, which approves the site at Yucca Mountain, Nevada, for the development of a repository for disposing of high-level radioactive waste and spent nuclear fuel.White House spokesman Ari Fleischer called the signing “an important step forward on the way to a comprehensive policy for dealing with our nation's nuclear waste.”

  9. Mogamulizumab: first global approval.

    PubMed

    Subramaniam, Joshuan M; Whiteside, Glenn; McKeage, Kate; Croxtall, Jamie C

    2012-06-18

    Mogamulizumab (Poteligeo®) is a defucosylated, humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4). Development is being carried out by its owner Kyowa Hakko Kirin for various haematological malignancies, and by licensee Amgen for asthma. Mogamulizumab was conceived through Kyowa Hakko Kirin's Potelligent® technology, which produces antibodies with enhanced antibody-dependent cellular cytotoxicity. This is achieved largely by reducing fucose content in the oligosaccharide structure of the Fc region. Mogamulizumab has been approved in Japan for the treatment of relapsed or refractory adult T-cell leukaemia-lymphoma (ATL) and is the first Potelligent® antibody to receive marketing approval anywhere in the world. Phase II development is underway for adult T-cell leukaemia-lymphoma (ATL) and cutaneous T-cell lymphoma in the US, and for peripheral T-cell lymphoma in the US and Europe. Amgen is conducting a phase I US-based study in patients with asthma. This article summarizes the milestones in the development of intravenous mogamulizumab leading to this first approval. PMID:22686619

  10. Istradefylline: first global approval.

    PubMed

    Dungo, Rosselle; Deeks, Emma D

    2013-06-01

    Kyowa Hakko Kirin is developing istradefylline, a selective adenosine A2A receptor antagonist, for the once-daily oral treatment of Parkinson's disease (PD). Adenosine A2A receptors are considered to be present particularly in the basal ganglia of the brain; the degeneration or abnormality observed in PD is believed to occur in the basal ganglia, which is recognized to play a significant role in motor control. Commercially available dopamine replacement therapies effectively treat the early motor symptoms of PD; however, these agents are associated with development of motor complications, limiting usefulness in late stages of the disease. Istradefylline is proposed to possess a clearly distinct action site from existing agents which act on dopamine metabolism or dopamine receptors. Kyowa Hakko Kirin has received approval for istradefylline in the adjunctive treatment of PD in Japan. A New Drug Application was filed in the USA, but the FDA issued a non-approvable letter in February 2008. This article summarizes the milestones in the development of istradefylline leading to its first approval for the treatment of patients with PD.

  11. Vortioxetine: first global approval.

    PubMed

    Gibb, Andrew; Deeks, Emma D

    2014-01-01

    Vortioxetine is an orally administered small molecule developed by Lundbeck A/S for the once-daily treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). Vortioxetine received its first global approval for MDD in the USA in September 2013 and regulatory approval for its use in this indication in the EU (where it has received a positive opinion) and Canada is awaited. The drug is a bis-aryl-sulphanyl amine compound that combines serotonin (5-HT) reuptake inhibition with other characteristics, including receptor activity modulation. In vitro studies indicate that vortioxetine is an inhibitor of the 5-HT transporter and is a 5-HT(1D), 5-HT₃ and 5-HT₇ receptor antagonist, a 5-HT(1A) receptor agonist and a 5-HT(1B) receptor partial agonist. Animal and in vitro studies indicate that several neurotransmitter systems may be impacted by vortioxetine, with the drug enhancing levels of 5-HT, noradrenaline, dopamine, acetylcholine and histamine in certain areas of the brain, as well as modulating γ-aminobutyric acid and glutamate neurotransmission. Phase III trials of vortioxetine in both MDD and GAD have been conducted worldwide. This article summarizes the milestones in the development of vortioxetine leading to this first approval for MDD.

  12. Mogamulizumab: first global approval.

    PubMed

    Subramaniam, Joshuan M; Whiteside, Glenn; McKeage, Kate; Croxtall, Jamie C

    2012-06-18

    Mogamulizumab (Poteligeo®) is a defucosylated, humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4). Development is being carried out by its owner Kyowa Hakko Kirin for various haematological malignancies, and by licensee Amgen for asthma. Mogamulizumab was conceived through Kyowa Hakko Kirin's Potelligent® technology, which produces antibodies with enhanced antibody-dependent cellular cytotoxicity. This is achieved largely by reducing fucose content in the oligosaccharide structure of the Fc region. Mogamulizumab has been approved in Japan for the treatment of relapsed or refractory adult T-cell leukaemia-lymphoma (ATL) and is the first Potelligent® antibody to receive marketing approval anywhere in the world. Phase II development is underway for adult T-cell leukaemia-lymphoma (ATL) and cutaneous T-cell lymphoma in the US, and for peripheral T-cell lymphoma in the US and Europe. Amgen is conducting a phase I US-based study in patients with asthma. This article summarizes the milestones in the development of intravenous mogamulizumab leading to this first approval.

  13. Dolutegravir: first global approval.

    PubMed

    Ballantyne, Anita D; Perry, Caroline M

    2013-09-01

    Dolutegravir, an orally administered HIV-1 integrase strand transfer inhibitor (INSTI), is under development by ViiV Healthcare. Like other drugs belonging in the INSTI class of antiretroviral agents, dolutegravir binds to the integrase site of HIV-1 and blocks the strand transfer integration step, thereby preventing the replication of HIV-1. Dolutegravir is being developed as an unboosted once-daily therapy for use in combination with other antiretroviral agents for the treatment of both treatment-naïve and treatment-experienced patients with HIV-1 infection. Dolutegravir has been approved in the USA for the treatment of HIV-1 infection in combination with other antiretroviral agents and has been filed for approval in the EU and Canada. Phase III development is underway in North America, Europe, South Africa, South America, Australia and Taiwan. This article summarizes the milestones in the development of dolutegravir leading to this first approval for the treatment of HIV-1 infection in both therapy-naïve and -experienced patients.

  14. Evolocumab: First Global Approval.

    PubMed

    Markham, Anthony

    2015-09-01

    Evolocumab (Repatha™) is a fully human monoclonal antibody developed by Amgen that has been approved as a treatment for hypercholesterolaemia in the EU, and is awaiting approval in the USA and Japan. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a negative regulator of low-density lipoprotein (LDL)-receptors-thereby improving the ability of the liver to bind LDL-cholesterol (LDL-C), leading to reduced LDL-C blood levels. The drug reduces LDL-C levels in patients with hypercholesterolaemia when used as monotherapy or in conjunction with a statin. This article summarizes the milestones in the development of evolocumab leading to this approval for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet with or without a statin and/or other lipid lowering therapies, and in adults and adolescents aged ≥12 years with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

  15. Obiltoxaximab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-05-01

    Obiltoxaximab (Anthim(®), ETI-204) is a monoclonal antibody that is being developed by Elusys Therapeutics and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for the prevention and treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab has been designed to neutralize the free protective antigen of B. anthracis, thereby inhibiting the lethal effects of anthrax toxins. In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment (in combination with appropriate antibacterial drugs) and prophylaxis of inhalational anthrax. Obiltoxaximab is being developed under the US FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models and safety in phase I studies in healthy human volunteers. An intramuscular formulation of obiltoxaximab has also been evaluated in animal studies and a phase I study in healthy human volunteers. This article summarizes the milestones in the development of obiltoxaximab leading to this first approval for the treatment and prevention of inhalation anthrax. PMID:27085536

  16. A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.

    PubMed

    Hayes, Eileen P; Jolly, Robert A; Faria, Ellen C; Barle, Ester Lovsin; Bercu, Joel P; Molnar, Lance R; Naumann, Bruce D; Olson, Michael J; Pecquet, Alison M; Sandhu, Reena; Shipp, Bryan K; Sussman, Robert G; Weideman, Patricia A

    2016-08-01

    A European Union (EU) regulatory guideline came into effect for all new pharmaceutical products on June 1st, 2015, and for all existing pharmaceutical products on December 1st, 2015. This guideline centers around the use of the Acceptable Daily Exposure (ADE) [synonymous with the Permitted Daily Exposure (PDE)] and operational considerations associated with implementation are outlined here. The EU guidance states that all active pharmaceutical ingredients (API) require an ADE; however, other substances such as starting materials, process intermediates, and cleaning agents may benefit from an ADE. Problems in setting ADEs for these additional substances typically relate to toxicological data limitations precluding the ability to establish a formal ADE. Established methodologies such as occupational exposure limits or bands (OELs or OEBs) and the threshold of toxicological concern (TTC) can be used or adjusted for use as interim ADEs when only limited data are available and until a more formal ADE can be established. Once formal ADEs are derived, it is important that the documents are routinely updated and that these updates are communicated to appropriate stakeholders. Another key operational consideration related to data-poor substances includes the use of maximum daily dose (MDD) in setting cross-contamination limits. The MDD is an important part of the maximum allowable/safe concentration (MAC/MSC) calculation and there are important considerations for its use and definition. Finally, other considerations discussed include operational aspects of setting ADEs for pediatrics, considerations for large molecules, and risk management in shared facilities.

  17. Position and enforcement practice of the People’s Republic of China’s pharmaceutical data exclusivity protection

    PubMed Central

    Li, Na; Yu, Xiang; Pecht, Michael

    2016-01-01

    The concept of pharmaceutical data exclusivity protection comes from the West. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes the basic rules for pharmaceutical data exclusivity protection. People’s Republic of China’s domestic law is consistent with the TRIPS agreement. In the drug registration approval process of the People’s Republic of China’s Drug Supervision Department, pharmaceutical data exclusivity protection has encountered some problems, including data authentication, exclusive rights to data, number of drugs requiring data to be submitted, and drug costs. In view of the long-term interests of the People’s Republic of China’s pharmaceutical industry and intellectual property protection trends, there are a lot of difficulties in the enforcement of pharmaceutical data exclusivity protection law that need to be overcome. Some measures can be taken, such as establishing a shorter data exclusivity protection period, only protecting the data submitted and relied on in the People’s Republic of China, only protecting the drugs that use new chemical components, allowing application and necessary research before the expiry of pharmaceutical data exclusivity protection period of generic drugs. PMID:27382254

  18. 77 FR 14562 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... bleed horseshoe crabs at their facilities. Limulus Amoebocyte Lysate is derived from crab blood, which has no synthetic substitute, and is used by pharmaceutical companies to test sterility of products... published in the Federal Register (76 FR 59422) a notice of our intent to ask OMB to renew approval for...

  19. Pharmaceuticals: Medicare Modernization Act--2005. End of Year Issue Brief.

    PubMed

    Seay, Melicia

    2005-12-31

    The enactment of the landmark Medicare Modernization Act of 2003 (MMA) marked the first structural change to Medicare since its inception in 1965. The MMA established the Medicare prescription drug benefit with an intermediate Medicare-approved drug discount card program to be implemented six months after enactment and full implementation in January 2006. The MMA marks the first time the federal government would be providing access to prescription drugs for seniors. Though the merits and cost of the MMA continue to be debated, the impending change to how seniors and the low-income access prescription drugs is on the horizon. Historically, state lawmakers believed it was appropriate to provide assistance to the elderly and, in some states, the disabled and indigent, for the purchase of much needed prescription drugs. Since 1975, states have been creating, terminating and redesigning state pharmaceutical assistance programs (SPAPs) that either provides a prescription drug subsidy, discount card program or full benefit design. Currently, 33 states operate pharmaceutical assistance programs that provide coverage for seniors. Now, due to the MMA, the states' role as provider of prescription drug benefits to seniors is being re-evaluated. The MMA is intended to save costs for the states. Medicare beneficiaries, the bulk of enrollees in state pharmaceutical assistance programs, will now access prescription drugs through the new Medicare prescription drug benefit. The MMA mandates a state to federal government cost shift when the financial burden of those who are eligible for both Medicaid and Medicare (dual eligibles) switch to receiving prescription drug coverage through Medicare, with Medicaid only being an option for drugs not covered by Medicare. Employers, many of which have been cutting prescription drug benefits to retirees because of rising health care costs, will now receive subsidies from the federal government to continue providing prescription drug benefits to

  20. Vulnerabilities to misinformation in online pharmaceutical marketing.

    PubMed

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2013-05-01

    Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.

  1. 78 FR 59258 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Withdrawal of Direct...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-26

    ... Commonwealth of Pennsylvania's State Implementation Plan (SIP). The revisions consist of an update to the SIP-approved Motor Vehicle Emissions Budgets (MVEBs) for nitrogen oxides (NO X ) and volatile organic compounds... reference, Nitrogen dioxide, Ozone, Volatile organic compounds. Dated: August 29, 2013. W. C. Early,...

  2. 78 FR 59317 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Withdrawal of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-26

    ... Commonwealth of Pennsylvania's State Implementation Plan (SIP). The revisions consist of an update to the SIP-approved Motor Vehicle Emissions Budgets (MVEBs) for nitrogen oxides (NO X ) and volatile organic compounds... pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Volatile organic compounds....

  3. 77 FR 66945 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ...; Reasonably Available Control Technology Update To Address Control Techniques Guidelines Issued in 2006, 2007... revision establishes Reasonably Available Control Technology (RACT) for several categories of volatile organic compound (VOC) sources. The intended effect of this action is to approve these requirements...

  4. 76 FR 12405 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-07

    ... geographical information system/electronic airport layout plan. Design/construct west terminal parking... (radios). Airfield vault replacement. Flight information display system. Airport master plan update...-scheduled/ on-demand operators filing FAA Form 1800-31. Determination: Approved. Based on...

  5. 76 FR 43370 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... layout plan/geographic information system/Exhibit A update. Perimeter fence, phase 2. Perimeter fence... Description of Disapproved Project: Geographic information system--implementation. Determination: The FAA... Disapprovals. In June 2011, there were seven applications approved. This notice also includes information...

  6. 77 FR 3422 - Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-24

    ... Pollutants; State of West Virginia; Control of Emissions From Existing Hospital/Medical/Infectious Waste...: EPA proposes to approve a revision to the West Virginia hospital/medical/infectious waste incinerator... waste combustion that was updated as a result of the October 6, 2009 amendments to federal...

  7. 76 FR 17599 - Approval and Promulgation of Implementation Plans; State of Kansas

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... NAAQS. (62 FR 38894; 62 FR 38711). On January 8, 2008, EPA Region 7 received the state of Kansas' ozone... rulemaking (72 FR 10608).\\5\\ \\5\\ Subsequent to this approval, updated modeling in support of the proposed Transport Rule (75 FR 45210) has indicated that emissions from Kansas interfere with maintenance of the...

  8. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... distribution of the drug(s) made with the manufacturing change. (4) Changes and updated stability data to be... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Supplements and other changes to an approved application. 514.8 Section 514.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  9. 78 FR 57335 - Approval and Promulgation of Implementation Plans; State of Missouri; Conformity of General...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; State of Missouri; Conformity of... conformity rule in its entirety to bring it into compliance with the Federal general conformity rule which was updated in the Federal Register on April 5, 2010. General conformity regulations prohibit...

  10. 77 FR 18 - General Working Conditions in Shipyard Employment; Approval of Information Collection Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... final rule, published May 2, 2011 (76 FR 24576), became effective and enforceable on August 1, 2011... Employment on May 2, 2011 (76 FR 24576), updating existing requirements to reflect advances in industry... Federal Register announcing that OMB approved and assigned a control number to the requirements. See 76...

  11. 75 FR 13337 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-19

    ... Federal Aviation Administration Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals... boarding bridges (gates 1 and 4). Update airport layout plan and master plan. Prepare storm water pollution.... New field maintenance facility. Taxiway C and K rehabilitation. Aircraft rescue and...

  12. Another development in pharmaceuticals: an introduction.

    PubMed

    Streky, G

    1985-01-01

    The provision of appropriate medicines of the right kind, quality and quantity, and at reasonable prices is a central concern for any government. Simultaneously, there is increasing recognition of the serious problems inherent in the existing systems of pharmaceutical development, promotion, marketing, distribution and use in all countries and particularly in the 3rd World. The vast majority of people in most 3rd World countries have little or no access to effective and safe medicines. The Dag Hammarskjold Foundation organized a consultation on Another Development in Pharmaceuticals in June 1985. It was based on some papers commissioned for that occasion with a view to developing new approaches to fundamental problems in this field and involving both national and international actors and institutions. The basic concern of these papers was to place the debate on pharmaceuticals in its proper historical, contemporary and future context. The 5 major areas discussed were: 1) man and medicines: a historical perspective; 2) towards a healthy use of pharmaceuticals; 3) towards a healthy pharmaceutical industry by the year 2000; 4) 1st principles for the prescription, promotion and use of pharmaceuticals: towards a code of conduct; and 5) monitoring Another Development in Pharmaceuticals. 90% of the world's production of pharmaceuticals originates in the industrialized countries, which also accounts for 80% of the consumption. 3rd World countries have been supplied with a very inappropriate assortment of products by the pharmaceutical industry. There is a growing demand for improved practices that are conducive to health development. An international harmonization of regulatory standards is needed. PMID:12341048

  13. Proposing a redefinition of pharmaceutical care.

    PubMed

    Blackburn, David F; Yakiwchuk, Erin M; Jorgenson, Derek J; Mansell, Kerry D

    2012-03-01

    In many clinical practice settings, individual pharmaceutical care practitioners have thousands of patients who may receive their service. However, the pharmaceutical care approach provides virtually no guidance regarding how patients should be identified or prioritized by practicing pharmacists. We believe that pharmacists need to be "officially" accountable to specific patient groups at high risk for drug- or disease-induced morbidity within their practice. Consequently, the current definition of pharmaceutical care and its associated care processes need to be modified to ensure the activities of pharmacists are being focused on high-priority patients on a consistent basis. PMID:22395251

  14. Metrology in Pharmaceutical Industry - A Case Study

    NASA Astrophysics Data System (ADS)

    Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.

    2016-07-01

    Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area.

  15. Drug approval and surveillance.

    PubMed

    Potts, M

    1980-01-01

    This article argues that current regulations governing the licensing of drugs, particularly in the U.S., need to be changed and replaced by a system of provisional or conditional licensing and increased postmarketing surveillance of drug use. In terms of research and development of new forms of contraception, this proposal would have great impact. It is believed that the U.S./Food and Drug Administration (FDA) requirements--animal experiments and Phase 1 and 2 clinical trials--not only put an unacceptable financial burden on any institution attempting to develop new contraceptives, but do not demonstrably contribute to the reduction of risks. The author questions whether even if oral contraceptives introduced prior to new U.S./FDA regulations had been subject to these current regulations that convincing evidence would have been found to alert anyone to the now-known rare adverse effects, such as risk of thromboembolism. It is pointed out that these sorts of rare risks were uncovered by continuous screening processes which are not now a part of the FDA drug regulation requirements. The author also questions the politics of "conpulsory safety," such as might be legislated for regulated car safety belt use. Citing a partnership already established between government and private industry in high-risk/low cost ventures in the aerospace industry, the author sees no reason why such a relationship could not evolve in the pharmaceutical industry. In Britain, proposals have been made to establish a fund to compensate patients adversely affected by drugs which pharmaceutical companies would reimburse if proved negligent; such a fund may work in the U.S. under new regulations which stress postmarketing surveillance.

  16. Past, present and future of pharmaceutical patents under Korea-US Trade Agreement.

    PubMed

    Shin, Yoon Suk

    2016-07-01

    The introduction of substance patents in 1987 was viewed with apprehension as it was believed that the system would only reinforce the domination of the technology of advanced countries based on the trade agreement between Korea and the USA. However, substance patents provided the Korean pharmaceutical industry with the driving force required to develop new substances, and the Korean pharmaceutical industry has been constantly improving its research and development capability. The patent-approval linkage system was implemented according to the Korea-US Free Trade Agreement in 2015. The system comprises the following: registering the drugs in the Green List, notifying the listed patent and marketing approval holders about the application for generic marketing approval, patent holder's request for staying generic sales and first generic exclusivity. Korean generic companies are expected to have opportunities that enable them to challenge the global market by accumulating experience of designing of generic products, making patent challenges and strategically developing of new drugs or incrementally modified drugs through the linkage system. PMID:27338849

  17. Trametinib: first global approval.

    PubMed

    Wright, Cameron J M; McCormack, Paul L

    2013-07-01

    Trametinib is an orally bioavailable mitogen-activated protein kinase (MAPK) kinase (MEK) inhibitor with antineoplastic activity. The compound specifically binds to MEK1 and MEK2, resulting in inhibition of growth factor-mediated cell signalling and cellular proliferation in various cancers. Originally developed by Japan Tobacco, GlaxoSmithKline has licensed exclusive worldwide rights to the compound and conducted development in a number of different cancer types. Trametinib, as a monotherapy, has been approved in the US for the treatment of unresectable or metastatic malignant melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. The compound, as a monotherapy, has also been submitted for regulatory review in the EU for BRAF mutation-positive malignant melanoma, and is in phase III development in Europe, Argentina, Canada and Oceania. Phase II development is underway for pancreatic cancer, non-small cell lung cancer and relapsed or refractory leukaemias. GlaxoSmithKline is also developing trametinib for use in combination with dabrafenib in BRAF V600 mutation-positive metastatic cutaneous melanoma; the combination is at the preregistration stage in the EU and a phase III clinical programme is underway worldwide. Phase II development for this combination is also underway in colorectal cancer. Several phase I trials have also been initiated to evaluate trametinib in combination with other drugs for the treatment of various solid tumours and haematological malignancies. A paediatric oral solution formulation has been assessed against the oral tablet formulation in a phase I trial. This article summarizes the milestones in the development of trametinib leading to this first approval for unresectable or metastatic BRAF mutation-positive malignant melanoma.

  18. Update on tamper-resistant drug formulations.

    PubMed

    Romach, M K; Schoedel, K A; Sellers, E M

    2013-06-01

    An expert panel convened in 2005 by the College on Problems of Drug Dependence (CPDD) to consider strategies to reduce the risk of prescription medication abuse concluded that drug formulation plays a significant role in determining risk of abuse. Efforts on the part of the pharmaceutical industry to develop drugs that deter abuse have focused primarily on opioid formulations resistant to common forms of tampering, most notably crushing or dissolving the tablet to accelerate release. Several opioid formulations developed to be tamper resistant have been approved, but the US Food and Drug Administration has not approved explicit label claims of abuse deterrence and has stated that any such claim will require substantial postmarketing data. Drug development efforts in this area raise questions about the relative impact of abuse-deterrent formulations, not only on individuals who might abuse a medication, but also on patients who are compliant with therapy. This review discusses progress since the 2005 CPDD meeting with an emphasis on opioids. Articles cited in the review were identified via a PubMed search covering the period between January 1, 2000, and October 5, 2011. Scientific work presented by the authors and their colleagues at meetings held through May 2012 also was included. Published literature suggests that development of abuse-deterrent products will require broad public health support and continued encouragement from regulatory authorities so that such products will become the expected standard of care for certain drug classes.

  19. Data-mining for sulfur and fluorine: an evaluation of pharmaceuticals to reveal opportunities for drug design and discovery.

    PubMed

    Ilardi, Elizabeth A; Vitaku, Edon; Njardarson, Jon T

    2014-04-10

    Among carbon, hydrogen, oxygen, and nitrogen, sulfur and fluorine are both leading constituents of the pharmaceuticals that comprise our medicinal history. In efforts to stimulate the minds of both the general public and expert scientist, statistics were collected from the trends associated with therapeutics spanning 12 disease categories (a total of 1969 drugs) from our new graphical montage compilation: disease focused pharmaceuticals posters. Each poster is a vibrant display of a collection of pharmaceuticals (including structural image, Food and Drug Administration (FDA) approval date, international nonproprietary name (INN), initial market name, and a color-coded subclass of function) organized chronologically and classified according to an association with a particular clinical indication. Specifically, the evolution and structural diversity of sulfur and the popular integration of fluorine into drugs introduced over the past 50 years are evaluated. The presented qualitative conclusions in this article aim to promote innovative insights into drug development. PMID:24102067

  20. Indigenous and multinational pharmaceutical companies.

    PubMed

    Lilja, J

    1983-01-01

    There is a set of complex relationships between governments and the pharmaceutical companies. These relationships can be analysed in many different ways. In the following article the drug system of each country will be the unit of analysis. The drug system includes all the decision processes, formal as well as informal, from the production or importation of drugs to the intake of the drug by the patient. The aim of this paper is to discuss how environmental factors, the strategies of the drug companies and the national policies, will effect the drug system of a country. Satisfying solutions to the economical and health goals of the country will be searched for. If we want a more rational discussion in this area, professionally and politically, we need more empirical knowledge about the multinational drug companies and their effects on society. This does not mean that we shall sit waiting for this new knowledge. We have to make decisions using todays knowledge. However, in the long run rational decision strategy must include ways to collect important empirical data about the phenomenom under investigation. The aim of this survey is to indicate areas where we already have quite good knowledge and indicate other areas where this data is missing. PMID:6623122

  1. Japanese pill approval is bittersweet.

    PubMed

    Blankson-seck, N

    1999-01-01

    This article reports the controversy over the approval of a birth control pill in Japan. The birth control pill underwent a 9-year deliberation before it was approved in June as compared with the male impotence drug Viagra, which gained a quick approval from the government. Such quick approval made women's groups feel that this was characteristic of a societal bias. For years, the health ministers delayed the approval because supposedly more research was needed to determine the pill's safety and because of other reasons cited. What bothered these women's groups was the fact that the government kept citing the reason of safety as the cause of the delay, while, on the other hand, Viagra has claimed two lives since its approval. In this sense, many believe that culture still matters in Japan and such actions can be considered a gender issue.

  2. Utilization of pure nuclear quadrupole resonance spectroscopy for the study of pharmaceutical crystal forms.

    PubMed

    Pérez, S C; Cerioni, L; Wolfenson, A E; Faudone, S; Cuffini, S L

    2005-07-14

    Solid-state physical characterization of a pharmaceutical substance is necessary for successful development and approval of the final product. Different physical analytical techniques are available to do so: X-ray diffraction (XRD), IR, Raman, DSC, TG and NMR. Moreover, all of them detect the presence of excipients perturbing the analysis of the pure substance in low doses. In order to study polymorphism and pseudo polymorphism of drug, this paper introduces possible applications of pure nuclear quadrupole resonance, as a non-destructive technique in qualitative and quantitative approaches. Chlorpropamide and diclofenac sodium were used as examples. Unlike the mentioned techniques, the nuclear quadrupole resonance (NQR) signal of pharmaceutical compounds is not perturbed by the presence of solid excipient or other substances unless they possess resonance frequencies in the same frequency range of the compound studied.

  3. [Approval of a bone bank: an institution's experience].

    PubMed

    Jung, S; Wernerus, D; Reichel, H

    2012-03-01

    The new tissue laws of 2007 created a completely new situation for German musculoskeletal tissue banks. The objective of the new regulations in the recent German tissue act is to improve safety by reducing the risk of transmission of viral and nonviral diseases. Since 2007 tissue banks have to declare their intention to continue providing allografts to the local authorities until August 2011 based on the guidelines of the Federal Medical Association (Bundesärztekammer 2001) and according to § 144 of the Pharmaceutical Products Act (Arzneimittelgesetz). The Orthopedic University Clinic in Ulm applied for registration according to § 20 b and c of the Pharmaceutical Products Act in 2010. After submitting all the required documents, government officials controlled the equipment, distribution of responsible personnel, location of operating theatres and the laboratory and quality assurance documentation. After alluding to the lack of validation for the use of a hemoculture medium for testing ringer lactate solutions, permission according to § 20 b and c was granted with the obligation to transfer all serological and microbiological testing of tissue donors to another laboratory with its own approval under § 20 c of the Pharmaceutical Products Act.

  4. Information flow in the pharmaceutical supply chain.

    PubMed

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

    Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead.

  5. Pharmaceutical marketing research and the prescribing physician.

    PubMed

    Greene, Jeremy A

    2007-05-15

    Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.

  6. Information flow in the pharmaceutical supply chain.

    PubMed

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

    Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead. PMID:26664401

  7. Mergers and innovation in the pharmaceutical industry.

    PubMed

    Comanor, William S; Scherer, F M

    2013-01-01

    Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse?

  8. Pharmaceutical technology management--profitable business avenue.

    PubMed

    Puthli, Shivanand P

    2010-01-01

    Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business. PMID:20017657

  9. Paying for On-Patent Pharmaceuticals

    PubMed Central

    Goldfield, Norbert

    2016-01-01

    In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. We describe and define limit pricing as a method for drug companies to maximize revenue for their investment by offering budget-neutral pricing to encourage early adoption by payers. Under this approach, payers are incentivized to adopt innovative but expensive drugs more quickly if drug companies provide detailed analyses of the net impact of the new pharmaceutical upon total health budgets. For payers to adopt use of a new pharmaceutical, they would require objective third-party evaluation and pharmaceutical manufacturer accountability for projected outcomes efficacy of their treatments on population health. The pay for outcomes underpinning of this approach falls within the wider aspirations of health reform. PMID:26945298

  10. Active Pharmaceutical Ingredients and Aquatic Organisms

    EPA Science Inventory

    The presence of active pharmaceuticals ingredients (APIs) in aquatic systems in recent years has led to a burgeoning literature examining environmental occurrence, fate, effects, risk assessment, and treatability of these compounds. Although APIs have received much attention as ...

  11. Assessing the assessments: Pharmaceuticals in the environment

    SciTech Connect

    Enick, O.V. Moore, M.M.

    2007-11-15

    The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development.

  12. Information flow in the pharmaceutical supply chain

    PubMed Central

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

    Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead. PMID:26664401

  13. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS - THE GREEN PHARMACY

    EPA Science Inventory

    The occurrence of pharmaceuticals and personal care products (PPCPS) as environmental pollutants is a multifaceted issue whose scope continues to become better delineated since the escalation of conceited attention beginning in the 1980s. PPCPs typically occur as trace environme...

  14. MULTIFUNCTIONAL AND STIMULI-SENSITIVE PHARMACEUTICAL NANOCARRIERS

    PubMed Central

    Torchilin, Vladimir

    2011-01-01

    Currently used pharmaceutical nanocarriers, such as liposomes, micelles, and polymeric nanoparticles, demonstrate a broad variety of useful properties, such as longevity in the body; specific targeting to certain disease sites; enhanced intracellular penetration; contrast properties allowing for direct carrier visualization in vivo; stimili-sensitivity, and others. Some of those pharmaceutical carriers have already made their way into clinic, while others are still under preclinical development. In certain cases, the pharmaceutical nanocarriers combine several of the listed properties. Long-circulating immunoliposomes capable of prolonged residence in the blood and specific target recognition represent one of examples of this kind. The engineering of multifunctional pharmaceutical nanocarriers combining several useful properties in one particle can significantly enhance the efficacy of many therapeutic and diagnostic protocols. This paper considers the current status and possible future directions in the emerging area of multifunctional nanocarriers with primary attention on the combination of such properties as longevity, targetability, intracellular penetration, contrast loading, and stimuli sensitivity. PMID:18977297

  15. Ripasudil: first global approval.

    PubMed

    Garnock-Jones, Karly P

    2014-12-01

    Ripasudil hydrochloride hydrate (Glanatec® ophthalmic solution 0.4 %; hereafter referred to as ripasudil) is a small-molecule, Rho-associated kinase inhibitor developed by Kowa Company, Ltd. for the treatment of glaucoma and ocular hypertension. This compound, which was originally discovered by D. Western Therapeutics Institute, Inc., reduces intraocular pressure (IOP) by directly acting on the trabecular meshwork, thereby increasing conventional outflow through the Schlemm's canal. As a result of this mechanism of action, ripasudil may offer additive effects in the treatment of glaucoma and ocular hypertension when used in combination with agents such as prostaglandin analogues (which increase uveoscleral outflow) and β blockers (which reduce aqueous production). The eye drop product has been approved in Japan for the twice-daily treatment of glaucoma and ocular hypertension, when other therapeutic agents are not effective or cannot be administered. Phase II study is underway for the treatment of diabetic retinopathy. This article summarises the milestones in the development of ripasudil leading to the first approval for glaucoma and ocular hypertension. PMID:25414122

  16. Dinutuximab: first global approval.

    PubMed

    Dhillon, Sohita

    2015-05-01

    United Therapeutics Corporation and the National Cancer Institute are developing dinutuximab (Unituxin™; ch14.18), a monoclonal antibody targeting GD2, for the treatment of neuroblastoma. GD2 is a glycolipid found on the surface of tumour cells, which is overexpressed in neuroblastoma. Dinutuximab, an IgG1 human/mouse chimeric switch variant of murine monoclonal antibody 14G2a, binds to GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. The US FDA has recently approved the use of dinutuximab combination therapy for the treatment of high-risk neuroblastoma in paediatric patients. The marketing authorization application for dinutuximab is under regulatory review in the EU, and phase I-III development is underway in several other countries. This article summarizes the milestones in the development of dinutuximab leading to this first approval for use (in combination with granulocyte macrophage colony-stimulating factor, interleukin-2 and 13-cis retinoic acid) in the treatment of paediatric patients with high-risk neuroblastoma who achieve at least partial response to prior first-line multiagent, multimodality therapy. PMID:25940913

  17. The Chinese pharmaceutical market at the crossroads: pro-competition solutions to improve access, quality and affordability.

    PubMed

    Wang, Y Richard

    2005-01-01

    The Chinese pharmaceutical market is large in absolute size (the second largest in Asia), but it faces similar problems to those that plague other developing countries, such as a lack of adequate patent protection, low pharmaceutical spending per capita, but high pharmaceutical expenditure as a proportion of total medical spending, and a lack of health insurance coverage. In this article, the pros and cons of two pro-competition policy proposals for China are explored. The first proposal is to follow the E5 guideline of the International Conference on Harmonisation and waive unnecessary local clinical trials for global new drugs that have been approved by the US Food and Drug Administration or the European Medicines Agency (except for drugs for which there is a real possibility of there being ethnic differences in patient responses). The second proposal is to tighten the standards for generic drugs and approve only bioequivalent ones. While the first proposal encourages price competition between similar compounds in the same therapeutic class, the second proposal enhances generic competition for off-patent drugs. Working together, these two proposals would improve access to and the quality and affordability of pharmaceuticals in China.

  18. Pharmaceutical Formulation Facilities as Sources of Opioids and Other Pharmaceuticals to Wastewater Treatment Plant Effluents

    PubMed Central

    2010-01-01

    Facilities involved in the manufacture of pharmaceutical products are an under-investigated source of pharmaceuticals to the environment. Between 2004 and 2009, 35 to 38 effluent samples were collected from each of three wastewater treatment plants (WWTPs) in New York and analyzed for seven pharmaceuticals including opioids and muscle relaxants. Two WWTPs (NY2 and NY3) receive substantial flows (>20% of plant flow) from pharmaceutical formulation facilities (PFF) and one (NY1) receives no PFF flow. Samples of effluents from 23 WWTPs across the United States were analyzed once for these pharmaceuticals as part of a national survey. Maximum pharmaceutical effluent concentrations for the national survey and NY1 effluent samples were generally <1 μg/L. Four pharmaceuticals (methadone, oxycodone, butalbital, and metaxalone) in samples of NY3 effluent had median concentrations ranging from 3.4 to >400 μg/L. Maximum concentrations of oxycodone (1700 μg/L) and metaxalone (3800 μg/L) in samples from NY3 effluent exceeded 1000 μg/L. Three pharmaceuticals (butalbital, carisoprodol, and oxycodone) in samples of NY2 effluent had median concentrations ranging from 2 to 11 μg/L. These findings suggest that current manufacturing practices at these PFFs can result in pharmaceuticals concentrations from 10 to 1000 times higher than those typically found in WWTP effluents. PMID:20521847

  19. Pharmaceutical research: paradox, challenge or dilemma?

    PubMed

    Sheikh, Abdul Latif

    2006-01-01

    A great deal of pharmaceutical research is nowadays carried out in developing countries such as Pakistan. Is it, however, beneficial for the country and the participants, often the poorly educated and illiterate? Pharmaceutical research in Pakistan can bring benefits to both patients and country. Promotion of good clinical practice and the development of national guidelines are advocated. Government and industry both have a role to play to maintain the right balance.

  20. Bromination of selected pharmaceuticals in water matrices.

    PubMed

    Benitez, F Javier; Acero, Juan L; Real, Francisco J; Roldan, Gloria; Casas, Francisco

    2011-11-01

    The bromination of five selected pharmaceuticals (metoprolol, naproxen, amoxicillin, phenacetin, and hydrochlorothiazide) was studied with these compounds individually dissolved in ultra-pure water. The apparent rate constants for the bromination reaction were determined as a function of the pH, obtaining the sequence amoxicillin>naproxen>hydrochlorothiazide≈phenacetin≈metoprolol. A kinetic mechanism specifying the dissociation reactions and the species formed for each compound according to its pK(a) value and the pH allowed the intrinsic rate constants to be determined for each elementary reaction. There was fairly good agreement between the experimental and calculated values of the apparent rate constants, confirming the goodness of the proposed reaction mechanism. In a second stage, the bromination of the selected pharmaceuticals simultaneously dissolved in three water matrices (a groundwater, a surface water from a public reservoir, and a secondary effluent from a WWTP) was investigated. The pharmaceutical elimination trend agreed with the previously determined rate constants. The influence of the main operating conditions (pH, initial bromine dose, and characteristics of the water matrix) on the degradation of the pharmaceuticals was established. An elimination concentration profile for each pharmaceutical in the water matrices was proposed based on the use of the previously evaluated apparent rate constants, and the theoretical results agreed satisfactorily with experiment. Finally, chlorination experiments performed in the presence of bromide showed that low bromide concentrations slightly accelerate the oxidation of the selected pharmaceuticals during chlorine disinfection.

  1. Rejection of pharmaceuticals by forward osmosis membranes.

    PubMed

    Jin, Xue; Shan, Junhong; Wang, Can; Wei, Jing; Tang, Chuyang Y

    2012-08-15

    Rejection of four pharmaceutical compounds, carbamazepine, diclofenac, ibuprofen and naproxen, by forward osmosis (FO) membranes was investigated in this study. For the first time, the rejection efficiency of the pharmaceutical compounds was compared between commercial cellulose triacetate (CTA) based membranes and thin film composite (TFC) polyamide based membranes. The rejection behavior was related to membrane interfacial properties, physicochemical characteristics of the pharmaceutical molecules and feed solution pH. TFC polyamide membranes exhibited excellent overall performance, with high water flux, excellent pH stability and great rejection of all pharmaceuticals investigated (>94%). For commercial CTA based FO membranes, hydrophobic interaction between the compounds and membranes exhibited strong influence on their rejection under acidic conditions. The pharmaceuticals rejection was well correlated to their hydrophobicity (log D). Under alkaline conditions, both electrostatic repulsion and size exclusion contributed to the removal of deprotonated molecules. The pharmaceuticals rejection by CTA-HW membrane at pH 8 followed the order: diclofenac (99%)>carbamazepine (95%)>ibuprofen (93%) ≈ naproxen (93%). These results can be important for FO membrane synthesis, modification and their application in water purification. PMID:22640821

  2. The new pharmaceutical policy in Italy.

    PubMed

    Fattore, G; Jommi, C

    1998-10-01

    Pressed by an impressive series of corruption scandals and by a change of attitude towards cost-containment, the Italian pharmaceutical sector's regulatory environment was radically changed in 1994. Regulatory power was concentrated on a national technical body (CUF) and a new set of measures was taken, including a nationwide drug expenditure budget, a redefinition of both the positive list and the cost-sharing rules, and new price-setting models. As a result, in the period 1993-1996, nominal expenditures decreased by about L 1600 billion (ECU 83.6 billion at 1997 exchange rate), that is from 13.3% to 11.0% of current National Health Service (NHS) expenditure. While in the 1980s Italy was one of the most generous countries in funding pharmaceuticals, it is now one of the most parsimonious. Although the overall pharmaceutical market shrank in 1994 and 1995, a substantial part of NHS drug-bill savings resulted from cost-shifting from the public sector to patients, mainly because physicians have not aligned their prescribing behaviour to the new positive list. The new Italian approach to containing pharmaceutical costs has been certainly effective, at least in the short run. However, new relevant issues are emerging regarding the fall of NHS pharmaceutical coverage, the centralised nature of the Italian pharmaceutical policy and the gap between scientific based policies and actual prescribing behaviours.

  3. Viagra's rise above women's health issues: an analysis of the social and political influences on drug approvals in the United States and Japan.

    PubMed

    Hollander, Ilyssa

    2006-02-01

    In the United States, Viagra was approved in less than 6 months of its application to the Food and Drug Administration, while the medical abortion pill was approved 4 years after its application, and 17 years after research was first permitted. Congruently, the Ministry of Health in Japan legalized Viagra in 6 months, while oral contraceptives were approved 35 years after the ministry received initial applications. The pharmaceutical review agencies in each country are founded on safety and efficacy standards, in which objective decisions arise from science and clinical investigations. Analyses of these recent drug approvals demonstrate that conclusions may not have been based simply on science and health concerns. Instead, agency actions and application of pharmaceutical law appear to have been influenced by social and political pressures surrounding the products under scrutiny. Pharmaceutical regulations were effectively ignored or manipulated in the United States during the review process for medical abortion, and were applied inconsistently in Japan--ultimately yielding results that happened to conform to contemporary sociopolitical beliefs. Such disregard of legislation holds serious ramifications for public health, national consumer trust and the pharmaceutical industry. It is imperative that external pressures remain outside the scope of drug approval processes.

  4. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    PubMed

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

  5. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    PubMed

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media. PMID:27220801

  6. Updating: Learning versus Supposing

    ERIC Educational Resources Information Center

    Zhao, Jiaying; Crupi, Vincenzo; Tentori, Katya; Fitelson, Branden; Osherson, Daniel

    2012-01-01

    Bayesian orthodoxy posits a tight relationship between conditional probability and updating. Namely, the probability of an event "A" after learning "B" should equal the conditional probability of "A" given "B" prior to learning "B". We examine whether ordinary judgment conforms to the orthodox view. In three experiments we found substantial…

  7. ''Smart Gun'' Technology Update

    SciTech Connect

    WIRSBINSKI, JOHN W.

    2001-11-01

    This report is an update to previous ''smart gun'' work and the corresponding report that were completed in 1996. It incorporates some new terminology and expanded definitions. This effort is the product of an open source look at what has happened to the ''smart gun'' technology landscape since the 1996 report was published.

  8. Updated opal opacities

    SciTech Connect

    Iglesias, C.A.; Rogers, F.J.

    1996-06-01

    The reexamination of astrophysical opacities has eliminated gross discrepancies between a variety of observations and theoretical calculations; thus allowing for more detailed tests of stellar models. A number of such studies indicate that model results are sensitive to modest changes in the opacity. Consequently, it is desirable to update available opacity databases with recent improvements in physics, refinements of element abundance, and other such factors affecting the results. Updated OPAL Rosseland mean opacities are presented. The new results have incorporated improvements in the physics and numerical procedures as well as corrections. The main opacity changes are increases of as much as 20{percent} for Population I stars due to the explicit inclusion of 19 metals (compared to 12 metals in the earlier calculations) with the other modifications introducing opacity changes smaller than 10{percent}. In addition, the temperature and density range covered by the updated opacity tables has been extended. As before, the tables allow accurate interpolation in density and temperature as well as hydrogen, helium, carbon, oxygen, and metal mass fractions. Although a specific metal composition is emphasized, opacity tables for different metal distributions can be made readily available. The updated opacities are compared to other work. {copyright} {ital 1996 The American Astronomical Society.}

  9. SEI: An update

    NASA Technical Reports Server (NTRS)

    Peach, Lewis L., Jr.

    1991-01-01

    An update on the Space Exploration Initiative (SEI) is given in viewgraph form. Topics covered include the key prerequisites of human exploration, project planning, Mars and lunar explorations, supporting technologies, near-term strategies for SEI, human support elements, and Space Station Freedom SEI accommodations.

  10. Veterinary medicines update.

    PubMed

    2016-07-01

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:27365238

  11. Veterinary medicines update.

    PubMed

    2016-06-11

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:27288166

  12. Veterinary medicines update.

    PubMed

    2016-08-01

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:27493045

  13. Supreme Court Update

    ERIC Educational Resources Information Center

    Taylor, Kelley R.

    2009-01-01

    "Chief Justice Flubs Oath." "Justice Ginsburg Has Cancer Surgery." At the start of this year, those were the news headlines about the U.S. Supreme Court. But January 2009 also brought news about key education cases--one resolved and two others on the docket--of which school administrators should take particular note. The Supreme Court updates on…

  14. Community Update, 2001.

    ERIC Educational Resources Information Center

    Ashby, Nicole, Ed.

    2001-01-01

    This document consists of 10 issues (covering January through December 2000) of the newsletter, "Community Update," which features articles on community and family involvement in education. In addition to the articles, each issue (except the Special Issue) includes a preview of the month's Satellite Town Meeting; events and information discussed…

  15. Updating Older Fume Hoods.

    ERIC Educational Resources Information Center

    Saunders, G. Thomas

    1985-01-01

    Provides information on updating older fume hoods. Areas addressed include: (1) adjustment of the hood's back baffle; (2) hood air leakage; (3) light level; (4) hood location in relation to room traffic and room air; and (5) establishing and maintaining hood performance. (JN)

  16. Veterinary medicines update.

    PubMed

    2016-09-10

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:27609956

  17. Veterinary medicines update.

    PubMed

    2016-10-01

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:27687269

  18. Update: Biological Nitrogen Fixation.

    ERIC Educational Resources Information Center

    Wiseman, Alan; And Others

    1985-01-01

    Updates knowledge on nitrogen fixation, indicating that investigation of free-living nitrogen-fixing organisms is proving useful in understanding bacterial partners and is expected to lead to development of more effective symbioses. Specific areas considered include biochemistry/genetics, synthesis control, proteins and enzymes, symbiotic systems,…

  19. Technology Update-87

    SciTech Connect

    Not Available

    1987-12-01

    The five papers in this issue of Technology Update reflect improvements in equipment reliability, inspection techniques, data storage techniques, and production technology - all aimed at reducing process variations. Each paper represents an achievement by our technical staff that allows Mound to make more effective use of our resources. A separate abstract has been prepared for one of the papers.

  20. [The reference pricing of pharmaceuticals in European countries].

    PubMed

    Gildeyeva, G N; Starykh, D A

    2013-01-01

    The article presents the analysis of various approaches to estimation of pharmaceuticals prices in conditions of actual systems of pharmaceuticals support. The pricing is considered in pegging to actual systems of pharmaceuticals support based on the principles of insurance and co-financing. The detailed analysis is presented concerning the methodology of estimation of reference prices of pharmaceuticals in different countries of Europe. The experience of European countries in evaluation of interchangeability of pharmaceuticals is discussed.

  1. Stem cells in pharmaceutical biotechnology.

    PubMed

    Zuba-Surma, Ewa K; Józkowicz, Alicja; Dulak, Józef

    2011-11-01

    Multiple populations of stem cells have been indicated to potentially participate in regeneration of injured organs. Especially, embryonic stem cells (ESC) and recently inducible pluripotent stem cells (iPS) receive a marked attention from scientists and clinicians for regenerative medicine because of their high proliferative and differentiation capacities. Despite that ESC and iPS cells are expected to give rise into multiple regenerative applications when their side effects are overcame during appropriate preparation procedures, in fact their most recent application of human ESC may, however, reside in their use as a tool in drug development and disease modeling. This review focuses on the applications of stem cells in pharmaceutical biotechnology. We discuss possible relevance of pluripotent cell stem populations in developing physiological models for any human tissue cell type useful for pharmacological, metabolic and toxicity evaluation necessary in the earliest steps of drug development. The present models applied for preclinical drug testing consist of primary cells or immortalized cell lines that show limitations in terms of accessibility or relevance to their in vivo counterparts. The availability of renewable human cells with functional similarities to their in vivo counterparts is the first landmark for a new generation of cell-based assays. We discuss the approaches for using stem cells as valuable physiological targets of drug activity which may increase the strength of target validation and efficacy potentially resulting in introducing new safer remedies into clinical trials and the marketplace. Moreover, we discuss the possible applications of stem cells for elucidating mechanisms of disease pathogenesis. The knowledge about the mechanisms governing the development and progression of multitude disorders which would come from the cellular models established based on stem cells, may give rise to new therapeutical strategies for such diseases. All

  2. The shaping of pharmaceutical governance: the Israeli case

    PubMed Central

    2014-01-01

    This article focuses on governance of the pharmaceutical sector in Israel. It traces the relationships between the state, industry, and sick funds from before the establishment of National Health Insurance (NHI) in 1995 to the beginning of this decade, in particular as they have grappled with the challenge of making national formulary decisions in a rational manner. Subsequent to the introduction of NHI there have been shifts in the modes and mix of governance. This research shows empirically that a relatively complex mix of hierarchical and network modes of governance can be successfully established over an extended period of time when flexibility is maintained through the implementation process. The system for defining and updating a standard basket of health services has coped well with the challenge of managing a range of difficult and potentially volatile stakeholder relationships in the pharmaceutical sector and of distancing ministers from controversies of funding and listing decisions. Government has succeeded in containing drug costs whilst still maintaining a basket of reimbursable drugs that, from an international perspective, is comprehensive and technologically advanced. On the other hand, network arrangements appear to have delayed the introduction of suitable accountability relationships and hindered their development. The state has traditionally played an intermediary role between unavoidable corporate interests of industry and sick funds, with little transparency and to the detriment of more pluralistic access to decision making. Governance arrangements in Israel appear to limit the potential and incentive of the state and the sick funds to realize their potential countervailing powers in subsidy and pricing decisions. PMID:24914409

  3. The shaping of pharmaceutical governance: the Israeli case.

    PubMed

    Sax, Philip

    2014-01-01

    This article focuses on governance of the pharmaceutical sector in Israel. It traces the relationships between the state, industry, and sick funds from before the establishment of National Health Insurance (NHI) in 1995 to the beginning of this decade, in particular as they have grappled with the challenge of making national formulary decisions in a rational manner. Subsequent to the introduction of NHI there have been shifts in the modes and mix of governance. This research shows empirically that a relatively complex mix of hierarchical and network modes of governance can be successfully established over an extended period of time when flexibility is maintained through the implementation process. The system for defining and updating a standard basket of health services has coped well with the challenge of managing a range of difficult and potentially volatile stakeholder relationships in the pharmaceutical sector and of distancing ministers from controversies of funding and listing decisions. Government has succeeded in containing drug costs whilst still maintaining a basket of reimbursable drugs that, from an international perspective, is comprehensive and technologically advanced. On the other hand, network arrangements appear to have delayed the introduction of suitable accountability relationships and hindered their development. The state has traditionally played an intermediary role between unavoidable corporate interests of industry and sick funds, with little transparency and to the detriment of more pluralistic access to decision making. Governance arrangements in Israel appear to limit the potential and incentive of the state and the sick funds to realize their potential countervailing powers in subsidy and pricing decisions. PMID:24914409

  4. The shaping of pharmaceutical governance: the Israeli case.

    PubMed

    Sax, Philip

    2014-01-01

    This article focuses on governance of the pharmaceutical sector in Israel. It traces the relationships between the state, industry, and sick funds from before the establishment of National Health Insurance (NHI) in 1995 to the beginning of this decade, in particular as they have grappled with the challenge of making national formulary decisions in a rational manner. Subsequent to the introduction of NHI there have been shifts in the modes and mix of governance. This research shows empirically that a relatively complex mix of hierarchical and network modes of governance can be successfully established over an extended period of time when flexibility is maintained through the implementation process. The system for defining and updating a standard basket of health services has coped well with the challenge of managing a range of difficult and potentially volatile stakeholder relationships in the pharmaceutical sector and of distancing ministers from controversies of funding and listing decisions. Government has succeeded in containing drug costs whilst still maintaining a basket of reimbursable drugs that, from an international perspective, is comprehensive and technologically advanced. On the other hand, network arrangements appear to have delayed the introduction of suitable accountability relationships and hindered their development. The state has traditionally played an intermediary role between unavoidable corporate interests of industry and sick funds, with little transparency and to the detriment of more pluralistic access to decision making. Governance arrangements in Israel appear to limit the potential and incentive of the state and the sick funds to realize their potential countervailing powers in subsidy and pricing decisions.

  5. Strattera: An Important Update

    ERIC Educational Resources Information Center

    Coffey, Kenneth; Obringer, S. John

    2006-01-01

    An article published in the Fall 2004 issue of this journal discussed a recently approved drug, Strattera, which is used for children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The advantages and disadvantages of this medication were discussed in detail. However, there are new concerns about the use of Strattera after it has…

  6. Prostate cancer biomarkers: an update.

    PubMed

    Romero Otero, Javier; Garcia Gomez, Borja; Campos Juanatey, Felix; Touijer, Karim A

    2014-04-01

    Many aspects of prostate cancer diagnosis and treatment could be greatly advanced with new, effective biomarkers. Prostate-specific antigen (PSA) has multiple weaknesses as a biomarker, such as not distinguishing well between cancer and benign prostatic hyperplasia or between indolent and aggressive cancers, thus leading to overtreatment, especially unnecessary biopsies. PSA also often fails to indicate accurately which patients are responding to a given treatment. Yet PSA is the only prostate cancer biomarker routinely used by urologists. Here, we provide updated information on the most relevant of the other biomarkers currently in use or in development for prostate cancer. Recent research shows improvement over using PSA alone by comparing total PSA (tPSA) or free PSA (fPSA) with new, related markers, such as prostate cancer antigen (PCA) 3, the individual molecular forms of PSA (proPSA, benign PSA, and intact PSA), and kallikreins other than PSA. Promising results have also been seen with the use of the fusion gene TMPRSS2:ERG and with various forms of the urokinase plasminogen activation receptor. Initially, there were high hopes for early PCA, but those data were not reproducible and thus research on early PCA has been abandoned. Much work remains to be done before any of these biomarkers are fully validated and accepted. Currently, the only markers discussed in this paper with Food and Drug Administration-approved tests are PCA 3 and an isoform of proPSA, [-2]proPSA. Assays are in development for most of the other biomarkers described in this paper. While the biomarker validation process can be long and filled with obstacles, the rewards will be great-in terms of both patient care and costs to the health care system.

  7. 78 FR 76148 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... Performance Review Board as it was most recently published at 77 FR 64521 (October 22, 2012). Approved... From the Federal Register Online via the Government Publishing Office OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics...

  8. 77 FR 64521 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... it was most recently published at 76 FR 60840 (September 30, 2011). Approved: October 11, 2012. Don W... From the Federal Register Online via the Government Publishing Office OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics...

  9. 75 FR 62540 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ... published at 73 FR 53250-53251 (September 15, 2008). Approved: October 5, 2010. Robert I. Cusick, Director... From the Federal Register Online via the Government Publishing Office OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics...

  10. New Approaches in International Guidelines for Genetic Toxicology Assays: Latest Updates on OECD Guidelines

    EPA Science Inventory

    In March 2010, the 22nd meeting of the Working Group of National Coordinators of the OECD Test Guidelines Programme (WNT) approved a project for updating the Test Guidelines on genotoxicity, with Canada, the Netherlands, France and the USA identified as lead countries for this wo...

  11. A Dialogic about Using Facebook Status Updates for Education Research: A PhD Student's Journey

    ERIC Educational Resources Information Center

    Barnes, Naomi; Penn-Edwards, Sorrel; Sim, Cheryl

    2015-01-01

    Facebook status updates provided the data for a study about the transition learning experiences of 1st-year university students. Strict ethical guidelines were proposed by the PhD researcher from the outset of the study. Anonymity was considered important for the approved ethical clearance for both the university and the participants.…

  12. Determination of elemental impurities in pharmaceutical products and related matrices by ICP-based methods: a review.

    PubMed

    Barin, Juliano S; Mello, Paola A; Mesko, Marcia F; Duarte, Fabio A; Flores, Erico M M

    2016-07-01

    Interest in the determination of elemental impurities in pharmaceuticals has increased in recent years because of changes in regulatory requirements and the need for changing or updating the current limit tests recommended in pharmacopeias. Inductively coupled plasma (ICP) optical emission spectrometry and ICP mass spectrometry are suitable alternatives to perform multielemental analysis for this purpose. The main advantages and limitations of these techniques are described, covering the applications reported in the literature in the last 10 years mainly for active pharmaceutical ingredients, raw materials, and pharmaceutical dosage forms. Strategies used for sample preparation, including dissolution in aqueous or organic solvents, extraction, wet digestion and combustion methods are described, as well as direct solid analysis and ICP-based systems applied for speciation analysis. Interferences observed during the analysis of pharmaceutical products using ICP-based methods are discussed. Methods currently recommended by pharmacopeias for elemental impurities are also covered, showing that the use of ICP-based methods could be considered as a trend in the determination of these impurities in pharmaceuticals. However, the development of a general method that is accurate for all elemental impurities and the establishment of an official method are still challenges. In this regard, the main drawbacks and suitable alternatives are discussed.

  13. [Social change and Pharmaceutical Affairs Law (PAL)].

    PubMed

    Masuyama, Koichi; Isobe, Soichiro

    2010-01-01

    Former Japanese pharmaceutical laws, originally based on the Pharmaceutical Marketing and Handling Regulations enacted in 1874 were in operation for many years before World War II. However, in order to address several drug issues, such as poor drug quality and insufficiences regarding the role of pharmacists during the War, the laws needed to be unified and revised. In this paper, we analyzed the record of discussions held by the Imperial Diet on the bill for the Pharmaceutical Affairs Law (PAL) in 1943. This is also regarded as the origin of the current PAL (LawNo.145 in 1960). Through this analysis, we tried to clarify the relationship between the social change and the role of PAL in society. During the War, the bill was discussed, aiming at the improvement of both human resources who treated drugs, and the quality of drug materials. Diet members discussed three main points, namely, "the duty of pharmacists", "the mission of the Japan Pharmaceutical Association" and "the quality control of pharmaceutical products". Notably, the bill pharmacists are required not only to dispense drugs, a role they had previously, but also to manage drug and food hygiene through the quality control of pharmaceutical products and the inspection of food and drink, in order to improve the public health in Japan. Originally, the law was passed to deal with the extraordinary circumstances during the War, but through our analysis, we found that they proactively improved the role of the law to comply with various drug issues raised during the War, the rapid change of the pharmaceutical hygiene concept and the social transformation. PMID:21032892

  14. Water and stability of pharmaceutical solids

    NASA Astrophysics Data System (ADS)

    Shalaev, Evgenyi

    2007-03-01

    Solid pharmaceuticals are multi-component systems consisting of an active pharmaceutical ingredient (API) and inactive ingredients (excipients). Excipients may include inorganic salts (e.g., NaCl), carbohydrates (e.g., lactose), and polymers, to name a few, whereas APIs range from relatively simple molecules (e.g., aspirin) to proteins and olygonucleotides. Pharmaceutical solids could exist either as single-phase or heterophase systems. They also may have different extent of order, such as highly ordered crystalline phases, amorphous solids that are thermodynamically unstable but might be kinetically stable under the time frame of observation, and crystalline mesophases including liquid crystals. With all this diversity, there are common features for such systems, and two of them will be discussed in the presentation. (i) Requirements for chemical stability of pharmaceuticals are very strict. A very limited (e.g., less than 0.1%) extent of conversion is allowed in these materials over the shelf life, i.e., during several years of storage at ambient and (sometimes) not fully controlled (e.g., a medicine cabinet in one's bathroom) conditions. (ii) All pharmaceutical solids contain some water, although its amount and physical state are highly variable and may change during manufacturing and shelf life. There are many challenging questions and issues associated with the ``Water and stability of pharmaceutical solids'' subject; some of them will be considered in the presentation: (i) What are the features of chemical reactivity of crystalline vs disordered systems? (ii) What is the role of water in solid state chemical reactivity of amorphous solids, e.g., water as plasticizer vs reactant vs reaction media? (iii) How homogeneous are pharmaceutical amorphous solid solutions, e.g., carbohydrate-water systems? (iv) What is the optimal water content? With water being the most common destabilizing factor, is ``the drier - the better'' always the case?

  15. AN INFORMATIC APPROACH TO ESTIMATING ECOLOGICAL RISKS POSED BY PHARMACEUTICAL USE: HUMAN PRESCRIPTION PHARMACEUTICALS

    EPA Science Inventory

    Pharmaceuticals are often excreted from patients as the parent compound or as active metabolites. Some of these compounds have been found in the environment. However, the environmental concentrations of the majority of pharmaceuticals and their metabolites are not known. The re...

  16. Changing R&D models in research-based pharmaceutical companies.

    PubMed

    Schuhmacher, Alexander; Gassmann, Oliver; Hinder, Markus

    2016-01-01

    New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades. We aimed to identify, analyze and describe the factors that impact the R&D efficiency. Based on publicly available information, we reviewed the R&D models of major research-based pharmaceutical companies and analyzed the key challenges and success factors of a sustainable R&D output. We calculated that the R&D efficiencies of major research-based pharmaceutical companies were in the range of USD 3.2-32.3 billion (2006-2014). As these numbers challenge the model of an innovation-driven pharmaceutical industry, we analyzed the concepts that companies are following to increase their R&D efficiencies: (A) Activities to reduce portfolio and project risk, (B) activities to reduce R&D costs, and (C) activities to increase the innovation potential. While category A comprises measures such as portfolio management and licensing, measures grouped in category B are outsourcing and risk-sharing in late-stage development. Companies made diverse steps to increase their innovation potential and open innovation, exemplified by open source, innovation centers, or crowdsourcing, plays a key role in doing so. In conclusion, research-based pharmaceutical companies need to be aware of the key factors, which impact the rate of innovation, R&D cost and probability of success. Depending on their company strategy and their R&D set-up they can opt for one of the following open innovators: knowledge creator, knowledge integrator or knowledge leverager. PMID:27118048

  17. A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan.

    PubMed

    Tanimoto, Tetsuya

    2015-01-01

    The universal health care system in Japan is facing a historical turning point as a result of the increasing fiscal burden, rapidly aging society, and a decreasing population. To understand the challenges and opportunities in the Japanese pharmaceutical market, which occupies one tenth of the global share, this review highlights several issues related to the benefit-risk assessment that is unique to the modern Japanese society: 1) regulatory system for new drug development; 2) health hazards related to pharmaceuticals ("Yakugai" in Japanese); 3) drug lag; 4) problems and controversies in the vaccination policy; and 5) clinical study misconduct. The regulatory process places a significant importance on Japanese data collection regardless of data accumulation from other countries. Because Yakugai has repeatedly caused tragedies and social disputes historically, the regulatory judgments generally tend to be more prudential when safety concerns are raised for new and emerging pharmaceuticals. Such a regulatory system has caused more than several years of approval delays compared to delays in other countries. The problem of drug lag still lingers on despite several regulatory system revisions, while the solution is incompatible with the elimination of Yakugai because the lag potentially reduces the risk of unpredictable adverse events. The Japanese vaccination policy has also received a lot of criticism, and needs improvements so that the decision-making process can be more transparent and scientifically based. Additionally, repeated clinical study misconduct damaged the reputation of Japanese clinical studies with unnecessary defrayment in health insurance; therefore, the medical community must change its inappropriate relationship with the industry. The problems surrounding pharmaceuticals are related to centralized, strict drug pricing control under the universal health coverage. Although the current government attempts to facilitate innovative research and

  18. A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan.

    PubMed

    Tanimoto, Tetsuya

    2015-01-01

    The universal health care system in Japan is facing a historical turning point as a result of the increasing fiscal burden, rapidly aging society, and a decreasing population. To understand the challenges and opportunities in the Japanese pharmaceutical market, which occupies one tenth of the global share, this review highlights several issues related to the benefit-risk assessment that is unique to the modern Japanese society: 1) regulatory system for new drug development; 2) health hazards related to pharmaceuticals ("Yakugai" in Japanese); 3) drug lag; 4) problems and controversies in the vaccination policy; and 5) clinical study misconduct. The regulatory process places a significant importance on Japanese data collection regardless of data accumulation from other countries. Because Yakugai has repeatedly caused tragedies and social disputes historically, the regulatory judgments generally tend to be more prudential when safety concerns are raised for new and emerging pharmaceuticals. Such a regulatory system has caused more than several years of approval delays compared to delays in other countries. The problem of drug lag still lingers on despite several regulatory system revisions, while the solution is incompatible with the elimination of Yakugai because the lag potentially reduces the risk of unpredictable adverse events. The Japanese vaccination policy has also received a lot of criticism, and needs improvements so that the decision-making process can be more transparent and scientifically based. Additionally, repeated clinical study misconduct damaged the reputation of Japanese clinical studies with unnecessary defrayment in health insurance; therefore, the medical community must change its inappropriate relationship with the industry. The problems surrounding pharmaceuticals are related to centralized, strict drug pricing control under the universal health coverage. Although the current government attempts to facilitate innovative research and

  19. Changing R&D models in research-based pharmaceutical companies.

    PubMed

    Schuhmacher, Alexander; Gassmann, Oliver; Hinder, Markus

    2016-04-27

    New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades. We aimed to identify, analyze and describe the factors that impact the R&D efficiency. Based on publicly available information, we reviewed the R&D models of major research-based pharmaceutical companies and analyzed the key challenges and success factors of a sustainable R&D output. We calculated that the R&D efficiencies of major research-based pharmaceutical companies were in the range of USD 3.2-32.3 billion (2006-2014). As these numbers challenge the model of an innovation-driven pharmaceutical industry, we analyzed the concepts that companies are following to increase their R&D efficiencies: (A) Activities to reduce portfolio and project risk, (B) activities to reduce R&D costs, and (C) activities to increase the innovation potential. While category A comprises measures such as portfolio management and licensing, measures grouped in category B are outsourcing and risk-sharing in late-stage development. Companies made diverse steps to increase their innovation potential and open innovation, exemplified by open source, innovation centers, or crowdsourcing, plays a key role in doing so. In conclusion, research-based pharmaceutical companies need to be aware of the key factors, which impact the rate of innovation, R&D cost and probability of success. Depending on their company strategy and their R&D set-up they can opt for one of the following open innovators: knowledge creator, knowledge integrator or knowledge leverager.

  20. A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan

    PubMed Central

    Tanimoto, Tetsuya

    2015-01-01

    The universal health care system in Japan is facing a historical turning point as a result of the increasing fiscal burden, rapidly aging society, and a decreasing population. To understand the challenges and opportunities in the Japanese pharmaceutical market, which occupies one tenth of the global share, this review highlights several issues related to the benefit-risk assessment that is unique to the modern Japanese society: 1) regulatory system for new drug development; 2) health hazards related to pharmaceuticals (“Yakugai” in Japanese); 3) drug lag; 4) problems and controversies in the vaccination policy; and 5) clinical study misconduct. The regulatory process places a significant importance on Japanese data collection regardless of data accumulation from other countries. Because Yakugai has repeatedly caused tragedies and social disputes historically, the regulatory judgments generally tend to be more prudential when safety concerns are raised for new and emerging pharmaceuticals. Such a regulatory system has caused more than several years of approval delays compared to delays in other countries. The problem of drug lag still lingers on despite several regulatory system revisions, while the solution is incompatible with the elimination of Yakugai because the lag potentially reduces the risk of unpredictable adverse events. The Japanese vaccination policy has also received a lot of criticism, and needs improvements so that the decision-making process can be more transparent and scientifically based. Additionally, repeated clinical study misconduct damaged the reputation of Japanese clinical studies with unnecessary defrayment in health insurance; therefore, the medical community must change its inappropriate relationship with the industry. The problems surrounding pharmaceuticals are related to centralized, strict drug pricing control under the universal health coverage. Although the current government attempts to facilitate innovative research and

  1. Microbial growth in small-volume pharmaceuticals.

    PubMed

    Whyte, W; Niven, L; Bell, N D

    1989-01-01

    The ability of aseptically filled pharmaceuticals to support microbial growth was tested on 43 small-volume products (mainly parenterals). These were inoculated with a variety of microorganisms which were known to be associated with contamination of pharmaceutical products. In general, Gram-negative bacteria were found to be much more likely to grow than Gram-positive. It was possible for an inoculum of a few cells to multiply to levels up to 10(7)/mL. The presence of preservatives also influenced the likelihood of growth, 12 out of 19 (63%) of the pharmaceuticals without preservatives supporting growth of one or more microorganisms; only 3 out of 24 (12%) of those with preservatives supported growth. The importance of these observations is discussed with reference to formulation of aseptically filled products, environmental sampling and the quality of cleanroom conditions necessary for production. It is suggested that those pharmaceuticals which are designed to be sterile but not to be terminally sterilized, should be tested before production begins, for their ability to support microbial growth. In this way, the risks involved in aseptically filling can be ascertained. A test is proposed in which "indicator" microorganisms would predict the likelihood of pharmaceutical formulations supporting growth.

  2. Pharmaceutical supply chain risks: a systematic review

    PubMed Central

    2013-01-01

    Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Methods Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Results Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. Conclusion It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies. PMID:24355166

  3. Case histories in pharmaceutical risk management.

    PubMed

    McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E

    2009-12-01

    The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS). PMID:19767156

  4. Pharmaceutical identifier confirmation via DART-TOF.

    PubMed

    Easter, Jacob L; Steiner, Robert R

    2014-07-01

    Pharmaceutical analysis comprises a large amount of the casework in forensic controlled substances laboratories. In order to reduce the time of analysis for pharmaceuticals, a Direct Analysis in Real Time ion source coupled with an accurate mass time-of-flight (DART-TOF) mass spectrometer was used to confirm identity. DART-TOF spectral data for pharmaceutical samples were analyzed and evaluated by comparison to standard spectra. Identical mass pharmaceuticals were differentiated using collision induced dissociation fragmentation, present/absent ions, and abundance comparison box plots; principal component analysis (PCA) and linear discriminant analysis (LDA) were used for differentiation of identical mass mixed drug spectra. Mass assignment reproducibility and robustness tests were performed on the DART-TOF spectra. Impacts on the forensic science community include a decrease in analysis time over the traditional gas chromatograph/mass spectrometry (GC/MS) confirmations, better laboratory efficiency, and simpler sample preparation. Using physical identifiers and the DART-TOF to confirm pharmaceutical identity will eliminate the use of GC/MS and effectively reduce analysis time while still complying with accepted analysis protocols. This will prove helpful in laboratories with large backlogs and will simplify the confirmation process.

  5. 30 CFR 18.11 - Approval plate.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... extension(s) of approval were based. (d) A completely assembled approved machine with an integral dust collector shall bear an approval plate indicating that the requirements of part 33 of this chapter...

  6. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  7. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  8. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  9. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  10. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  11. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  12. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  13. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  14. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  15. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  16. 40 CFR 52.1073 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1073 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves Maryland's plans for...

  17. Updated treatment algorithm of pulmonary arterial hypertension.

    PubMed

    Galiè, Nazzareno; Corris, Paul A; Frost, Adaani; Girgis, Reda E; Granton, John; Jing, Zhi Cheng; Klepetko, Walter; McGoon, Michael D; McLaughlin, Vallerie V; Preston, Ioana R; Rubin, Lewis J; Sandoval, Julio; Seeger, Werner; Keogh, Anne

    2013-12-24

    The demands on a pulmonary arterial hypertension (PAH) treatment algorithm are multiple and in some ways conflicting. The treatment algorithm usually includes different types of recommendations with varying degrees of scientific evidence. In addition, the algorithm is required to be comprehensive but not too complex, informative yet simple and straightforward. The type of information in the treatment algorithm are heterogeneous including clinical, hemodynamic, medical, interventional, pharmacological and regulatory recommendations. Stakeholders (or users) including physicians from various specialties and with variable expertise in PAH, nurses, patients and patients' associations, healthcare providers, regulatory agencies and industry are often interested in the PAH treatment algorithm for different reasons. These are the considerable challenges faced when proposing appropriate updates to the current evidence-based treatment algorithm.The current treatment algorithm may be divided into 3 main areas: 1) general measures, supportive therapy, referral strategy, acute vasoreactivity testing and chronic treatment with calcium channel blockers; 2) initial therapy with approved PAH drugs; and 3) clinical response to the initial therapy, combination therapy, balloon atrial septostomy, and lung transplantation. All three sections will be revisited highlighting information newly available in the past 5 years and proposing updates where appropriate. The European Society of Cardiology grades of recommendation and levels of evidence will be adopted to rank the proposed treatments. PMID:24355643

  18. Update on rufinamide in childhood epilepsy.

    PubMed

    Coppola, Giangennaro

    2011-01-01

    Rufinamide is an orally active, structurally novel compound (1-[(2,6-difluorophenil1) methyl1]-1 hydro 1,2,3-triazole-4 carboxamide), which is structurally distinct from other anticonvulsant drugs. It was granted orphan drug status for the adjunctive treatment of Lennox-Gastaut syndrome (LGS) in the United States in 2004, and released for use in Europe in 2007. In January 2009, rufinamide was approved by the United States Food and Drug Administration for treatment of LGS in children 4 years of age and older. It is also approved for adjunctive treatment for partial seizures in adults and adolescents. Rufinamide's efficacy mainly against atonic/tonic seizures in patients with LGS seems nowadays indubitable and has been confirmed both in randomized controlled trial and in open label extension studies. More recently, rufinamide was evaluated for the adjunctive treatment of childhood-onset epileptic encephalopathies and epileptic syndromes other than LGS, including epileptic spasms, multifocal epileptic encephalopathy with spasm/tonic seizures, myoclonic-astatic epilepsy, Dravet syndrome and malignant migrating partial seizures in infancy. This review updates the existing literature data on the efficacy and safety/tolerability of rufinamide in childhood-onset epilepsy syndromes. PMID:21792306

  19. Update on rufinamide in childhood epilepsy

    PubMed Central

    Coppola, Giangennaro

    2011-01-01

    Rufinamide is an orally active, structurally novel compound (1-[(2,6-difluorophenil1) methyl1]-1 hydro 1,2,3-triazole-4 carboxamide), which is structurally distinct from other anticonvulsant drugs. It was granted orphan drug status for the adjunctive treatment of Lennox-Gastaut syndrome (LGS) in the United States in 2004, and released for use in Europe in 2007. In January 2009, rufinamide was approved by the United States Food and Drug Administration for treatment of LGS in children 4 years of age and older. It is also approved for adjunctive treatment for partial seizures in adults and adolescents. Rufinamide’s efficacy mainly against atonic/tonic seizures in patients with LGS seems nowadays indubitable and has been confirmed both in randomized controlled trial and in open label extension studies. More recently, rufinamide was evaluated for the adjunctive treatment of childhood-onset epileptic encephalopathies and epileptic syndromes other than LGS, including epileptic spasms, multifocal epileptic encephalopathy with spasm/tonic seizures, myoclonic-astatic epilepsy, Dravet syndrome and malignant migrating partial seizures in infancy. This review updates the existing literature data on the efficacy and safety/tolerability of rufinamide in childhood-onset epilepsy syndromes. PMID:21792306

  20. Sequence History Update Tool

    NASA Technical Reports Server (NTRS)

    Khanampompan, Teerapat; Gladden, Roy; Fisher, Forest; DelGuercio, Chris

    2008-01-01

    The Sequence History Update Tool performs Web-based sequence statistics archiving for Mars Reconnaissance Orbiter (MRO). Using a single UNIX command, the software takes advantage of sequencing conventions to automatically extract the needed statistics from multiple files. This information is then used to populate a PHP database, which is then seamlessly formatted into a dynamic Web page. This tool replaces a previous tedious and error-prone process of manually editing HTML code to construct a Web-based table. Because the tool manages all of the statistics gathering and file delivery to and from multiple data sources spread across multiple servers, there is also a considerable time and effort savings. With the use of The Sequence History Update Tool what previously took minutes is now done in less than 30 seconds, and now provides a more accurate archival record of the sequence commanding for MRO.

  1. Sensors, Update 12

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Fedder, Gary K.; Korvink, Jan G.

    2003-04-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Each volume is divided into three sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  2. Sensors, Update 8

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Göpel, Wolfgang; Hesse, Joachim

    2001-02-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Each volume is divided into three sections: Sensor Technology reviews highlights in applied and basic research, while Sensor Applications covers new or improved applications of sensors, and Sensor Markets provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be invaluable to scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  3. Sensors, Update 2

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Göpel, Wolfgang; Hesse, Joachim

    1996-10-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Furthermore, the sensor market as well as peripheral aspects such as standards are covered. Each volume is divided into four sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  4. Sensors, Update 11

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Fedder, Gary K.; Korvink, Jan G.

    2003-03-01

    Sensors Update ensures that you stay at the cutting edge of the field, presenting the current highlights of sensor and related microelectromechanical systems technology. Coverage includes most recent developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles based on micro- and nanotechnology. Each volume is divided into three sections: Sensor Technology reviews highlights in applied and basic research, Sensor Applications covers new or improved applications of sensors and Sensor Markets provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update is of must-have value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  5. Sensors, Update 1

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Göpel, Wolfgang; Hesse, Joachim

    1996-12-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Treatments include current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Furthermore, the sensor market as well as peripheral aspects such as standards are covered. Each volume is divided into four sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides an overview of suppliers and market trends for a particular section, and Sensor Standards, reviews recent legislation and requirements for sensors. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  6. Sensors, Update 10

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Fedder, Gary K.; Korvink, Jan G.

    2002-04-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Each volume is divided into three sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  7. Sensors, Update 9

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Göpel, Wolfgang; Hesse, Joachim

    2001-10-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Each volume is divided into three sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  8. SIM-Lite Update

    NASA Technical Reports Server (NTRS)

    Shao, Michael

    2008-01-01

    Discussion focus on: SIM-Lite Instrument Update - 6m baseline, 50cm, approximately 900M cost; Technology Update - Systematic errors and floor; SIM-Lite terrestrial planet discovery capability; Double blind multiple planet study summary; and the changing landscape of exoplanet science and the role of SIM-Lite. Slides include technology to flight component engineering; instrumental systematic errors; ultra deep search for Earth clones; double blind test, astrometric detection of Earths in multiplanet systems; the current era of exoplanet science and where SIM-Lite fits in; the next frontier and where SIM-Lite fits in, why SIM is unique in discovering Earths; imaging planet status is uncertain without masses and ages; SIM role in establishing how planetary systems form and evolve; and SIM probes of broad planet mass range around young stars.

  9. DSS command software update

    NASA Technical Reports Server (NTRS)

    Stinnett, W. G.

    1980-01-01

    The modifications, additions, and testing results for a version of the Deep Space Station command software, generated for support of the Voyager Saturn encounter, are discussed. The software update requirements included efforts to: (1) recode portions of the software to permit recovery of approximately 2000 words of memory; (2) correct five Voyager Ground data System liens; (3) provide capability to automatically turn off the command processor assembly local printer during periods of low activity; and (4) correct anomalies existing in the software.

  10. SLC classification: an update.

    PubMed

    Schlessinger, A; Yee, S W; Sali, A; Giacomini, K M

    2013-07-01

    The 386 human SLC superfamily members are diverse in sequence, structure, and function. Using sequence similarity, we previously classified the SLC superfamily members and identified relationships among families. With the recent determination of new SLC structures and identification of previously unknown human SLC families, an update of our previous classification is timely. Here, we comprehensively compare the SLC sequences and structures and discuss the applicability of structure-based ligand discovery to key SLC members.

  11. Using 'big data' to validate claims made in the pharmaceutical approval process.

    PubMed

    Wasser, Thomas; Haynes, Kevin; Barron, John; Cziraky, Mark

    2015-01-01

    Big Data in the healthcare setting refers to the storage, assimilation, and analysis of large quantities of information regarding patient care. These data can be collected and stored in a wide variety of ways including electronic medical records collected at the patient bedside, or through medical records that are coded and passed to insurance companies for reimbursement. When these data are processed it is possible to validate claims as a part of the regulatory review process regarding the anticipated performance of medications and devices. In order to analyze properly claims by manufacturers and others, there is a need to express claims in terms that are testable in a timeframe that is useful and meaningful to formulary committees. Claims for the comparative benefits and costs, including budget impact, of products and devices need to be expressed in measurable terms, ideally in the context of submission or validation protocols. Claims should be either consistent with accessible Big Data or able to support observational studies where Big Data identifies target populations. Protocols should identify, in disaggregated terms, key variables that would lead to direct or proxy validation. Once these variables are identified, Big Data can be used to query massive quantities of data in the validation process. Research can be passive or active in nature. Passive, where the data are collected retrospectively; active where the researcher is prospectively looking for indicators of co-morbid conditions, side-effects or adverse events, testing these indicators to determine if claims are within desired ranges set forth by the manufacturer. Additionally, Big Data can be used to assess the effectiveness of therapy through health insurance records. This, for example, could indicate that disease or co-morbid conditions cease to be treated. Understanding the basic strengths and weaknesses of Big Data in the claim validation process provides a glimpse of the value that this research can provide to industry. Big Data can support a research agenda that focuses on the process of claims validation to support formulary submissions as well as inputs to ongoing disease area and therapeutic class reviews.

  12. How Documentalists Update SIMBAD

    NASA Astrophysics Data System (ADS)

    Buga, M.; Bot, C.; Brouty, M.; Bruneau, C.; Brunet, C.; Cambresy, L.; Eisele, A.; Genova, F.; Lesteven, S.; Loup, C.; Neuville, M.; Oberto, A.; Ochsenbein, F.; Perret, E.; Siebert, A.; Son, E.; Vannier, P.; Vollmer, B.; Vonflie, P.; Wenger, M.; Woelfel, F.

    2015-04-01

    The Strasbourg astronomical Data Center (CDS) was created in 1972 and has had a major role in astronomy for more than forty years. CDS develops a service called SIMBAD that provides basic data, cross-identifications, bibliography, and measurements for astronomical objects outside the solar system. It brings to the scientific community an added value to content which is updated daily by a team of documentalists working together in close collaboration with astronomers and IT specialists. We explain how the CDS staff updates SIMBAD with object citations in the main astronomical journals, as well as with astronomical data and measurements. We also explain how the identification is made between the objects found in the literature and those already existing in SIMBAD. We show the steps followed by the documentalist team to update the database using different tools developed at CDS, like the sky visualizer Aladin, and the large catalogues and survey database VizieR. As a direct result of this teamwork, SIMBAD integrates almost 10.000 bibliographic references per year. The service receives more than 400.000 queries per day.

  13. The economics of pharmaceutical supply in Tanzania.

    PubMed

    Yudkin, J S

    1980-01-01

    This paper analyzes the patterns of purchasing, distribution, and utilization of pharmaceuticals currently found in Tanzania, an underdeveloped country in Africa. Like other nations in the Third World, Tanzania offers the prospect of a rapidly expanding market for the multinational pharmaceutical industry. However, this market has been to a large extent developed by the intense promotional activities of the drug companies themselves. In addition to normal marketing methods, these companies indulge in techniques which would be neither acceptable nor legal in developed countries. As a result, expensive proprietary drugs are overpurchased and overprescribed, mainly in the large urban hospitals, with consequent deprivation of other health care facilities, particularly those for the rural peasants who form the majority of the population. The activities of the multinational pharmaceutical companies in the Third World are therefore an important component in the continuing underdevelopment of health in these nations.

  14. Thermal properties of food and pharmaceutical powders

    NASA Astrophysics Data System (ADS)

    Abiad, Mohamad Ghassan

    Foods and pharmaceuticals are complex systems usually exposed to various environmental conditions during processing and thus storage, stability, functionality and quality are key attributes that deserve careful attention. The quality and stability of foods and pharmaceuticals are mainly affected by environmental conditions such as temperature, humidity, time, and processing conditions (e.g. shear, pressure) under which they may undergo physical and/or chemical transformations. Glass transition as well as other thermal properties is a key to understand how external conditions affect physical changes of such materials. Development of new materials and understanding the physico-chemical behavior of existing ones require a scientific foundation that translates into safe and high quality foods, improved quality of pharmaceuticals and nutraceuticals with lower risk to patients and functional efficacy of polymers used in food and medicinal products. This research provides an overview of the glass transition and other thermal properties and introduces novel methods developed to characterize such properties.

  15. Marketing concepts for pharmaceutical service development.

    PubMed

    Grauer, D W

    1981-02-01

    Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers.

  16. Pharmaceutical strategy and innovation: an academics perspective.

    PubMed

    Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K

    2007-06-01

    The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences.

  17. Biosimilars approval process.

    PubMed

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier.

  18. WHO Expert Committee on specifications for pharmaceutical preparations.

    PubMed

    2010-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file.

  19. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2009-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products; procedure for prequalification of pharmaceutical products; and the procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products.

  20. Terahertz study on porosity and mass fraction of active pharmaceutical ingredient of pharmaceutical tablets.

    PubMed

    Bawuah, Prince; Tan, Nicholas; Tweneboah, Samuel Nana A; Ervasti, Tuomas; Axel Zeitler, J; Ketolainen, Jarkko; Peiponen, Kai-Erik

    2016-08-01

    In this study, terahertz time-domain spectroscopic (THz-TDS) technique has been used to ascertain the change in the optical properties, as a function of changing porosity and mass fraction of active pharmaceutical ingredient (API), of training sets of pharmaceutical tablets. Four training sets of pharmaceutical tablets were compressed with microcrystalline cellulose (MCC) excipient and indomethacin API by varying either the porosity, height, and API mass fraction or all three tablet parameters. It was observed, as far as we know, for the first time, that the THz time-domain and frequency-domain effective refractive index, as well as, the frequency-domain effective absorption coefficient both show linear correlations with the porosity and API mass fraction for training sets of real pharmaceutical tablets. We suggest that, the observed linear correlations can be useful in basic research and quality inspection of pharmaceutical tablets. Additionally, we propose a novel optical strain parameter, based on THz measurement, which yields information on the conventional strain parameter of a tablet as well as on the change of fill fraction of solid material during compression of porous pharmaceutical tablets. We suggest that the THz measurement and proposed method of data analysis, in addition to providing an efficient tool for basic research of porous media, can serve as one of the novel quality by design (QbD) implementation techniques to predict critical quality attributes (CQA) such as porosity, API mass fraction and strain of flat-faced pharmaceutical tablets before production. PMID:27288937

  1. Capillary zone electrophoresis in pharmaceutical analysis.

    PubMed

    Fanali, S; Cristalli, M; Nardi, A; Ossicini, L; Shukla, S K

    1990-06-01

    The paper presents a brief characterization of capillary zone electrophoresis, a modern analytical separation method with high expediency for practical applications, especially in pharmaceutical analysis. Basic theoretical considerations are presented and discussed to explain the effects of the operational parameters upon the separation efficiency and resolution of species. Descriptions of simple instrumentation and of the analytical procedure itself are given. Experimental examples are given of the separation of mixtures of pharmaceutically important compounds and of the effects of operational parameters, especially pH of BGE and voltage applied. Lastly, the practical application of CZE for analysis of isoxsuprine in commercial preparations is shown.

  2. Pharmaceutical patent law: the Canadian perspective.

    PubMed

    Aumand, Livia; Norman, John

    2016-07-01

    This article provides an overview of the patent regime in Canada, with a focus on issues most relevant to the pharmaceutical industry. The process of applying for a patent is discussed, as well as enforcement and litigation. Recent developments in the case law dealing with patentability requirements - novelty, obviousness, utility and sufficiency - are reviewed. Finally, the impact of recently negotiated trade agreements on Canadian patent law is addressed. In this article, we aim to provide an overview of the patent regime in Canada, with a focus on issues that are particularly relevant to the pharmaceutical industry. PMID:27346187

  3. Pharmaceutical patent law: the Canadian perspective.

    PubMed

    Aumand, Livia; Norman, John

    2016-07-01

    This article provides an overview of the patent regime in Canada, with a focus on issues most relevant to the pharmaceutical industry. The process of applying for a patent is discussed, as well as enforcement and litigation. Recent developments in the case law dealing with patentability requirements - novelty, obviousness, utility and sufficiency - are reviewed. Finally, the impact of recently negotiated trade agreements on Canadian patent law is addressed. In this article, we aim to provide an overview of the patent regime in Canada, with a focus on issues that are particularly relevant to the pharmaceutical industry.

  4. Pharmaceutical regulation in the single European market.

    PubMed

    Matthews, D; Wilson, C

    1998-01-01

    This paper assesses the impact of new EU-wide drug authorisation procedures. The paper examines various attempts to introduce harmonised market authorisation routes for pharmaceuticals including the establishment of the multi-state, concentration, decentralised and centralised procedures. The paper considers the current role of the European Medicines Evaluation Agency and the likelihood that its powers will be increased in the future. Finally, the paper assesses whether EU regulation has created beneficial market conditions for pharmaceutical companies operating in the single European market. PMID:9922630

  5. Pharmaceutical regulation in the single European market.

    PubMed

    Matthews, D; Wilson, C

    1998-01-01

    This paper assesses the impact of new EU-wide drug authorisation procedures. The paper examines various attempts to introduce harmonised market authorisation routes for pharmaceuticals including the establishment of the multi-state, concentration, decentralised and centralised procedures. The paper considers the current role of the European Medicines Evaluation Agency and the likelihood that its powers will be increased in the future. Finally, the paper assesses whether EU regulation has created beneficial market conditions for pharmaceutical companies operating in the single European market.

  6. A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

    PubMed

    DiMasi, J A; Hermann, J C; Twyman, K; Kondru, R K; Stergiopoulos, S; Getz, K A; Rackoff, W

    2015-11-01

    We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology drugs from the top 50 pharmaceutical companies (2006 sales) that first entered clinical development from 1999 to 2007, had been taken to at least phase II development, and had a known final outcome (research abandonment or regulatory marketing approval). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Logistic regression and machine-learning methods were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors. We found that a simple four-factor model (activity, number of patients in the pivotal phase II trial, phase II duration, and a prevalence-related measure) had high sensitivity and specificity for predicting regulatory marketing approval. PMID:26239772

  7. Recent drug approvals from the US FDA and EMEA: what the future holds.

    PubMed

    Pevarello, Paolo

    2009-04-01

    The decreased productivity of the pharmaceutical industry in terms of new medical entities approved by the US FDA and the European Medicines Agency (EMEA) on a yearly basis has long been debated. This review will analyze overall new drug applications (NDAs) approved by both the FDA and EMEA in 2007, with the aim of finding trends (also looking at the past) that can be used to predict what the future may be. After a general introduction to the regulatory terminology, NDA approvals in 2007 are divided into categories (new applications of old medicines, metabolites, enantiomers and prodrugs, biological products, natural products and small organic molecule new molecular entities) and discussed. General aspects of the NDA approvals, such as historical trends, the length of the drug-discovery process, geography, differences among therapeutic areas, and the relative role of biotech and pharma industries are also outlined. From this analysis, a perspective is gained on some aspects that will probably influence future drug approvals. The conclusion is that 2007 may represent an inflexion point, in terms of quality if not quantity of new approvals, and that the future may be brighter than previously forecast.

  8. Restrictions on pharmaceutical detailing reduced off-label prescribing of antidepressants and antipsychotics in children.

    PubMed

    Larkin, Ian; Ang, Desmond; Avorn, Jerry; Kesselheim, Aaron S

    2014-06-01

    The treatment of pediatric depression is controversial because it includes substantial prescribing of drugs for uses that have not been approved by the Food and Drug Administration ("off label") and are not evidence based. Some academic medical centers (AMCs) restrict "detailing" by pharmaceutical sales representatives, or the promoting of drugs directly to physicians via sales calls, to reduce the effect of such marketing on physician prescribing. With data from thirty-one geographically diverse AMCs and their affiliated hospitals, we used a difference-in-differences model to estimate the effect of anti-detailing policies on off-label prescribing of antidepressants and antipsychotics by pediatricians and by child and adolescent psychiatrists in the period January 2006-June 2009. We found that after the introduction of such policies, prescriptions for off-label use of promoted drugs fell by 11 percent, consistent with the ongoing presence of off-label marketing to physicians. Prescriptions for on-label use of promoted drugs fell by 34 percent after the adoption of the policies. Conversely, prescriptions for on-label use of nonpromoted drugs rose by 14 percent, and those for off-label use of nonpromoted drugs rose by 35 percent. These results suggest that pharmaceutical sales representatives promoted drugs not approved for pediatric use and that policies that restrict detailing by those representatives reduced such off-label prescribing. PMID:24889951

  9. Drugs Approved for Pancreatic Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  10. Drugs Approved for Wilms Tumor

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  11. Drugs Approved for Bladder Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  12. Drugs Approved for Kaposi Sarcoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  13. Drugs Approved for Malignant Mesothelioma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. FDA-Approved HIV Medicines

    MedlinePlus

    ... and acronyms) Brand Name FDA Approval Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, an enzyme HIV ... AZT, ZDV) Retrovir March 19, 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter reverse ...

  15. Drugs Approved for Skin Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  16. Drugs Approved for Vaginal Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  17. Drugs Approved for Lung Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  18. Gaining approval for clinical research.

    PubMed

    Cobb, Vanessa; Srinivasan, Neil; Lambiase, Pier

    2016-07-01

    Set-up and delivery of a clinical research project can be complicated and difficult. This article introduces the regulatory processes involved in gaining approval for clinical research and discusses the obstacles that may be encountered. PMID:27388381

  19. Drugs Approved for Penile Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  20. Drugs Approved for Vulvar Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  1. Drugs Approved for Liver Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  2. Drugs Approved for Bone Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  3. Drugs Approved for Esophageal Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  4. Drugs Approved for Endometrial Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  5. Drugs Approved for Breast Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for breast cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  6. 99M-technetium labeled macroaggregated human serum albumin pharmaceutical

    DOEpatents

    Winchell, Harry S.; Barak, Morton; Van Fleet, III, Parmer

    1977-05-17

    A reagent comprising macroaggregated human serum albumin having dispersed therein particles of stannous tin and a method for instantly making a labeled pharmaceutical therefrom, are disclosed. The labeled pharmaceutical is utilized in organ imaging.

  7. Teaching Pharmaceutical Biotechnology at the University of Illinois at Chicago.

    ERIC Educational Resources Information Center

    Groves, Michael J.; Klegerman, Melvin E.

    1988-01-01

    The Department of Pharmaceutics at the University of Illinois at Chicago has been carrying out research in pharmaceutical biotechnology that has allowed unique student involvement and promises further interdisciplinary research and instructional activities. (MSE)

  8. Risks to aquatic organisms posed by human pharmaceutical use

    EPA Science Inventory

    In order to help prioritize future research efforts within the US, risks associated with exposure to human prescription pharmaceutical residues in wastewater were estimated from marketing and pharmacological data. Masses of 371 active pharmaceutical ingredients (APIs) dispensed ...

  9. Predicting variability of aquatic concentrations of human pharmaceuticals

    EPA Science Inventory

    Potential exposure to active pharmaceutical ingredients (APIs) in the aquatic environment is a subject of ongoing concern. We recently estimated maximum likely potency-normalized exposure rates at the national level for several hundred commonly used human prescription pharmaceut...

  10. NON-TRADITIONAL RESPONSES TO PHARMACEUTICALS IN AQUATIC ECOSYSTEMS

    EPA Science Inventory

    Quantitation of human and veterinary pharmaceuticals in environmental matrices has resulted in pharmaceuticals in the environment receiving unprecedented attention from the scientific community. Aquatic hazard assessments often use quantitative structure activity relationships an...

  11. Chitinases: An update

    PubMed Central

    Hamid, Rifat; Khan, Minhaj A.; Ahmad, Mahboob; Ahmad, Malik Mobeen; Abdin, Malik Zainul; Musarrat, Javed; Javed, Saleem

    2013-01-01

    Chitin, the second most abundant polysaccharide in nature after cellulose, is found in the exoskeleton of insects, fungi, yeast, and algae, and in the internal structures of other vertebrates. Chitinases are enzymes that degrade chitin. Chitinases contribute to the generation of carbon and nitrogen in the ecosystem. Chitin and chitinolytic enzymes are gaining importance for their biotechnological applications, especially the chitinases exploited in agriculture fields to control pathogens. Chitinases have a use in human health care, especially in human diseases like asthma. Chitinases have wide-ranging applications including the preparation of pharmaceutically important chitooligosaccharides and N-acetyl D glucosamine, preparation of single-cell protein, isolation of protoplasts from fungi and yeast, control of pathogenic fungi, treatment of chitinous waste, mosquito control and morphogenesis, etc. In this review, the various types of chitinases and the chitinases found in different organisms such as bacteria, plants, fungi, and mammals are discussed. PMID:23559820

  12. Digital mammography. Why hasn't it been approved for U.S. hospitals?

    PubMed

    2000-01-01

    Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective. PMID:10631559

  13. Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: treatments in urologic oncology.

    PubMed

    Ning, Yang-Min; Maher, V Ellen

    2015-03-01

    Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA's role in the development of investigational new drugs, with an emphasis on the regulatory process and the requirements for marketing approval. In addition, this review summarizes the products for the treatment of urologic malignancies that were approved by the FDA in the last 30 years and the key issues concerning urologic oncology products that were discussed publicly at Oncologic Drug Advisory Committee meetings in the past 10 years.

  14. Pharmaceutical Applications of Ion-Exchange Resins

    ERIC Educational Resources Information Center

    Elder, David

    2005-01-01

    The historical uses of ion-exchanged resins and a summary of the basic chemical principles involved in the ion-exchanged process are discussed. Specific applications of ion-exchange are provided that include drug stabilization, pharmaceutical excipients, taste-masking agents, oral sustained-release products, topical products for local application…

  15. New pharmaceuticals in inflammatory bowel disease

    PubMed Central

    Łodyga, Michał; Eder, Piotr; Bartnik, Witold; Gonciarz, Maciej; Kłopocka, Maria; Linke, Krzysztof; Małecka-Panas, Ewa; Radwan, Piotr

    2015-01-01

    This paper complements the previously published Guidelines of the Working Group of the Polish Society of Gastroenterology and former National Consultant in Gastroenterology regarding the management of patients with Crohn's disease and ulcerative colitis. Attention was focused on the new pharmaceutical recently registered for inflammatory bowel disease treatment. PMID:26557934

  16. Electrostatics of Pharmaceutical Aerosols for Pulmonary Delivery.

    PubMed

    Lip Kwok, Philip Chi

    2015-01-01

    This paper provides a review on key research findings in the rapidly developing area of pharmaceutical aerosol electrostatics. Solids and liquids can become charged without electric fields, the former by contact or friction and the latter by flowing or spraying. Therefore, charged particles and droplets carrying net charges are produced from pharmaceutical inhalers (e.g. dry powder inhalers, metered dose inhalers, and nebulisers) due to the mechanical processes involved in aerosolisation. The charging depends on many physicochemical factors, such as formulation composition, solid state properties, inhaler material and design, and relative humidity. In silico, in vitro, and limited in vivo studies have shown that electrostatic charges may potentially influence particle deposition in the airways. However, the evidence is not yet conclusive. Furthermore, there are currently no regulatory requirements on the characterisation and control of the electrostatic properties of inhaled formulations. Besides the need for further investigations on the relationship between physicochemical factors and charging characteristics of the aerosols, controlled and detailed in vivo studies are also required to confirm whether charges can affect particle deposition in the airways. Since pharmaceutical aerosol electrostatics is a relatively new research area, much remains to be explored. Thus there is certainly potential for development. New findings in the future may contribute to the advancement of pharmaceutical aerosol formulations and respiratory drug delivery.

  17. Pharmaceutical drugs chatter on Online Social Networks.

    PubMed

    Wiley, Matthew T; Jin, Canghong; Hristidis, Vagelis; Esterling, Kevin M

    2014-06-01

    The ubiquity of Online Social Networks (OSNs) is creating new sources for healthcare information, particularly in the context of pharmaceutical drugs. We aimed to examine the impact of a given OSN's characteristics on the content of pharmaceutical drug discussions from that OSN. We compared the effect of four distinguishing characteristics from ten different OSNs on the content of their pharmaceutical drug discussions: (1) General versus Health OSN; (2) OSN moderation; (3) OSN registration requirements; and (4) OSNs with a question and answer format. The effects of these characteristics were measured both quantitatively and qualitatively. Our results show that an OSN's characteristics indeed affect the content of its discussions. Based on their information needs, healthcare providers may use our findings to pick the right OSNs or to advise patients regarding their needs. Our results may also guide the creation of new and more effective domain-specific health OSNs. Further, future researchers of online healthcare content in OSNs may find our results informative while choosing OSNs as data sources. We reported several findings about the impact of OSN characteristics on the content of pharmaceutical drug discussion, and synthesized these findings into actionable items for both healthcare providers and future researchers of healthcare discussions on OSNs. Future research on the impact of OSN characteristics could include user demographics, quality and safety of information, and efficacy of OSN usage. PMID:24637141

  18. Deep pharma: psychiatry, anthropology, and pharmaceutical detox.

    PubMed

    Oldani, Michael

    2014-06-01

    Psychiatric medication, or psychotropics, are increasingly prescribed for people of all ages by both psychiatry and primary care doctors for a multitude of mental health and/or behavioral disorders, creating a sharp rise in polypharmacy (i.e., multiple medications). This paper explores the clinical reality of modern psychotropy at the level of the prescribing doctor and clinical exchanges with patients. Part I, Geographies of High Prescribing, documents the types of factors (pharmaceutical-promotional, historical, cultural, etc.) that can shape specific psychotropic landscapes. Ethnographic attention is focused on high prescribing in Japan in the 1990s and more recently in the Upper Peninsula of Michigan, in the US. These examples help to identify factors that have converged over time to produce specific kinds of branded psychotropic profiles in specific locales. Part II, Pharmaceutical Detox, explores a new kind of clinical work being carried out by pharmaceutically conscious doctors, which reduces the number of medications being prescribed to patients while re-diagnosing their mental illnesses. A high-prescribing psychiatrist in southeast Wisconsin is highlighted to illustrate a kind of med-checking taking place at the level of individual patients. These various examples and cases call for a renewed emphasis by anthropology to critically examine the "total efficacies" of modern pharmaceuticals and to continue to disaggregate mental illness categories in the Boasian tradition. This type of detox will require a holistic approach, incorporating emergent fields such as neuroanthropology and other kinds of creative collaborations. PMID:24700144

  19. [Archeology of the radio pharmaceutical advertisement].

    PubMed

    Lefebvre, Thierry

    2002-01-01

    After Second World War, a debate sets in France the partisans and the detractors of the radio advertisement, in particular pharmaceutical advertisement. In this article, the author revises campaigns led, during the thirties, by Robert Desnos for Armand Salacrou. PMID:12731488

  20. Electrostatics of Pharmaceutical Aerosols for Pulmonary Delivery.

    PubMed

    Lip Kwok, Philip Chi

    2015-01-01

    This paper provides a review on key research findings in the rapidly developing area of pharmaceutical aerosol electrostatics. Solids and liquids can become charged without electric fields, the former by contact or friction and the latter by flowing or spraying. Therefore, charged particles and droplets carrying net charges are produced from pharmaceutical inhalers (e.g. dry powder inhalers, metered dose inhalers, and nebulisers) due to the mechanical processes involved in aerosolisation. The charging depends on many physicochemical factors, such as formulation composition, solid state properties, inhaler material and design, and relative humidity. In silico, in vitro, and limited in vivo studies have shown that electrostatic charges may potentially influence particle deposition in the airways. However, the evidence is not yet conclusive. Furthermore, there are currently no regulatory requirements on the characterisation and control of the electrostatic properties of inhaled formulations. Besides the need for further investigations on the relationship between physicochemical factors and charging characteristics of the aerosols, controlled and detailed in vivo studies are also required to confirm whether charges can affect particle deposition in the airways. Since pharmaceutical aerosol electrostatics is a relatively new research area, much remains to be explored. Thus there is certainly potential for development. New findings in the future may contribute to the advancement of pharmaceutical aerosol formulations and respiratory drug delivery. PMID:26290198