49 CFR 219.701 - Standards for drug and alcohol testing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Standards for drug and alcohol testing. 219.701... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Drug and Alcohol Testing Procedures § 219.701 Standards for drug and alcohol testing. (a) Drug testing required or authorized by subparts B...

49 CFR 219.701 - Standards for drug and alcohol testing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Standards for drug and alcohol testing. 219.701... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Drug and Alcohol Testing Procedures § 219.701 Standards for drug and alcohol testing. (a) Drug testing required or authorized by subparts B...

49 CFR 219.701 - Standards for drug and alcohol testing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Standards for drug and alcohol testing. 219.701... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Drug and Alcohol Testing Procedures § 219.701 Standards for drug and alcohol testing. (a) Drug testing required or authorized by subparts B...

75 FR 5722 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-04

... drugs in a DOT drug test. You must not test ``DOT specimens'' for any other drugs. (a) Marijuana... test analyte concentration analyte concentration Marijuana metabolites 50 ng/mL THCA \\1\\ 15 ng/mL...

49 CFR 199.117 - Recordkeeping.

Code of Federal Regulations, 2011 CFR

2011-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing... provided by DOT Procedures. Statistical data related to drug testing and rehabilitation that is not name... employee drug test that indicate a verified positive result, records that demonstrate compliance with the...

49 CFR 199.117 - Recordkeeping.

Code of Federal Regulations, 2013 CFR

2013-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing... provided by DOT Procedures. Statistical data related to drug testing and rehabilitation that is not name... employee drug test that indicate a verified positive result, records that demonstrate compliance with the...

49 CFR 199.117 - Recordkeeping.

Code of Federal Regulations, 2012 CFR

2012-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing... provided by DOT Procedures. Statistical data related to drug testing and rehabilitation that is not name... employee drug test that indicate a verified positive result, records that demonstrate compliance with the...

49 CFR 199.117 - Recordkeeping.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing... provided by DOT Procedures. Statistical data related to drug testing and rehabilitation that is not name... employee drug test that indicate a verified positive result, records that demonstrate compliance with the...

49 CFR 199.117 - Recordkeeping.

Code of Federal Regulations, 2014 CFR

2014-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing... provided by DOT Procedures. Statistical data related to drug testing and rehabilitation that is not name... employee drug test that indicate a verified positive result, records that demonstrate compliance with the...

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 1 2010-10-01 2010-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 1 2014-10-01 2014-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 1 2012-10-01 2012-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 1 2013-10-01 2013-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 1 2011-10-01 2011-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

28 CFR 35.131 - Illegal use of drugs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... participation to individuals who engage in illegal use of drugs while they are in the program. (c) Drug testing... procedures, including but not limited to drug testing, designed to ensure that an individual who formerly... of testing for the illegal use of drugs. ...

Validation protocol of analytical procedures for quantification of drugs in polymeric systems for parenteral administration: dexamethasone phosphate disodium microparticles.

PubMed

Martín-Sabroso, Cristina; Tavares-Fernandes, Daniel Filipe; Espada-García, Juan Ignacio; Torres-Suárez, Ana Isabel

2013-12-15

In this work a protocol to validate analytical procedures for the quantification of drug substances formulated in polymeric systems that comprise both drug entrapped into the polymeric matrix (assay:content test) and drug released from the systems (assay:dissolution test) is developed. This protocol is applied to the validation two isocratic HPLC analytical procedures for the analysis of dexamethasone phosphate disodium microparticles for parenteral administration. Preparation of authentic samples and artificially "spiked" and "unspiked" samples is described. Specificity (ability to quantify dexamethasone phosphate disodium in presence of constituents of the dissolution medium and other microparticle constituents), linearity, accuracy and precision are evaluated, in the range from 10 to 50 μg mL(-1) in the assay:content test procedure and from 0.25 to 10 μg mL(-1) in the assay:dissolution test procedure. The robustness of the analytical method to extract drug from microparticles is also assessed. The validation protocol developed allows us to conclude that both analytical methods are suitable for their intended purpose, but the lack of proportionality of the assay:dissolution analytical method should be taken into account. The validation protocol designed in this work could be applied to the validation of any analytical procedure for the quantification of drugs formulated in controlled release polymeric microparticles. Copyright © 2013 Elsevier B.V. All rights reserved.

10 CFR 707.10 - Drug testing for reasonable suspicion of illegal drug use.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Drug testing for reasonable suspicion of illegal drug use... Procedures § 707.10 Drug testing for reasonable suspicion of illegal drug use. (a)(1) It may be necessary to... relating to the testing for the use of illegal drugs are not intended to prohibit the contractor from...

10 CFR 707.10 - Drug testing for reasonable suspicion of illegal drug use.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Drug testing for reasonable suspicion of illegal drug use... Procedures § 707.10 Drug testing for reasonable suspicion of illegal drug use. (a)(1) It may be necessary to... relating to the testing for the use of illegal drugs are not intended to prohibit the contractor from...

10 CFR 707.10 - Drug testing for reasonable suspicion of illegal drug use.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Drug testing for reasonable suspicion of illegal drug use... Procedures § 707.10 Drug testing for reasonable suspicion of illegal drug use. (a)(1) It may be necessary to... relating to the testing for the use of illegal drugs are not intended to prohibit the contractor from...

10 CFR 707.10 - Drug testing for reasonable suspicion of illegal drug use.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Drug testing for reasonable suspicion of illegal drug use... Procedures § 707.10 Drug testing for reasonable suspicion of illegal drug use. (a)(1) It may be necessary to... relating to the testing for the use of illegal drugs are not intended to prohibit the contractor from...

10 CFR 707.10 - Drug testing for reasonable suspicion of illegal drug use.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Drug testing for reasonable suspicion of illegal drug use... Procedures § 707.10 Drug testing for reasonable suspicion of illegal drug use. (a)(1) It may be necessary to... relating to the testing for the use of illegal drugs are not intended to prohibit the contractor from...

49 CFR 40.205 - How are drug test problems corrected?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false How are drug test problems corrected? 40.205 Section 40.205 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.205 How are drug test problems corrected? (a) As a collector, you have the...

10 CFR 707.7 - Random drug testing requirements and identification of testing designated positions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Random drug testing requirements and identification of... PROGRAMS AT DOE SITES Procedures § 707.7 Random drug testing requirements and identification of testing... evidence of the use of illegal drugs of employees in testing designated positions identified in this...

10 CFR 707.7 - Random drug testing requirements and identification of testing designated positions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Random drug testing requirements and identification of... PROGRAMS AT DOE SITES Procedures § 707.7 Random drug testing requirements and identification of testing... evidence of the use of illegal drugs of employees in testing designated positions identified in this...

10 CFR 707.7 - Random drug testing requirements and identification of testing designated positions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Random drug testing requirements and identification of... PROGRAMS AT DOE SITES Procedures § 707.7 Random drug testing requirements and identification of testing... evidence of the use of illegal drugs of employees in testing designated positions identified in this...

10 CFR 707.7 - Random drug testing requirements and identification of testing designated positions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Random drug testing requirements and identification of... PROGRAMS AT DOE SITES Procedures § 707.7 Random drug testing requirements and identification of testing... evidence of the use of illegal drugs of employees in testing designated positions identified in this...

10 CFR 707.7 - Random drug testing requirements and identification of testing designated positions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Random drug testing requirements and identification of... PROGRAMS AT DOE SITES Procedures § 707.7 Random drug testing requirements and identification of testing... evidence of the use of illegal drugs of employees in testing designated positions identified in this...

Employee Drug Testing Policies in Police Departments. Research in Brief.

ERIC Educational Resources Information Center

McEwen, J. Thomas; And Others

1986-01-01

The development of drug testing policies and the implementation of drug testing procedures involve legal, ethical, medical, and labor relations issues. To learn how police departments are addressing the problem of drug use and drug testing of police officers, the National Institute of Justice sponsored a telephone survey of 33 major police…

49 CFR 40.160 - What does the MRO do when a valid test result cannot be produced and a negative result is required?

Code of Federal Regulations, 2010 CFR

2010-10-01

... determine if there is clinical evidence that the individual is currently an illicit drug user. You must make... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS...., blood) as part of the medically appropriate procedures in determining clinical evidence of drug use. (d...

10 CFR 707.8 - Applicant drug testing.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Applicant drug testing. 707.8 Section 707.8 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.8 Applicant drug testing. An applicant for a testing designated position will be tested for the use of illegal drugs before...

10 CFR 707.8 - Applicant drug testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Applicant drug testing. 707.8 Section 707.8 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.8 Applicant drug testing. An applicant for a testing designated position will be tested for the use of illegal drugs before...

10 CFR 707.8 - Applicant drug testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Applicant drug testing. 707.8 Section 707.8 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.8 Applicant drug testing. An applicant for a testing designated position will be tested for the use of illegal drugs before...

Prime-, Stress- and Cue-Induced Reinstatement of Extinguished Drug-Reinforced Responding in Rats: Cocaine as the Prototypical Drug of Abuse

PubMed Central

Beardsley, Patrick M.; Shelton, Keith L.

2012-01-01

This unit describes the testing of rats in prime-, footshock- and cue-induced reinstatement procedures. Evaluating rats in these procedures enables the assessment of treatments on behavior thought to model drug relapse precipitated by re-contact with an abused drug (prime-induced), induced by stress (footshock-induced), or by stimuli previously associated with drug administration (cue-induced). For instance, levels of reinstatement under the effects of test compound administration could be compared to levels under vehicle administration to help identify potential treatments for drug relapse, or reinstatement levels of different rat strains could be compared to identify potential genetic determinants of perseverative drug-seeking behavior. Cocaine is used as a prototypical drug of abuse, and relapse to its use serves as the model in this unit, but other self-administered drugs could readily be substituted with little modification to the procedures. PMID:23093352

49 CFR 40.113 - Where is other information concerning laboratories found in this regulation?

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.113... specimen tests (drugs). § 40.179—Role of second laboratory in split specimen tests (adulterants). § 40.181...

49 CFR 40.113 - Where is other information concerning laboratories found in this regulation?

Code of Federal Regulations, 2014 CFR

2014-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.113... specimen tests (drugs). § 40.179—Role of second laboratory in split specimen tests (adulterants). § 40.181...

49 CFR 40.113 - Where is other information concerning laboratories found in this regulation?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.113... specimen tests (drugs). § 40.179—Role of second laboratory in split specimen tests (adulterants). § 40.181...

49 CFR 40.113 - Where is other information concerning laboratories found in this regulation?

Code of Federal Regulations, 2013 CFR

2013-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.113... specimen tests (drugs). § 40.179—Role of second laboratory in split specimen tests (adulterants). § 40.181...

49 CFR 40.113 - Where is other information concerning laboratories found in this regulation?

Code of Federal Regulations, 2012 CFR

2012-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.113... specimen tests (drugs). § 40.179—Role of second laboratory in split specimen tests (adulterants). § 40.181...

28 CFR 36.209 - Illegal use of drugs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the program. (c) Drug testing. (1) This part does not prohibit a public accommodation from adopting or administering reasonable policies or procedures, including but not limited to drug testing, designed to ensure..., restrict, or authorize the conducting of testing for the illegal use of drugs. ...

49 CFR 40.199 - What problems always cause a drug test to be cancelled?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What problems always cause a drug test to be cancelled? 40.199 Section 40.199 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.199 What problems always cause a drug test to be cancelled? (a...

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2014 CFR

2014-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2012 CFR

2012-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2013 CFR

2013-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2010 CFR

2010-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2011 CFR

2011-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

21 CFR 660.26 - Specificity tests and avidity tests.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Specificity tests and avidity tests. 660.26 Section 660.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... using test procedures approved by the Director, Center for Biologics Evaluation and Research. [53 FR...

49 CFR 40.203 - What problems cause a drug test to be cancelled unless they are corrected?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What problems cause a drug test to be cancelled unless they are corrected? 40.203 Section 40.203 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.203 What problems cause a drug test to be...

49 CFR 40.191 - What is a refusal to take a DOT drug test, and what are the consequences?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false What is a refusal to take a DOT drug test, and... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.191 What is a refusal to take a DOT drug test, and what are the consequences? (a) As an employee...

49 CFR 40.191 - What is a refusal to take a DOT drug test, and what are the consequences?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What is a refusal to take a DOT drug test, and... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.191 What is a refusal to take a DOT drug test, and what are the consequences? (a) As an employee...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2012 CFR

2012-04-01

... forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual active... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Procedures for classifying OTC drugs as generally...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2013 CFR

2013-04-01

... setting forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Procedures for classifying OTC drugs as generally...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2011 CFR

2011-04-01

... forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual active... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Procedures for classifying OTC drugs as generally...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2010 CFR

2010-04-01

... forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual active... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Procedures for classifying OTC drugs as generally...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2014 CFR

2014-04-01

... setting forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Procedures for classifying OTC drugs as generally...

Newborn drug testing practices in Iowa birthing hospitals.

PubMed

Wood, K E; Smith, P; Krasowski, M D

2017-01-01

Federal law mandates states to have policies and procedures to identify newborns exposed to maternal substance use during pregnancy. National guidelines for newborn drug testing are lacking; therefore, procedures are variable and determined by state law and local practices. In Iowa, maternal substance use during pregnancy is considered child abuse and must be reported.The objective of this study was to identify newborn drug testing policies and procedures among birthing hospitals in Iowa. This was a cross sectional survey of all birthing hospitals in Iowa identified via the Statewide Perinatal Care Program. An electronic survey was sent to the representative at each affiliated hospital. Sixty-nine of 76 hospitals completed the survey for a 90.8% response rate. Newborn drug testing is ordered in 97.1% of responding hospitals with most testing 25% or less of newborns annually. The majority utilized a risk assessment tool (89.6%), although many (62.7%) also allowed for provider discretion. No hospital performed universal testing of all newborns. 86.6% of hospitals reported all positive newborn drug test results including illicit and/or prescription drugs to child protective services. 35.0% of hospitals notified mothers of the report and 45.5% offered substance abuse services and/or treatment to the mothers. Most Iowa birthing hospitals perform newborn drug testing and report all positive test results to child protective services. The majority use risk assessment tools. Maternal notification practices and referral for substance use disorder treatment are suboptimal and represent an area for future improvement.

75 FR 13009 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-18

... DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 [Docket DOT-OST-2008-0088] RIN OST 2105-AD84 Procedures for Transportation Workplace Drug and Alcohol Testing Programs Correction In rule document 2010-3731 beginning on page 8528 in the issue of Thursday, February 25, 2010, make the...

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2014 CFR

2014-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2012 CFR

2012-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

10 CFR 707.13 - Medical review of results of tests for illegal drug use.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Medical review of results of tests for illegal drug use... Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be submitted for medical review by the MRO. A confirmed positive test for drugs shall consist of an initial...

49 CFR 40.197 - What happens when an employer receives a report of a dilute specimen?

Code of Federal Regulations, 2011 CFR

2011-10-01

... retests in pre-employment situations, but not in random test situations). You must inform your employees... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.197... informs you that a positive drug test was dilute, you simply treat the test as a verified positive test...

49 CFR 40.197 - What happens when an employer receives a report of a dilute specimen?

Code of Federal Regulations, 2013 CFR

2013-10-01

... retests in pre-employment situations, but not in random test situations). You must inform your employees... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.197... informs you that a positive drug test was dilute, you simply treat the test as a verified positive test...

49 CFR 40.95 - What are the adulterant cutoff concentrations for initial and confirmation tests?

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the cutoff concentrations for the initial and confirmation adulterant testing as...

49 CFR 40.95 - What are the adulterant cutoff concentrations for initial and confirmation tests?

Code of Federal Regulations, 2011 CFR

2011-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the cutoff concentrations for the initial and confirmation adulterant testing as...

49 CFR 40.95 - What are the adulterant cutoff concentrations for initial and confirmation tests?

Code of Federal Regulations, 2013 CFR

2013-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the cutoff concentrations for the initial and confirmation adulterant testing as...

49 CFR 40.95 - What are the adulterant cutoff concentrations for initial and confirmation tests?

Code of Federal Regulations, 2014 CFR

2014-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the cutoff concentrations for the initial and confirmation adulterant testing as...

49 CFR 40.95 - What are the adulterant cutoff concentrations for initial and confirmation tests?

Code of Federal Regulations, 2010 CFR

2010-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the cutoff concentrations for the initial and confirmation adulterant testing as...

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

49 CFR 219.611 - Test result indicating prohibited alcohol concentration; procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.611 Test result indicating prohibited alcohol...

76 FR 18072 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

... DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 Procedures for Transportation Workplace Drug and Alcohol Testing Programs CFR Correction In Title 49 of the Code of Federal Regulations, Parts 1 to 99, revised as of October 1, 2010, on page 571, in Sec. 40.97, add paragraphs (a)(2)(i) and...

Drug Testing.

ERIC Educational Resources Information Center

Legal Memorandum, 1987

1987-01-01

A number of legal issues are involved in conducting a drug testing program to determine whether students--and occasionally teachers--are using illegal drugs. Two legal issues have been raised concerning the accuracy of the urinalysis test: whether it is chemically accurate and whether appropriate procedures have been followed to make certain that…

49 CFR 40.103 - What are the requirements for submitting blind specimens to a laboratory?

Code of Federal Regulations, 2013 CFR

2013-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.103... specimens you submit must be negative (i.e., containing no drugs, nor adulterated or substituted). Approximately 15 percent must be positive for one or more of the five drugs involved in DOT tests, and...

49 CFR 40.103 - What are the requirements for submitting blind specimens to a laboratory?

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.103... specimens you submit must be negative (i.e., containing no drugs, nor adulterated or substituted). Approximately 15 percent must be positive for one or more of the five drugs involved in DOT tests, and...

49 CFR 40.103 - What are the requirements for submitting blind specimens to a laboratory?

Code of Federal Regulations, 2014 CFR

2014-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.103... specimens you submit must be negative (i.e., containing no drugs, nor adulterated or substituted). Approximately 15 percent must be positive for one or more of the five drugs involved in DOT tests, and...

49 CFR 40.103 - What are the requirements for submitting blind specimens to a laboratory?

Code of Federal Regulations, 2012 CFR

2012-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.103... specimens you submit must be negative (i.e., containing no drugs, nor adulterated or substituted). Approximately 15 percent must be positive for one or more of the five drugs involved in DOT tests, and...

49 CFR 40.103 - What are the requirements for submitting blind specimens to a laboratory?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.103... specimens you submit must be negative (i.e., containing no drugs, nor adulterated or substituted). Approximately 15 percent must be positive for one or more of the five drugs involved in DOT tests, and...

Rapid identification of illegal synthetic adulterants in herbal anti-diabetic medicines using near infrared spectroscopy

NASA Astrophysics Data System (ADS)

Feng, Yanchun; Lei, Deqing; Hu, Changqin

We created a rapid detection procedure for identifying herbal medicines illegally adulterated with synthetic drugs using near infrared spectroscopy. This procedure includes a reverse correlation coefficient method (RCCM) and comparison of characteristic peaks. Moreover, we made improvements to the RCCM based on new strategies for threshold settings. Any tested herbal medicine must meet two criteria to be identified with our procedure as adulterated. First, the correlation coefficient between the tested sample and the reference must be greater than the RCCM threshold. Next, the NIR spectrum of the tested sample must contain the same characteristic peaks as the reference. In this study, four pure synthetic anti-diabetic drugs (i.e., metformin, gliclazide, glibenclamide and glimepiride), 174 batches of laboratory samples and 127 batches of herbal anti-diabetic medicines were used to construct and validate the procedure. The accuracy of this procedure was greater than 80%. Our data suggest that this protocol is a rapid screening tool to identify synthetic drug adulterants in herbal medicines on the market.

An efficient early phase 2 procedure to screen medications for efficacy in smoking cessation.

PubMed

Perkins, Kenneth A; Lerman, Caryn

2014-01-01

Initial screening of new medications for potential efficacy (i.e., Food and Drug Administration (FDA) early phase 2), such as in aiding smoking cessation, should be efficient in identifying which drugs do, or do not, warrant more extensive (and expensive) clinical testing. This focused review outlines our research on development, evaluation, and validation of an efficient crossover procedure for sensitivity in detecting medication efficacy for smoking cessation. First-line FDA-approved medications of nicotine patch, varenicline, and bupropion were tested as model drugs, in three separate placebo-controlled studies. We also tested specificity of our procedure in identifying a drug that lacks efficacy, using modafinil. This crossover procedure showed sensitivity (increased days of abstinence) during week-long "practice" quit attempts with each of the active cessation medications (positive controls) versus placebo, but not with modafinil (negative control) versus placebo, as hypothesized. Sensitivity to medication efficacy signal was observed only in smokers high in intrinsic quit motivation (i.e., already preparing to quit soon) and not smokers low in intrinsic quit motivation, even if monetarily reinforced for abstinence (i.e., given extrinsic motivation). A crossover procedure requiring less time and fewer subjects than formal trials may provide an efficient strategy for a go/no-go decision whether to advance to subsequent phase 2 randomized clinical trials with a novel drug. Future research is needed to replicate our results and evaluate this procedure with novel compounds, identify factors that may limit its utility, and evaluate its applicability to testing efficacy of compounds for treating other forms of addiction.

21 CFR 212.60 - What requirements apply to the laboratories where I test components, in-process materials, and...

Code of Federal Regulations, 2010 CFR

2010-04-01

... I test components, in-process materials, and finished PET drug products? 212.60 Section 212.60 Food... materials, and finished PET drug products? (a) Testing procedures. Each laboratory used to conduct testing of components, in-process materials, and finished PET drug products must have and follow written...

49 CFR 40.201 - What problems always cause a drug test to be cancelled and may result in a requirement for...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What problems always cause a drug test to be cancelled and may result in a requirement for another collection? 40.201 Section 40.201 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.201 Wha...

49 CFR 40.275 - What is the effect of procedural problems that are not sufficient to cancel an alcohol test?

Code of Federal Regulations, 2010 CFR

2010-10-01

... not sufficient to cancel an alcohol test? 40.275 Section 40.275 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Alcohol Testing § 40.275 What is the effect of procedural problems that are not sufficient to...

49 CFR 40.275 - What is the effect of procedural problems that are not sufficient to cancel an alcohol test?

Code of Federal Regulations, 2014 CFR

2014-10-01

... not sufficient to cancel an alcohol test? 40.275 Section 40.275 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Alcohol Testing § 40.275 What is the effect of procedural problems that are not sufficient to...

49 CFR 40.275 - What is the effect of procedural problems that are not sufficient to cancel an alcohol test?

Code of Federal Regulations, 2011 CFR

2011-10-01

... not sufficient to cancel an alcohol test? 40.275 Section 40.275 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Alcohol Testing § 40.275 What is the effect of procedural problems that are not sufficient to...

49 CFR 40.275 - What is the effect of procedural problems that are not sufficient to cancel an alcohol test?

Code of Federal Regulations, 2012 CFR

2012-10-01

... not sufficient to cancel an alcohol test? 40.275 Section 40.275 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Alcohol Testing § 40.275 What is the effect of procedural problems that are not sufficient to...

49 CFR 40.275 - What is the effect of procedural problems that are not sufficient to cancel an alcohol test?

Code of Federal Regulations, 2013 CFR

2013-10-01

... not sufficient to cancel an alcohol test? 40.275 Section 40.275 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Alcohol Testing § 40.275 What is the effect of procedural problems that are not sufficient to...

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2012 CFR

2012-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2011 CFR

2011-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2013 CFR

2013-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2014 CFR

2014-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2010 CFR

2010-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

10 CFR 707.13 - Medical review of results of tests for illegal drug use.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

10 CFR 707.13 - Medical review of results of tests for illegal drug use.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

10 CFR 707.13 - Medical review of results of tests for illegal drug use.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

10 CFR 707.13 - Medical review of results of tests for illegal drug use.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

Inhalation and dermal exposure to eight antineoplastic drugs in an industrial laundry facility.

PubMed

Fransman, Wouter; Huizer, Daan; Tuerk, Jochen; Kromhout, Hans

2007-04-01

The aims of the study were to quantify levels of dermal and inhalation exposure to antineoplastic drugs in an industrial laundry service in the Netherlands and to test the removal efficiency of the washing procedure for removal of antineoplastic drugs. During four workdays dermal and inhalation exposure to eight frequently used antineoplastic drugs (cyclophosphamide, ifosfamide, methotrexate, 5-fluorouracil, etoposide, cytarabine, gemcitabine and chlorambucil) were measured for all job titles involved in handling unwashed laundry. To test the removal efficiency of the washing procedure, 10 x 10 cm sections were excised before and after the washing procedure. These sections were taken from 15 bed sheets that were collected in hospitals of patients who were treated with one of the selected antineoplastic drugs. During none of the four measurement days, detectable levels of any of the eight antineoplastic drugs (cyclophosphamide, ifosfamide, methotrexate, 5-fluorouracil, etoposide, cytarabine, gemcitabine, or chlorambucil) were found on workers' skin of hands or in any of the air samples. Only four out of the 15 bed sheets from patients that were treated with antineoplastic drugs appeared to be contaminated with detectable levels of antineoplastic drugs before the washing procedure (range 13.0-3,060 ng/100 cm(2)). After the pre-washing and after the complete washing procedure, no detectable levels of any of the eight antineoplastic drugs were found anymore in the selected bed sheets. The implementation of guidelines for working with antineoplastic drugs seems to be successful in reducing exposure to antineoplastic drugs of workers in this laundry facility to an acceptable, non-detectable level and to remove antineoplastic drug contamination from bed linen.

Documentation forms for monitoring occupational surveillance of healthcare workers who handle cytotoxic drugs.

PubMed

Parillo, V L

1994-01-01

To develop a procedure for medical surveillance of healthcare workers who handle cytotoxic drugs. Literature review and guidelines published by the Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health. INFORMATION SELECTION: Studies of possible exposure screening tests, congenital defects in offspring, and case studies. Some degree of risk exists in handling cytotoxic drugs, but no reliable screening test for cytotoxic drug exposure has been developed. Reproductive hazards are possible when protective equipment is not used. Areas to be addressed when devising surveillance procedures include who to cover, what baseline data to gather, what periodic monitoring will be necessary (and at what interval it will be conducted), how to handle exposure incidents, and what documentation system will be used. A procedure using a baseline risk factor form and a yearly monitoring questionnaire was devised and implemented. Forms contain documentation of worker teaching. Most often, nurses are the healthcare workers who handle cytotoxic drugs. A consistent approach to monitoring healthcare workers is facilitated by using a defined procedure and standardized forms.

Knowledge and Attitudes of Drug Usage. Grades 4-12.

ERIC Educational Resources Information Center

Instructional Objectives Exchange, Los Angeles, CA.

This collection of cognitive and affective objectives, and related measurement instruments, concerns knowledge of and attitudes toward prescription drugs, tobacco, alcohol, and illegal drugs. It describes procedures used in developing, field testing, administering, and scoring the tests. Objectives are listed by grade range: secondary (grades…

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2013 CFR

2013-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2013-10-01 2013-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2011-10-01 2011-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2010-10-01 2010-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2012 CFR

2012-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2012-10-01 2012-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2014 CFR

2014-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2014-10-01 2014-10-01 false What is validity testing, and are laboratories...

Drug Testing in Schools: Implications for Policy.

ERIC Educational Resources Information Center

Bozeman, William C.; And Others

1987-01-01

Public concern about substance abuse, fueled by political and media attention, is causing school administrators to consider a variety of approaches beyond traditional drug education. No procedures, methods, or rules regarding drug testing should be established in the absence of clear school board policy, and no policy decisions should be made…

49 CFR 40.96 - What criteria do laboratories use to establish that a specimen is invalid?

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the invalid test result criteria for the initial and confirmation testing as... whether sending the specimen to another HHS certified laboratory for testing would be useful in being able...

49 CFR 40.96 - What criteria do laboratories use to establish that a specimen is invalid?

Code of Federal Regulations, 2010 CFR

2010-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the invalid test result criteria for the initial and confirmation testing as... whether sending the specimen to another HHS certified laboratory for testing would be useful in being able...

49 CFR 40.96 - What criteria do laboratories use to establish that a specimen is invalid?

Code of Federal Regulations, 2013 CFR

2013-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the invalid test result criteria for the initial and confirmation testing as... whether sending the specimen to another HHS certified laboratory for testing would be useful in being able...

49 CFR 40.96 - What criteria do laboratories use to establish that a specimen is invalid?

Code of Federal Regulations, 2011 CFR

2011-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the invalid test result criteria for the initial and confirmation testing as... whether sending the specimen to another HHS certified laboratory for testing would be useful in being able...

49 CFR 40.96 - What criteria do laboratories use to establish that a specimen is invalid?

Code of Federal Regulations, 2014 CFR

2014-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing... laboratory, you must use the invalid test result criteria for the initial and confirmation testing as... whether sending the specimen to another HHS certified laboratory for testing would be useful in being able...

49 CFR 40.129 - What are the MRO's functions in reviewing laboratory confirmed non-negative drug test results?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What are the MRO's functions in reviewing laboratory confirmed non-negative drug test results? 40.129 Section 40.129 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Proces...

49 CFR 40.15 - May an employer use a service agent to meet DOT drug and alcohol testing requirements?

Code of Federal Regulations, 2010 CFR

2010-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Employer Responsibilities § 40.15 May an employer use a service agent to meet DOT drug and alcohol testing requirements? (a... 49 Transportation 1 2010-10-01 2010-10-01 false May an employer use a service agent to meet DOT...

29 CFR 1630.3 - Exceptions to the definitions of “Disability” and “Qualified Individual with a Disability.”

Code of Federal Regulations, 2014 CFR

2014-07-01

... procedures, including but not limited to drug testing, designed to ensure that an individual described in...) Drug testing). (d) Disability does not include: (1) Transvestism, transsexualism, pedophilia... do not include individuals currently engaging in the illegal use of drugs, when the covered entity...

29 CFR 1630.3 - Exceptions to the definitions of “Disability” and “Qualified Individual with a Disability.”

Code of Federal Regulations, 2013 CFR

2013-07-01

... procedures, including but not limited to drug testing, designed to ensure that an individual described in...) Drug testing). (d) Disability does not include: (1) Transvestism, transsexualism, pedophilia... do not include individuals currently engaging in the illegal use of drugs, when the covered entity...

29 CFR 1630.3 - Exceptions to the definitions of “Disability” and “Qualified Individual with a Disability.”

Code of Federal Regulations, 2010 CFR

2010-07-01

... procedures, including but not limited to drug testing, designed to ensure that an individual described in...) Drug testing). (d) Disability does not include: (1) Transvestism, transsexualism, pedophilia... do not include individuals currently engaging in the illegal use of drugs, when the covered entity...

29 CFR 1630.3 - Exceptions to the definitions of “Disability” and “Qualified Individual with a Disability.”

Code of Federal Regulations, 2011 CFR

2011-07-01

... procedures, including but not limited to drug testing, designed to ensure that an individual described in...) Drug testing). (d) Disability does not include: (1) Transvestism, transsexualism, pedophilia... do not include individuals currently engaging in the illegal use of drugs, when the covered entity...

29 CFR 1630.3 - Exceptions to the definitions of “Disability” and “Qualified Individual with a Disability.”

Code of Federal Regulations, 2012 CFR

2012-07-01

... procedures, including but not limited to drug testing, designed to ensure that an individual described in...) Drug testing). (d) Disability does not include: (1) Transvestism, transsexualism, pedophilia... do not include individuals currently engaging in the illegal use of drugs, when the covered entity...

10 CFR 26.127 - Procedures.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., implement, and maintain written standard operating procedures for each assay performed for drug and specimen... facility shall develop, implement, and maintain written standard operating procedures for each test. The...; (2) Preparation of reagents, standards, and controls; (3) Calibration procedures; (4) Derivation of...

10 CFR 26.127 - Procedures.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., implement, and maintain written standard operating procedures for each assay performed for drug and specimen... facility shall develop, implement, and maintain written standard operating procedures for each test. The...; (2) Preparation of reagents, standards, and controls; (3) Calibration procedures; (4) Derivation of...

10 CFR 26.127 - Procedures.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., implement, and maintain written standard operating procedures for each assay performed for drug and specimen... facility shall develop, implement, and maintain written standard operating procedures for each test. The...; (2) Preparation of reagents, standards, and controls; (3) Calibration procedures; (4) Derivation of...

49 CFR 40.165 - To whom does the MRO transmit reports of drug test results?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false To whom does the MRO transmit reports of drug test results? 40.165 Section 40.165 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.165 To whom does the MRO...

49 CFR 40.165 - To whom does the MRO transmit reports of drug test results?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false To whom does the MRO transmit reports of drug test results? 40.165 Section 40.165 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.165 To whom does the MRO...

49 CFR 40.321 - What is the general confidentiality rule for drug and alcohol test information?

Code of Federal Regulations, 2010 CFR

2010-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Confidentiality and...., other employers who are members of a C/TPA, companies to which the employee may apply for employment...

European guidelines for workplace drug and alcohol testing in hair.

PubMed

Salomone, A; Tsanaclis, L; Agius, R; Kintz, P; Baumgartner, M R

2016-10-01

Guidelines for Legally Defensible Workplace Drug Testing have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). They are based on the 2010 version published by Pascal Kintz and Ronald Agius (Guidelines for European workplace drug and alcohol testing in hair. Drug Test. Anal. 2010, 2, 367) and in concordance with the Society of Hair Testing guidelines (Society of Hair Testing guidelines for drug testing in hair. Forensic Sci. Int. 2012, 218, 20-24). The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing use these guidelines as a template for accreditation. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

49 CFR 40.209 - What procedural problems do not result in the cancellation of a test and do not require correction?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What procedural problems do not result in the... Problems in Drug Tests § 40.209 What procedural problems do not result in the cancellation of a test and do... aware, even if they are not considered problems that will cause a test to be cancelled as listed in this...

49 CFR 40.209 - What procedural problems do not result in the cancellation of a test and do not require correction?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false What procedural problems do not result in the... Problems in Drug Tests § 40.209 What procedural problems do not result in the cancellation of a test and do... aware, even if they are not considered problems that will cause a test to be cancelled as listed in this...

49 CFR 40.159 - What does the MRO do when a drug test result is invalid?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What does the MRO do when a drug test result is invalid? 40.159 Section 40.159 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.159 What does the MRO do when a...

75 FR 59105 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug Testing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... (the checkmark can pre-printed in the appropriate box on the CCF at Step 1-D). (h) Test reason, as appropriate: Pre-employment; Random; Reasonable Suspicion/Reasonable Cause; Post-Accident; Return-to-Duty; and... reason (e.g., random test, post-accident test) and DOT Agency (e.g., check DOT and FMCSA) as for the...

European guidelines for workplace drug testing in oral fluid.

PubMed

Brcak, Michaela; Beck, Olof; Bosch, Tessa; Carmichael, Duncan; Fucci, Nadia; George, Claire; Piper, Mark; Salomone, Alberto; Schielen, Wim; Steinmeyer, Stefan; Taskinen, Sanna; Weinmann, Wolfgang

2018-03-01

These guidelines for Legally Defensible Workplace Drug Testing have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing should use these guidelines as a template for accreditation. These guidelines are relevant to laboratory-based testing only. These guidelines follow current best practices and are constantly under review. Copyright © 2017 John Wiley & Sons, Ltd.

49 CFR 40.139 - On what basis does the MRO verify test results for codeine and morphine?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the... the case of other drugs (see § 40.137). Consumption of food products (e.g., poppy seeds) must not be...

49 CFR 40.139 - On what basis does the MRO verify test results for codeine and morphine?

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the... the case of other drugs (see § 40.137). Consumption of food products (e.g., poppy seeds) must not be...

49 CFR 40.105 - What happens if the laboratory reports a result different from that expected for a blind specimen?

Code of Federal Regulations, 2011 CFR

2011-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.105 What happens if the laboratory reports a result different from that expected...

49 CFR 40.105 - What happens if the laboratory reports a result different from that expected for a blind specimen?

Code of Federal Regulations, 2014 CFR

2014-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.105 What happens if the laboratory reports a result different from that expected...

49 CFR 40.105 - What happens if the laboratory reports a result different from that expected for a blind specimen?

Code of Federal Regulations, 2010 CFR

2010-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.105 What happens if the laboratory reports a result different from that expected...

49 CFR 40.105 - What happens if the laboratory reports a result different from that expected for a blind specimen?

Code of Federal Regulations, 2013 CFR

2013-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.105 What happens if the laboratory reports a result different from that expected...

49 CFR 40.105 - What happens if the laboratory reports a result different from that expected for a blind specimen?

Code of Federal Regulations, 2012 CFR

2012-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.105 What happens if the laboratory reports a result different from that expected...

Current Knowledge on Cannabinoids in Oral Fluid

PubMed Central

Lee, Dayong; Huestis, Marilyn A.

2015-01-01

Oral fluid (OF) is a new biological matrix for clinical and forensic drug testing, offering non-invasive and directly observable sample collection reducing adulteration potential, ease of multiple sample collections, lower biohazard risk during collection, recent exposure identification, and stronger correlation with blood than urine concentrations. Because cannabinoids are usually the most prevalent analytes in illicit drug testing, application of OF drug testing requires sufficient scientific data to support sensitive and specific OF cannabinoid detection. This review presents current knowledge on OF cannabinoids, evaluating pharmacokinetic properties, detection windows, and correlation with other biological matrices and impairment from field applications and controlled drug administration studies. In addition, on-site screening technologies, confirmatory analytical methods, drug stability, and effects of sample collection procedure, adulterants, and passive environmental exposure are reviewed. Delta-9-tetrahydrocannabinol OF concentrations could be > 1000 μg/L shortly after smoking, whereas minor cannabinoids are detected at 10-fold and metabolites at 1000-fold lower concentrations. OF research over the past decade demonstrated that appropriate interpretation of test results requires a comprehensive understanding of distinct elimination profiles and detection windows for different cannabinoids, which are influenced by administration route, dose, and drug use history. Thus, each drug testing program should establish cutoff criteria, collection/analysis procedures, and storage conditions tailored to its purposes. Building a scientific basis for OF testing is on-going, with continuing OF cannabinoids research on passive environmental exposure, drug use history, donor physiological conditions, and oral cavity metabolism needed to better understand mechanisms of cannabinoid OF disposition and expand OF drug testing applicability. PMID:23983217

21 CFR 352.50 - Principal display panel of all sunscreen drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... sunscreen product testing procedures in § 352.76. (1) (Select one of the following: “Water,” “Water/Sweat... product testing procedures in § 352.76. (1) “Very” (select one of the following: “Water,” “Water/Sweat...

21 CFR 352.50 - Principal display panel of all sunscreen drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... sunscreen product testing procedures in § 352.76. (1) (Select one of the following: “Water,” “Water/Sweat... product testing procedures in § 352.76. (1) “Very” (select one of the following: “Water,” “Water/Sweat...

21 CFR 352.50 - Principal display panel of all sunscreen drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... sunscreen product testing procedures in § 352.76. (1) (Select one of the following: “Water,” “Water/Sweat... product testing procedures in § 352.76. (1) “Very” (select one of the following: “Water,” “Water/Sweat...

21 CFR 352.50 - Principal display panel of all sunscreen drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... sunscreen product testing procedures in § 352.76. (1) (Select one of the following: “Water,” “Water/Sweat... product testing procedures in § 352.76. (1) “Very” (select one of the following: “Water,” “Water/Sweat...

21 CFR 352.50 - Principal display panel of all sunscreen drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... sunscreen product testing procedures in § 352.76. (1) (Select one of the following: “Water,” “Water/Sweat... product testing procedures in § 352.76. (1) “Very” (select one of the following: “Water,” “Water/Sweat...

PREDICTING ABUSE POTENTIAL OF STIMULANTS AND OTHER DOPAMINERGIC DRUGS: OVERVIEW AND RECOMMENDATIONS

PubMed Central

Huskinson, Sally L.; Naylor, Jennifer E.; Rowlett, James K.; Freeman, Kevin B.

2014-01-01

Examination of a drug’s abuse potential at multiple levels of analysis (molecular/cellular action, whole-organism behavior, epidemiological data) is an essential component to regulating controlled substances under the Controlled Substances Act (CSA). We reviewed studies that examined several central nervous system (CNS) stimulants, focusing on those with primarily dopaminergic actions, in drug self-administration, drug discrimination, and physical dependence. For drug self-administration and drug discrimination, we distinguished between experiments conducted with rats and nonhuman primates (NHP) to highlight the common and unique attributes of each model in the assessment of abuse potential. Our review of drug self-administration studies suggests that this procedure is important in predicting abuse potential of dopaminergic compounds, but there were many false positives. We recommended that tests to determine how reinforcing a drug is relative to a known drug of abuse may be more predictive of abuse potential than tests that yield a binary, yes-or-no classification. Several false positives also occurred with drug discrimination. With this procedure, we recommended that future research follow a standard decision-tree approach that may require examining the drug being tested for abuse potential as the training stimulus. This approach would also allow several known drugs of abuse to be tested for substitution, and this may reduce false positives. Finally, we reviewed evidence of physical dependence with stimulants and discussed the feasibility of modeling these phenomena in nonhuman animals in a rational and practical fashion. PMID:24662599

49 CFR 40.111 - When and how must a laboratory disclose statistical summaries and other information it maintains?

Code of Federal Regulations, 2012 CFR

2012-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.111 When and how must a laboratory disclose statistical summaries and other... a report indicating that not enough testing was conducted to warrant a summary. You may transmit the...

49 CFR 40.111 - When and how must a laboratory disclose statistical summaries and other information it maintains?

Code of Federal Regulations, 2014 CFR

2014-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.111 When and how must a laboratory disclose statistical summaries and other... a report indicating that not enough testing was conducted to warrant a summary. You may transmit the...

49 CFR 40.111 - When and how must a laboratory disclose statistical summaries and other information it maintains?

Code of Federal Regulations, 2011 CFR

2011-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.111 When and how must a laboratory disclose statistical summaries and other... a report indicating that not enough testing was conducted to warrant a summary. You may transmit the...

49 CFR 40.111 - When and how must a laboratory disclose statistical summaries and other information it maintains?

Code of Federal Regulations, 2013 CFR

2013-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.111 When and how must a laboratory disclose statistical summaries and other... a report indicating that not enough testing was conducted to warrant a summary. You may transmit the...

49 CFR 40.208 - What problem requires corrective action but does not result in the cancellation of a test?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What problem requires corrective action but does not result in the cancellation of a test? 40.208 Section 40.208 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests § 40.208 What problem requires...

49 CFR 40.195 - What happens when an individual is unable to provide a sufficient amount of urine for a pre...

Code of Federal Regulations, 2014 CFR

2014-10-01

... provide a sufficient amount of urine for a pre-employment follow-up or return-to-duty test because of a... providing a sufficient specimen for a pre-employment follow-up or return-to-duty test and the condition... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests...

49 CFR 40.195 - What happens when an individual is unable to provide a sufficient amount of urine for a pre...

Code of Federal Regulations, 2011 CFR

2011-10-01

... provide a sufficient amount of urine for a pre-employment follow-up or return-to-duty test because of a... providing a sufficient specimen for a pre-employment follow-up or return-to-duty test and the condition... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests...

49 CFR 40.195 - What happens when an individual is unable to provide a sufficient amount of urine for a pre...

Code of Federal Regulations, 2013 CFR

2013-10-01

... provide a sufficient amount of urine for a pre-employment follow-up or return-to-duty test because of a... providing a sufficient specimen for a pre-employment follow-up or return-to-duty test and the condition... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests...

49 CFR 40.195 - What happens when an individual is unable to provide a sufficient amount of urine for a pre...

Code of Federal Regulations, 2010 CFR

2010-10-01

... provide a sufficient amount of urine for a pre-employment follow-up or return-to-duty test because of a... providing a sufficient specimen for a pre-employment follow-up or return-to-duty test and the condition... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests...

49 CFR 40.195 - What happens when an individual is unable to provide a sufficient amount of urine for a pre...

Code of Federal Regulations, 2012 CFR

2012-10-01

... provide a sufficient amount of urine for a pre-employment follow-up or return-to-duty test because of a... providing a sufficient specimen for a pre-employment follow-up or return-to-duty test and the condition... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Problems in Drug Tests...

Predicting abuse potential of stimulants and other dopaminergic drugs: overview and recommendations.

PubMed

Huskinson, Sally L; Naylor, Jennifer E; Rowlett, James K; Freeman, Kevin B

2014-12-01

Examination of a drug's abuse potential at multiple levels of analysis (molecular/cellular action, whole-organism behavior, epidemiological data) is an essential component to regulating controlled substances under the Controlled Substances Act (CSA). We reviewed studies that examined several central nervous system (CNS) stimulants, focusing on those with primarily dopaminergic actions, in drug self-administration, drug discrimination, and physical dependence. For drug self-administration and drug discrimination, we distinguished between experiments conducted with rats and nonhuman primates (NHP) to highlight the common and unique attributes of each model in the assessment of abuse potential. Our review of drug self-administration studies suggests that this procedure is important in predicting abuse potential of dopaminergic compounds, but there were many false positives. We recommended that tests to determine how reinforcing a drug is relative to a known drug of abuse may be more predictive of abuse potential than tests that yield a binary, yes-or-no classification. Several false positives also occurred with drug discrimination. With this procedure, we recommended that future research follow a standard decision-tree approach that may require examining the drug being tested for abuse potential as the training stimulus. This approach would also allow several known drugs of abuse to be tested for substitution, and this may reduce false positives. Finally, we reviewed evidence of physical dependence with stimulants and discussed the feasibility of modeling these phenomena in nonhuman animals in a rational and practical fashion. This article is part of the Special Issue entitled 'CNS Stimulants'. Copyright © 2014 Elsevier Ltd. All rights reserved.

Principles and procedures in forensic toxicology.

PubMed

Wyman, John F

2012-09-01

The principles and procedures employed in a modern forensic toxicology lab are detailed in this review. Aspects of Behavioral and Postmortem toxicology, including certification of analysts and accreditation of labs, chain of custody requirements, typical testing services provided, rationale for specimen selection, and principles of quality assurance are discussed. Interpretation of toxicology results in postmortem specimens requires the toxicologist and pathologist to be cognizant of drug-drug interactions, drug polymorphisms and pharmacogenomics, the gross signs of toxic pathology, postmortem redistribution, confirmation of systemic toxicity in suspected overdoses, the possibility of developed tolerance, and the effects of decomposition on drug concentration.

21 CFR 320.36 - Requirements for maintenance of records of bioequivalence testing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.36 Requirements for...

49 CFR 199.5 - DOT procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING General § 199.5... to the requirements of this part and DOT Procedures. Terms and concepts used in this part have the...

Comparative Analyses of Zebrafish Anxiety-Like Behavior Using Conflict-Based Novelty Tests.

PubMed

Kysil, Elana V; Meshalkina, Darya A; Frick, Erin E; Echevarria, David J; Rosemberg, Denis B; Maximino, Caio; Lima, Monica Gomes; Abreu, Murilo S; Giacomini, Ana C; Barcellos, Leonardo J G; Song, Cai; Kalueff, Allan V

2017-06-01

Modeling of stress and anxiety in adult zebrafish (Danio rerio) is increasingly utilized in neuroscience research and central nervous system (CNS) drug discovery. Representing the most commonly used zebrafish anxiety models, the novel tank test (NTT) focuses on zebrafish diving in response to potentially threatening stimuli, whereas the light-dark test (LDT) is based on fish scototaxis (innate preference for dark vs. bright areas). Here, we systematically evaluate the utility of these two tests, combining meta-analyses of published literature with comparative in vivo behavioral and whole-body endocrine (cortisol) testing. Overall, the NTT and LDT behaviors demonstrate a generally good cross-test correlation in vivo, whereas meta-analyses of published literature show that both tests have similar sensitivity to zebrafish anxiety-like states. Finally, NTT evokes higher levels of cortisol, likely representing a more stressful procedure than LDT. Collectively, our study reappraises NTT and LDT for studying anxiety-like states in zebrafish, and emphasizes their developing utility for neurobehavioral research. These findings can help optimize drug screening procedures by choosing more appropriate models for testing anxiolytic or anxiogenic drugs.

The evaluation of the abuse liability of drugs.

PubMed

Johanson, C E

1990-01-01

In order to place appropriate restrictions upon the availability of certain therapeutic agents to limit their abuse, it is important to assess abuse liability, an important aspect of drug safety evaluation. However, the negative consequences of restriction must also be considered. Drugs most likely to be tested are psychoactive compounds with therapeutic indications similar to known drugs of abuse. Methods include assays of pharmacological profile, drug discrimination procedures, self-administration procedures, and measures of drug-induced toxicity including evaluations of tolerance and physical dependence. Furthermore, the evaluation of toxicity using behavioural end-points is an important component of the assessment, and it is generally believed that the most valid procedure in this evaluation is the measurement of drug self-administration. However, even this method rarely predicts the extent of abuse of a specific drug. Although methods are available which appear to measure relative abuse liability, these procedures are not validated for all drug classes. Thus, additional strategies, including abuse liability studies in humans, modelled after those used with animals, must be used in order to make a more informed prediction. Although there is pressure to place restrictions on new drugs at the time of marketing, in light of the difficulty of predicting relative abuse potential, a better strategy might be to market a drug without restrictions, but require postmarketing surveillance in order to obtain more accurate information on which to base a final decision.

49 CFR 40.109 - What documentation must the laboratory keep, and for how long?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What documentation must the laboratory keep, and for how long? 40.109 Section 40.109 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.109...

49 CFR 40.101 - What relationship may a laboratory have with an MRO?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What relationship may a laboratory have with an MRO? 40.101 Section 40.101 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.101 What relationship...

49 CFR 40.101 - What relationship may a laboratory have with an MRO?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What relationship may a laboratory have with an MRO? 40.101 Section 40.101 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.101 What relationship...

49 CFR 40.101 - What relationship may a laboratory have with an MRO?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false What relationship may a laboratory have with an MRO? 40.101 Section 40.101 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.101 What relationship...

49 CFR 40.109 - What documentation must the laboratory keep, and for how long?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false What documentation must the laboratory keep, and for how long? 40.109 Section 40.109 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.109...

49 CFR 40.101 - What relationship may a laboratory have with an MRO?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false What relationship may a laboratory have with an MRO? 40.101 Section 40.101 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.101 What relationship...

49 CFR 40.109 - What documentation must the laboratory keep, and for how long?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false What documentation must the laboratory keep, and for how long? 40.109 Section 40.109 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.109...

49 CFR 40.101 - What relationship may a laboratory have with an MRO?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false What relationship may a laboratory have with an MRO? 40.101 Section 40.101 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.101 What relationship...

49 CFR 40.109 - What documentation must the laboratory keep, and for how long?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false What documentation must the laboratory keep, and for how long? 40.109 Section 40.109 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.109...

49 CFR 40.109 - What documentation must the laboratory keep, and for how long?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What documentation must the laboratory keep, and for how long? 40.109 Section 40.109 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.109...

DynaMiTES - A dynamic cell culture platform for in vitro drug testing PART 2 - Ocular DynaMiTES for drug absorption studies of the anterior eye.

PubMed

Beiβner, Nicole; Mattern, Kai; Dietzel, Andreas; Reichl, Stephan

2018-05-01

In the present study, a formerly designed Dynamic Micro Tissue Engineering System (DynaMiTES) was applied with our prevalidated human hemicornea (HC) construct to obtain a test platform for improved absorption studies of the anterior eye (Ocular DynaMiTES). First, the cultivation procedure of the classic HC was slightly adapted to the novel DynaMiTES design. The obtained inverted HC was then compared to classic HC regarding cell morphology using light and scanning electron microscopy, cell viability using MTT dye reaction and epithelial barrier properties observing transepithelial electrical resistance and apparent permeation coefficient of sodium fluorescein. These tested cell criteria were similar. In addition, the effects of four different flow rates on the same cell characteristics were investigated using the DynaMiTES. Because no harmful potential of flow was found, dynamic absorption studies of sodium fluorescein with and without 0.005%, 0.01% and 0.02% benzalkonium chloride were performed compared to the common static test procedure. In this proof-of-concept study, the dynamic test conditions showed different results than the static test conditions with a better prediction of in vivo data. Thus, we propose that our DynaMiTES platform provides great opportunities for the improvement of common in vitro drug testing procedures. Copyright © 2017 Elsevier B.V. All rights reserved.

Development and characterization of a pre-treatment procedure to eliminate human monoclonal antibody therapeutic drug and matrix interference in cell-based functional neutralizing antibody assays.

PubMed

Xu, Weifeng; Jiang, Hao; Titsch, Craig; Haulenbeek, Jonathan R; Pillutla, Renuka C; Aubry, Anne-Françoise; DeSilva, Binodh S; Arnold, Mark E; Zeng, Jianing; Dodge, Robert W

2015-01-01

Biological therapeutics can induce an undesirable immune response resulting in the formation of anti-drug antibodies (ADA), including neutralizing antibodies (NAbs). Functional (usually cell-based) NAb assays are preferred to determine NAb presence in patient serum, but are often subject to interferences from numerous serum factors, such as growth factors and disease-related cytokines. Many functional cell-based NAb assays are essentially drug concentration assays that imply the presence of NAbs by the detection of small changes in functional drug concentration. Any drug contained in the test sample will increase the total amount of drug in the assay, thus reducing the sensitivity of NAb detection. Biotin-drug Extraction with Acid Dissociation (BEAD) has been successfully applied to extract ADA, thereby removing drug and other interfering factors from human serum samples. However, to date there has been no report to estimate the residual drug level after BEAD treatment when the drug itself is a human monoclonal antibody; mainly due to the limitation of traditional ligand-binding assays. Here we describe a universal BEAD optimization procedure for human monoclonal antibody (mAb) drugs by using a LC-MS/MS method to simultaneously measure drug (a mutant human IgG4), NAb positive control (a mouse IgG), and endogenous human IgGs as an indicator of nonspecific carry-over in the BEAD eluate. This is the first report demonstrating that residual human mAb drug level in clinical sample can be measured after BEAD pre-treatment, which is critical for further BEAD procedure optimization and downstream immunogenicity testing. Copyright © 2014 Elsevier B.V. All rights reserved.

21 CFR 110.80 - Processes and controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Processes and controls. 110.80 Section 110.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR... extraneous-material testing procedures shall be used where necessary to identify sanitation failures or...

21 CFR 110.80 - Processes and controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Processes and controls. 110.80 Section 110.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR... extraneous-material testing procedures shall be used where necessary to identify sanitation failures or...

21 CFR 110.80 - Processes and controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Processes and controls. 110.80 Section 110.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR... extraneous-material testing procedures shall be used where necessary to identify sanitation failures or...

Normalization of urinary drug concentrations with specific gravity and creatinine.

PubMed

Cone, Edward J; Caplan, Yale H; Moser, Frank; Robert, Tim; Shelby, Melinda K; Black, David L

2009-01-01

Excessive fluid intake can substantially dilute urinary drug concentrations and result in false-negative reports for drug users. Methods for correction ("normalization") of drug/metabolite concentrations in urine have been utilized by anti-doping laboratories, pain monitoring programs, and in environmental monitoring programs to compensate for excessive hydration, but such procedures have not been used routinely in workplace, legal, and treatment settings. We evaluated two drug normalization procedures based on specific gravity and creatinine. These corrections were applied to urine specimens collected from three distinct groups (pain patients, heroin users, and marijuana/ cocaine users). Each group was unique in characteristics, study design, and dosing conditions. The results of the two normalization procedures were highly correlated (r=0.94; range, 0.78-0.99). Increases in percent positives by specific gravity and creatinine normalization were small (0.3% and -1.0%, respectively) for heroin users (normally hydrated subjects), modest (4.2-9.8%) for pain patients (unknown hydration state), and substantial (2- to 38-fold increases) for marijuana/cocaine users (excessively hydrated subjects). Despite some limitations, these normalization procedures provide alternative means of dealing with highly dilute, dilute, and concentrated urine specimens. Drug/metabolite concentration normalization by these procedures is recommended for urine testing programs, especially as a means of coping with dilute specimens.

75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-02

... questions on impact-resistant lenses, including questions on test procedures, lens testing apparatus, record..., lens testing apparatus, record maintenance, and exemptions to testing. This document also contains more...

Does the Drug Facts Label for nonprescription drugs meet its design objectives? A new procedure for assessing label effectiveness

PubMed Central

Ryan, Michael P; Costello-White, Reagan N

2017-01-01

We demonstrate an expanded procedure for assessing drug-label comprehension. Innovations include a pretest of drug preconceptions, verbal ability and label attentiveness measures, a label-scanning task, a free-recall test, category-clustering measures, and preconception-change scores. In total, 55 female and 39 male undergraduates read a facsimile Drug Facts Label for aspirin, a Cohesive-Prose Label, or a Scrambled-Prose Label. The Drug Facts Label outperformed the Scrambled-Prose Label, but not the Cohesive-Prose Label, in scanning effectiveness. The Drug Facts Label was no better than the Cohesive-Prose Label or the Scrambled-Prose Label in promoting attentiveness, recall and organization of drug facts, or misconception refutation. Discussion focuses on the need for refutational labels based on a sequence-of-events text schema. PMID:29379613

Chemical dependency and drug testing in the workplace.

PubMed

Osterloh, J D; Becker, C E

1990-01-01

Urine testing for drug use in the workplace is now widespread, with the prevalence of positive drug tests in the work force being 0% to 15%. The prevalence of marijuana use is highest of the illicit drugs being tested. Highly prevalent drugs can be reliably tested. Although it is prudent to rid the workplace of drug use, there is little scientific study on the relationship of drug use and workplace outcomes, such as productivity and safety. Probable-cause testing and preemployment testing are the most common applications. Random testing has been less accepted owing to its higher costs, unresolved legal issues, and predictably poor test reliability. Legal issues have focused on the right to privacy, policy agreements, discrimination, and the lack of due process. The legal cornerstone of a good program is a policy that is planned and agreed on by both labor and management, which serves both as a contract and as a procedure in which expectations and consequences are known. Moreover, NIDA is certifying laboratories doing employee drug testing. Testing methods, when done correctly, are less prone to error than in the past, but screening tests can be defeated by adulterants. Although the incidence of false-positive results is low, such tests are less reliable when the prevalence of drug abuse is also low.

49 CFR 40.93 - What criteria do laboratories use to establish that a specimen is dilute or substituted?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What criteria do laboratories use to establish that a specimen is dilute or substituted? 40.93 Section 40.93 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing...

49 CFR 40.93 - What criteria do laboratories use to establish that a specimen is dilute or substituted?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false What criteria do laboratories use to establish that a specimen is dilute or substituted? 40.93 Section 40.93 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing...

49 CFR 40.93 - What criteria do laboratories use to establish that a specimen is dilute or substituted?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What criteria do laboratories use to establish that a specimen is dilute or substituted? 40.93 Section 40.93 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing...

49 CFR 40.93 - What criteria do laboratories use to establish that a specimen is dilute or substituted?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false What criteria do laboratories use to establish that a specimen is dilute or substituted? 40.93 Section 40.93 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing...

49 CFR 40.93 - What criteria do laboratories use to establish that a specimen is dilute or substituted?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false What criteria do laboratories use to establish that a specimen is dilute or substituted? 40.93 Section 40.93 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing...

75 FR 8526 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-25

... regarding the interim final rule (IFR) procedures for the use of a new alcohol screening device (ASD) which... for an employer to utilize a specific ASD to conduct required DOT alcohol tests, the device must (a... model specifications, (b) be published by NHTSA in the Federal Register on their most current ASD CPL...

Lorazepam reinstates punishment-suppressed remifentanil self-administration in rats.

PubMed

Panlilio, Leigh V; Thorndike, Eric B; Schindler, Charles W

2005-05-01

We recently described a reinstatement procedure that models relapse to drug abuse in cases where abstinence results from aversive consequences of drug use. The potential value of this punishment-based model of relapse depends on its sensitivity to relapse-inducing events that are ineffective in the widely used extinction-based model. It is known that certain drugs can have anti-punishment effects, but these drugs have not been tested in the punishment-based reinstatement procedure. Therefore, the effects of the benzodiazepine, lorazepam, were examined using punishment-based and extinction-based reinstatement procedures. Rats self-administered the opioid, remifentanil (4 microg/kg per infusion). Two punishment groups were trained with response-contingent footshock that suppressed baseline rates of responding to zero. In an extinction group, remifentanil delivery was discontinued, and baseline responding stabilized at a low rate (mean=0.06 responses/min). Lorazepam (0.08-10 mg/kg, IP) was given during test sessions with the shock contingency discontinued for both punishment groups. Remifentanil delivery was maintained during testing in one punishment group but not the other. Lorazepam reinstated self-administration responding in both punishment groups but not in the extinction group. Priming injections of heroin reinstated responding in both the punishment and extinction groups, but combining heroin and lorazepam did not enhance reinstatement. This is the first demonstration that a trigger for relapse may have different effects depending on whether aversive conditioning contributed to the achievement of abstinence. It may be important to consider potential anti-punishment effects of both abused drugs and therapeutic agents in the treatment of individuals with a history of drug abuse.

49 CFR 40.141 - How does the MRO obtain information for the verification decision?

Code of Federal Regulations, 2013 CFR

2013-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the... must conduct a medical interview. You must review the employee's medical history and any other relevant... evaluation by you or another physician. (b) If the employee asserts that the presence of a drug or drug...

49 CFR 40.141 - How does the MRO obtain information for the verification decision?

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the... must conduct a medical interview. You must review the employee's medical history and any other relevant... evaluation by you or another physician. (b) If the employee asserts that the presence of a drug or drug...

49 CFR 40.141 - How does the MRO obtain information for the verification decision?

Code of Federal Regulations, 2014 CFR

2014-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the... must conduct a medical interview. You must review the employee's medical history and any other relevant... evaluation by you or another physician. (b) If the employee asserts that the presence of a drug or drug...

49 CFR 40.141 - How does the MRO obtain information for the verification decision?

Code of Federal Regulations, 2012 CFR

2012-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the... must conduct a medical interview. You must review the employee's medical history and any other relevant... evaluation by you or another physician. (b) If the employee asserts that the presence of a drug or drug...

49 CFR 40.141 - How does the MRO obtain information for the verification decision?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the... must conduct a medical interview. You must review the employee's medical history and any other relevant... evaluation by you or another physician. (b) If the employee asserts that the presence of a drug or drug...

21 CFR 111.15 - What sanitation requirements apply to your physical plant and grounds?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What sanitation requirements apply to your physical plant and grounds? 111.15 Section 111.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... and sanitary conditions; (ii) For use in laboratory testing procedures; (iii) For maintaining or...

Cocaine cues retain silent traces of an excitatory history after conversion into conditioned inhibitors: 'the ghost in the addict'.

PubMed

Weiss, Stanley J; Kearns, David N

2016-04-01

The present experiment investigated the extent to which the A+/AB- conditioned inhibition procedure could counteract an excitatory drug-related conditioning history. In two groups of rats, a light stimulus was established as a signal for the absence of cocaine. For the History group, the light had previously been a discriminative stimulus (S) that occasioned cocaine self-administration and could thus be classified as a cocaine excitor. In comparison, the No-History group first encountered the light during conditioned inhibition training. During conditioned inhibition training, both groups self-administered cocaine during tone as well as during click Ss, whereas drug seeking was eliminated in click-plus-light, wherein cocaine was not available (A+/AB-). Drug seeking was essentially eliminated in both groups. Nevertheless, on a summation test the light reduced cocaine seeking occasioned by the tone S by 95% in the No-History group, but by less than 50% in the History group. This summation test result showed that the effects of a drug-related history persisted even after the light was converted into an effective conditioned inhibitor on the training baseline through the powerful A+/AB- procedure. Future research should seek procedures that produce even stronger conditioned inhibition that eliminates such residual 'silent' drug excitation, the 'ghost in the addict'.

Bioanalytical procedures for monitoring in utero drug exposure

PubMed Central

Gray, Teresa

2009-01-01

Drug use by pregnant women has been extensively associated with adverse mental, physical, and psychological outcomes in their exposed children. This manuscript reviews bioanalytical methods for in utero drug exposure monitoring for common drugs of abuse in urine, hair, oral fluid, blood, sweat, meconium, amniotic fluid, umbilical cord tissue, nails, and vernix caseosa; neonatal matrices are particularly emphasized. Advantages and limitations of testing different maternal and neonatal biological specimens including ease and invasiveness of collection, and detection time frames, sensitivities, and specificities are described, and specific references for available analytical methods included. Future research involves identifying metabolites unique to fetal drug metabolism to improve detection rates of in utero drug exposure and determining relationships between the amount, frequency, and timing of drug exposure and drug concentrations in infant biological fluids and tissues. Accurate bioanalytical procedures are vital to defining the scope of and resolving this important public health problem. PMID:17370066

Development of a dual test procedure for DNA typing and methamphetamine detection using a trace amount of stimulant-containing blood.

PubMed

Irii, Toshiaki; Maebashi, Kyoko; Fukui, Kenji; Sohma, Ryoko; Matsumoto, Sari; Takasu, Shojiro; Iwadate, Kimiharu

2016-05-01

Investigation of drug-related crimes, such as violation of the Stimulant Drug Control Law, requires identifying the used drug (mainly stimulant drugs, methamphetamine hydrochloride) from a drug solution and the DNA type of the drug user from a trace of blood left in the syringe used to inject the drug. In current standard test procedures, DNA typing and methamphetamine detection are performed as independent tests that use two separate portions of a precious sample. The sample can be entirely used up by either analysis. Therefore, we developed a new procedure involving partial lysis of a stimulant-containing blood sample followed by separation of the lysate into a precipitate for DNA typing and a liquid-phase fraction for methamphetamine detection. The method enables these two tests to be run in parallel using a single portion of sample. Samples were prepared by adding methamphetamine hydrochloride water solution to blood. Samples were lysed with Proteinase K in PBS at 56°C for 20min, cooled at -20°C after adding methanol, and then centrifuged at 15,000rpm. Based on the biopolymer-precipitating ability of alcohol, the precipitate was used for DNA typing and the liquid-phase fraction for methamphetamine detection. For DNA typing, the precipitate was dissolved and DNA was extracted, quantified, and subjected to STR analysis using the AmpFℓSTR® Identifiler® Plus PCR Amplification Kit. For methamphetamine detection, the liquid-phase fraction was evaporated with N2 gas after adding 20μL acetic acid and passed through an extraction column; the substances captured in the column were eluted with a solvent, derivatized, and quantitatively detected using gas chromatograph/mass spectrometry. This method was simple and could be completed in approximately 2h. Both DNA typing and methamphetamine detection were possible, which suggests that this method may be valuable for use in criminal investigations. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Comparisons of false negative rates from a trend test alone and from a trend test jointly with a control-high groups pairwise test in the determination of the carcinogenicity of new drugs.

PubMed

Lin, Karl K; Rahman, Mohammad A

2018-05-21

Interest has been expressed in using a joint test procedure that requires that the results of both a trend test and a pairwise comparison test between the control and the high groups be statistically significant simultaneously at the levels of significance recommended in the FDA 2001 draft guidance for industry document for the separate tests in order for the drug effect on the development of an individual tumor type to be considered as statistically significant. Results of our simulation studies show that there is a serious consequence of large inflations of the false negative rate through large decreases of false positive rate in the use of the above joint test procedure in the final interpretation of the carcinogenicity potential of a new drug if the levels of significance recommended for separate tests are used. The inflation can be as high as 204.5% of the false negative rate when the trend test alone is required to test if the effect is statistically significant. To correct the problem, new sets of levels of significance have also been developed for those who want to use the joint test in reviews of carcinogenicity studies.

Chemical dependency and drug testing in the workplace.

PubMed

Osterloh, J D; Becker, C E

1990-05-01

Urine testing for drug use in the workplace is now widespread, with the prevalence of positive drug tests in the work force being 0% to 15%. The prevalence of marijuana use is highest, and this can be reliably tested. Though it is prudent to rid the workplace of drug use, there is little scientific study on the relationship of drug use and workplace outcomes, such as productivity and safety. Probable-cause testing and preemployment testing are the most common applications. Random testing has been less accepted owing to its higher costs, unresolved legal issues, and predictably poor test reliability. Legal issues have focused on the right to policy, discrimination, and the lack of due process. The legal cornerstone of a good program is a policy that is planned and agreed on by both labor and management, which serves both as a contract and as a procedure in which expectations and consequences are known. The National Institute on Drug Abuse is certifying laboratories doing employee drug testing. Testing methods when done correctly are less prone to error than in the past, but screening tests can be defeated by adulterants. Although the incidence of false-positive results is low, such tests are less reliable when the prevalence of drug abuse is also low.

Extinction of Conditioned Responses to Methamphetamine-Associated Stimuli in Healthy Humans.

PubMed

Cavallo, Joel S; Ruiz, Nicholas A; de Wit, Harriet

2016-07-01

Contextual stimuli present during drug experiences become associated with the drug through Pavlovian conditioning and are thought to sustain drug-seeking behavior. Thus, extinction of conditioned responses is an important target for treatment. To date, acquisition and extinction to drug-paired cues have been studied in animal models or drug-dependent individuals, but rarely in non-drug users. We have recently developed a procedure to study acquisition of conditioned responses after single doses of methamphetamine (MA) in healthy volunteers. Here, we examined extinction of these responses and their persistence after conditioning. Healthy adults (18-35 years; N = 20) received two pairings of audio-visual stimuli with MA (20 mg oral) or placebo. Responses to stimuli were assessed before and after conditioning, using three tasks: behavioral preference, attentional bias, and subjective "liking." Subjects exhibited behavioral preference for the drug-paired stimuli at the first post-conditioning test, but this declined rapidly on subsequent extinction tests. They also exhibited a bias to initially look towards the drug-paired stimuli at the first post-test session, but not thereafter. Subjects who experienced more positive subjective drug effects during conditioning exhibited a smaller decline in preference during the extinction phase. Further, longer inter-session intervals during the extinction phase were associated with less extinction of the behavioral preference measure. Conditioned responses after two pairings with MA extinguish quickly, and are influenced by both subjective drug effects and the extinction interval. Characterizing and refining this conditioning procedure will aid in understanding the acquisition and extinction processes of drug-related conditioned responses in humans.

Extinction of Conditioned Responses to Methamphetamine-Associated Stimuli in Healthy Humans

PubMed Central

Cavallo, Joel S.; Ruiz, Nicholas A.; de Wit, Harriet

2016-01-01

Rationale Contextual stimuli present during drug experiences become associated with the drug through Pavlovian conditioning, and are thought to sustain drug-seeking behavior. Thus, extinction of conditioned responses is an important target for treatment. To date, acquisition and extinction to drug-paired cues have been studied in animal models or drug-dependent individuals, but rarely in non drug-users. Objective We have recently developed a procedure to study acquisition of conditioned responses after single doses of methamphetamine (MA) in healthy volunteers. Here we examined extinction of these responses and their persistence after conditioning. Methods Healthy adults (18–35 yrs; N=20) received two pairings of audio-visual stimuli with MA (20 mg oral) or placebo. Responses to stimuli were assessed before and after conditioning, using three tasks: behavioral preference, attentional bias, and subjective ‘liking.’ Results Subjects exhibited behavioral preference for the drug-paired stimuli at the first post-conditioning test, but this declined rapidly on subsequent extinction tests. They also exhibited a bias to initially look towards the drug-paired stimuli at the first post-test session, but not thereafter. Subjects who experienced more positive subjective drug effects during conditioning exhibited a smaller decline in preference during the extinction phase. Further, longer inter-session intervals during the extinction phase were associated with less extinction of the behavioral preference measure. Conclusions Conditioned responses after two pairings with MA extinguish quickly, and are influenced by both subjective drug effects and the extinction interval. Characterizing and refining this conditioning procedure will aid in understanding the acquisition and extinction processes of drug-related conditioned responses in humans. PMID:27113223

[Sensitization to chymopapain in patients treated with chemonucleolysis].

PubMed

García-Ortega, P; Ramírez Ferreiras, W; Sancho, A; Urías, S; Cisteró, A

1991-03-23

Chemonucleolysis (intradisk administration of chymopapain) is a procedure to treat intervertebral disk hernia. Recently, its use has been questioned due to the development of anaphylactic reactions in patients sensitized to chymopapain. The prevalence of sensitization to chymopapain has been evaluated before and after chemonucleolysis, and the possibility to establish risk groups through the allergy history has been assessed. 104 consecutive patients who were candidates to chemonucleolysis were evaluated with an allergy questionnaire, cutaneous tests to aeroallergens and to chymopapain, and chymopapain-specific IgE. The two latter tests were repeated one month after chemonucleolysis. Only 2 patients (1.9%) showed evidence of chymopapain sensitization before the procedure. Sixteen patients (16%) were sensitized after chemonucleolysis. None of the possible risk factors evaluated in the allergy questionnaire (atopy, drug allergy, papaya occupational exposure or use of additives, cosmetics or drugs containing papaine) were significantly related with the risk of sensitization to chymopapain. The prevalence of chymopapain sensitization in the study group was low. The allergy questionnaire (atopy, drug allergy, use of papaya, occupational history did not identify sensitized patients. Cutaneous tests and specific IgE are the best method to detect chymopapain sensitization. The remarkable rate of sensitization after chemonucleolysis may partially limit the usefulness of the procedure.

Abuse liability assessment in preclinical drug development: predictivity of a translational approach for abuse liability testing using methylphenidate in four standardized preclinical study models.

PubMed

Teuns, Greet B A; Geys, Helena M; Geuens, Sonja M A; Stinissen, Piet; Meert, Theo F

2014-01-01

Preclinical abuse liability assessment of novel clinical CNS-active candidates involves several tests, addressing different aspects characteristic for abuse potential, which are considered predictive for substance abuse of these candidates, thus ensuring an appropriate translational approach. To demonstrate how such a strategy could work, a known drug of abuse, methylphenidate was evaluated in a full rodent test battery, comprising four test models, and in accordance with the requirements of the FDA, ICH and EMA guidelines. Methylphenidate was tested orally at 2.5, 5 or 10mg/kg for its physical dependence potential in a repeated dose non-precipitated withdrawal test, for its drug profiling in a drug discrimination learning procedure (single escalating doses), and for its reinforcing properties in a conditioned place preference test (alternate dosing days) and an intravenous self-administration procedure (0.05 to 1mg/kg/IV infusion during 5 daily 1-h test sessions). The stimulant d-amphetamine served as positive control and was administered subcutaneously at 0.8mg/kg in the first three test models. In the intravenous self-administration procedure rats were habituated to intravenously self-administer d-amphetamine at 0.06mg/kg/IV infusion prior to methylphenidate substitution. Cessation of subchronic dosing up to 10mg/kg methylphenidate led to sustained or even exacerbated effects on locomotion and behavior, body temperature, body weight, food consumption, and alteration of the diurnal rhythm during withdrawal. Clear generalization to d-amphetamine was obtained in the drug discrimination test at 5 and 10mg/kg. Distinct reinforcing properties were present in the conditioned place preference test at 10mg/kg and in the intravenous self-administration study from 0.05mg/kg/IV infusion onwards. The maximum plasma exposure after oral administration of methylphenidate over the dose ranges tested in the present rat studies covered at least 1.9-fold to 18.9-fold the recommended human therapeutic exposure of 10ng/ml, a plasma level that is considered representative of the human efficacious methylphenidate dose. The ratio Cmax Hu/rat calculated from the intravenous self-administration data ranged from 14.9 to 576.5. Consequently the regulatory requirements, stating that preclinical drug abuse liability studies should include high doses that produce plasma levels that are multiples of the therapeutic dose were fulfilled (FDA, EMA, ICH). The presented preclinical models, implemented within a drug development environment, were considered highly predictive to assess the abuse potential of methylphenidate, and in accordance with the regulatory requirements of drug licensing authorities in terms of appropriate methods, dose selection and subsequent plasma exposure. Copyright © 2014 Elsevier Inc. All rights reserved.

Consequences of Decontamination Procedures in Forensic Hair Analysis Using Metal-Assisted Secondary Ion Mass Spectrometry Analysis.

PubMed

Cuypers, Eva; Flinders, Bryn; Boone, Carolien M; Bosman, Ingrid J; Lusthof, Klaas J; Van Asten, Arian C; Tytgat, Jan; Heeren, Ron M A

2016-03-15

Today, hair testing is considered to be the standard method for the detection of chronic drug abuse. Nevertheless, the differentiation between systemic exposure and external contamination remains a major challenge in the forensic interpretation of hair analysis. Nowadays, it is still impossible to directly show the difference between external contamination and use-related incorporation. Although the effects of washing procedures on the distribution of (incorporated) drugs in hair remain unknown, these decontamination procedures prior to hair analysis are considered to be indispensable in order to exclude external contamination. However, insights into the effect of decontamination protocols on levels and distribution of drugs incorporated in hair are essential to draw the correct forensic conclusions from hair analysis; we studied the consequences of these procedures on the spatial distribution of cocaine in hair using imaging mass spectrometry. Additionally, using metal-assisted secondary ion mass spectrometry, we are the first to directly show the difference between cocaine-contaminated and user hair without any prior washing procedure.

Breast Cyst Aspiration

MedlinePlus

... TestingRead Article >>Plasma Viral Load TestingInsulin TherapyRead Article >>Insulin Therapy Visit our interactive symptom checker Visit our interactive symptom checker Get Started Related ArticlesPlasma Viral Load TestingRead ... TherapyRead Article >>Drugs, Procedures & DevicesInsulin TherapyThe goal of ...

European guidelines for workplace drug testing in urine.

PubMed

Taskinen, Sanna; Beck, Olof; Bosch, Tessa; Brcak, Michaela; Carmichael, Duncan; Fucci, Nadia; George, Claire; Piper, Mark; Salomone, Alberto; Schielen, Wim; Steinmeyer, Stefan; Weinmann, Wolfgang

2017-06-01

These European Guidelines for Workplace Drug Testing in Urine have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). The first version of these urine guidelines was published in 2002. Since then, the guidelines have been followed by many laboratories in different European countries and their role has been essential particularly in countries lacking legislation for workplace drug testing. In 2014, the EWDTS started a guidelines updating project and published a new version of the urine guidelines in 2015. Here we represent this updated version of the urine guidelines. The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing should use these guidelines as a template for accreditation. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Procedural and declarative memory performance, and the memory consolidation function of sleep, in recent and abstinent Ecstasy/MDMA users

PubMed Central

Blagrove, Mark; Seddon, Jennifer; George, Sophie; Parrott, Andrew C.; Stickgold, Robert; Walker, Matthew; Jones, Katy; Morgan, Michael J.

2013-01-01

This study assessed the effects of ecstasy/MDMA on declarative memory (Rivermead Behavioral Memory task - RBMT), on procedural learning (Finger Tapping Task - FTT), and on the memory consolidation function of sleep for these two tasks. Testing occurred in 2 afternoon testing sessions, 24 hours apart so that a full period of sleep was allowed between them. Groups were: Non-drug taking Controls (n=24); Recent Ecstasy/MDMA users, who had taken ecstasy and/or MDMA 2–3 days before the first testing session (n=25), and Abstinent Ecstasy/MDMA users, who had not taken ecstasy/MDMA for at least 8 days before the first session (n=17). The recent ecstasy/MDMA users performed significantly worse than controls on the RBMT (mean recall 76.1% of control group recall), but did not differ from controls on FTT performance. Correspondingly there was a significant regression between the continuous variable of recency of ecstasy/MDMA use and RBMT performance. However, there was an interaction between ecstasy/MDMA use and subsequent other drug use. Controls had similar RBMT scores to recent ecstasy/MDMA users who did not take other drugs 48 – 24 hours before testing, but scored significantly better than recent ecstasy/MDMA users who took various other drugs (mainly cannabis) 48 – 24 hours before testing. For both tasks the control, recent ecstasy/MDMA and abstinent ecstasy/MDMA users did not differ in their change of performance across 24 hours; there was thus no evidence that ecstasy/MDMA impairs the memory consolidation function of sleep for either declarative or procedural memory. For participants in the two ecstasy/MDMA groups greater lifetime consumption of ecstasy tablets was associated with significantly more deficits in procedural memory. Furthermore, greater lifetime consumption of ecstasy tablets and of cocaine, were also associated with significantly more deficits in declarative memory. PMID:20615932

Proceedings of the drug testing laboratory managers symposium, 28 January--1 February 1974. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Noe, E.R.; Romanchick, W.A.; Ainsworth, C.A. III

1975-06-01

This report deals with broad concepts of managing mass screening programs for drugs of abuse; e.g., morphine, barbiturate, amphetamine, cocaine, and methaqualone. The interactions of the screening process and of the rehabilitation program were covered. Psychotherapy and group therapy are both utilized in rehabilitation programs. The semiautomated radioimmunoassay (RIA) screening procedures are both sensitive and specific at nanogram quantities. Future evaluations of a wafer disk transferral system and of a latex test for morphine are presented. The unique quality control system employed by military drug abuse testing laboratories is discussed. (Author) (GRA)

75 FR 79320 - Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... is calculated from tumor data of the cancer bioassays using a statistical extrapolation procedure... carcinogenic concern currently set forth in Sec. 500.84 utilizes a statistical extrapolation procedure that... procedures did not rely on a statistical extrapolation of the data to a 1 in 1 million risk of cancer to test...

Determination of the external contamination and cross-contamination by cytotoxic drugs on the surfaces of vials available on the Swiss market.

PubMed

Fleury-Souverain, Sandrine; Nussbaumer, Susanne; Mattiuzzo, Marc; Bonnabry, Pascal

2014-04-01

The external contamination and cross-contamination by cytotoxic drugs on the surface (outside and septum) of 133 vials from various manufacturers and available on the Swiss market were evaluated. All of the tested vials contained one of the following active ingredients: cyclophosphamide, cytarabine, doxorubicin, epirubicin, etoposide phosphate, gemcitabine, ifosfamide, irinotecan, methotrexate or vincristine. The validated wiping liquid chromatography-mass spectrometry method used in this study allowed for the simultaneous determination of these 10 cytotoxic drugs in less than 30 min. External contamination by cytotoxic drugs was detected on 63% of tested vials (outside and septum). The highest contamination level was observed on etoposide phosphate vials with 1896.66 ng of active ingredient on the outside of the vial. Approximately 20% of the contaminated vials had greater than 10 ng of cytotoxic drugs. Chemical contamination on the septum was detected on 38% of the vials. No contamination or very low levels of cytotoxic drugs, less than 1 ng per vial, were detected on the vials protected by plastic shrink-wrap. Traces of cytotoxic drugs different from the active ingredient were detected on 35% of the tested vials. Handling cytotoxic vials with gloves and having a procedure for the decontamination of vials are of the utmost importance for reducing exposure to cytotoxic drugs. Moreover, manufacturers must improve their procedures to provide products free from any contamination.

Development of potential candidate reference materials for drugs in bottom sediment, cod and herring tissues.

PubMed

Baranowska, Irena; Buszewski, Bogusław; Namieśnik, Jacek; Konieczka, Piotr; Magiera, Sylwia; Polkowska-Motrenko, Halina; Kościelniak, Paweł; Gadzała-Kopciuch, Renata; Woźniakiewicz, Aneta; Samczyński, Zbigniew; Kochańska, Kinga; Rutkowska, Małgorzata

2017-02-01

Regular use of a reference material and participation in a proficiency testing program can improve the reliability of analytical data. This paper presents the preparation of candidate reference materials for the drugs metoprolol, propranolol, carbamazepine, naproxen, and acenocoumarol in freshwater bottom sediment and cod and herring tissues. These reference materials are not available commercially. Drugs (between 7 ng/g and 32 ng/g) were added to the samples, and the spiked samples were freeze-dried, pulverized, sieved, homogenized, bottled, and sterilized by γ-irradiation to prepare the candidate materials. Procedures for extraction and liquid chromatography coupled with tandem mass spectrometry were developed to determine the drugs of interest in the studied material. Each target drug was quantified using two analytical procedures, and the results obtained from these two procedures were in good agreement with each other. Stability and homogeneity assessments were performed, and the relative uncertainties due to instability (for an expiration date of 12 months) and inhomogeneity were 10-25% and 4.0-6.8%, respectively. These procedures will be useful in the future production of reference materials. Copyright © 2016 Elsevier Ltd. All rights reserved.

49 CFR 40.162 - What must MROs do with multiple verified results for the same testing event?

Code of Federal Regulations, 2013 CFR

2013-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers... verified the specimen as being positive for marijuana and cocaine and as being a refusal to test because...

49 CFR 40.162 - What must MROs do with multiple verified results for the same testing event?

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers... verified the specimen as being positive for marijuana and cocaine and as being a refusal to test because...

49 CFR 40.162 - What must MROs do with multiple verified results for the same testing event?

Code of Federal Regulations, 2010 CFR

2010-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers... verified the specimen as being positive for marijuana and cocaine and as being a refusal to test because...

49 CFR 40.162 - What must MROs do with multiple verified results for the same testing event?

Code of Federal Regulations, 2011 CFR

2011-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers... verified the specimen as being positive for marijuana and cocaine and as being a refusal to test because...

49 CFR 40.162 - What must MROs do with multiple verified results for the same testing event?

Code of Federal Regulations, 2014 CFR

2014-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers... verified the specimen as being positive for marijuana and cocaine and as being a refusal to test because...

Joint and Soft Tissue Injections

MedlinePlus

... TestingRead Article >>Plasma Viral Load TestingInsulin TherapyRead Article >>Insulin Therapy Visit our interactive symptom checker Visit our interactive symptom checker Get Started Related ArticlesPlasma Viral Load TestingRead ... TherapyRead Article >>Drugs, Procedures & DevicesInsulin TherapyThe goal of ...

Multidimensional Screening as a Pharmacology Laboratory Experience.

ERIC Educational Resources Information Center

Malone, Marvin H.; And Others

1979-01-01

A multidimensional pharmacodynamic screening experiment that addresses drug interaction is included in the pharmacology-toxicology laboratory experience of pharmacy students at the University of the Pacific. The student handout with directions for the procedure is reproduced, drug compounds tested are listed, and laboratory evaluation results are…

Application of drug testing using exhaled breath for compliance monitoring of drug addicts in treatment.

PubMed

Carlsson, Sten; Olsson, Robert; Lindkvist, Irene; Beck, Olof

2015-04-01

Exhaled breath has recently been identified as a possible matrix for drug testing. This study explored the potential of this new method for compliance monitoring of patients being treated for dependence disorders. Outpatients in treatment programs were recruited for this study. Urine was collected as part of clinical routine and a breath sample was collected in parallel together with a questionnaire about their views of the testing procedure. Urine was analyzed for amphetamines, benzodiazepines, cannabis, cocaine, buprenorphine, methadone and opiates using CEDIA immunochemical screening and mass spectrometry confirmation. The exhaled breath was collected using the SensAbues device and analyzed by mass spectrometry for amphetamine, methamphetamine, diazepam, oxazepam, tetrahydrocannabinol, cocaine, benzoylecgonine, buprenorphine, methadone, morphine, codeine and 6-acetylmorphine. A total of 122 cases with parallel urine and breath samples were collected; 34 of these were negative both in urine and breath. Out of 88 cases with positive urine samples 51 (58%) were also positive in breath. Among the patients on methadone treatment, all were positive for methadone in urine and 83% were positive in breath. Among patients in treatment with buprenorphine, 92% were positive in urine and among those 80% were also positive in breath. The questionnaire response documented that in general, patients accepted drug testing well and that the breath sampling procedure was preferred. Compliance testing for the intake of prescribed and unprescribed drugs among patients in treatment for dependence disorders using the exhaled breath sampling technique is a viable method and deserves future attention.

Assessment of light stability of drugs in blood and plasma.

PubMed

de Vries, Ronald; Diels, Luc; Dillen, Lieve; Sips, Luc; Van Roosbroek, Dirk; Verhaeghe, Tom; Timmerman, Philip

2016-10-01

A procedure was developed for the assessment of photochemical stability of drugs in blood and plasma under standardized conditions. The procedure avoids a variable outcome of photochemical stability experiments and tests relevant worst case conditions so that unnecessary light protection is avoided. Results/methodology: Blood and plasma were spiked with a mixture of drugs and incubated in a Suntest CPS(+), in the laboratory on the bench and near the window on a sunny summer day. The results were compared. No protection from light, limited protection from light and full protection from light are advised for drugs that are stable in plasma in the Suntest CPS(+) at 250 W/m(2) for at least 30 min, for 5-30 min and for <5 min, respectively.

49 CFR 40.167 - How are MRO reports of drug results transmitted to the employer?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false How are MRO reports of drug results transmitted to the employer? 40.167 Section 40.167 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.167 How are MRO reports...

Evaluation of the Discover Drug Education Curriculum for Grades K-4.

ERIC Educational Resources Information Center

Adams, Ronald D.; Butler, Joan M.

A major purpose of this study was to establish and test a procedure for evaluating drug education curricula that allows for a more objective view of the effectiveness of drug education materials and the instructional delivery system. A major focus of the study was to determine the extent to which the Discover Curriculum affected student outcomes.…

49 CFR 40.211 - Who conducts DOT alcohol tests?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false Who conducts DOT alcohol tests? 40.211 Section 40.211 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Alcohol Testing Personnel § 40.211 Who conducts DOT alcohol tests? (a) Screening test technicians (STTs) and breat...

49 CFR 40.1 - Who does this regulation cover?

Code of Federal Regulations, 2013 CFR

2013-10-01

... parties who conduct drug and alcohol tests required by Department of Transportation (DOT) agency regulations how to conduct these tests and what procedures to use. (b) This part concerns the activities of... post-accident testing program (see 49 CFR 219.200). ...

The role of human drug self-administration procedures in the development of medications

PubMed Central

Comer, SD; Ashworth, JB; Foltin, RW; Johanson, CE; Zacny, JP; Walsh, SL

2008-01-01

The purpose of this review is to illustrate the utility and value of employing human self-administration procedures in medication development, including abuse liability assessments of novel medications and evaluation of potential pharmacotherapies for substance use disorders. Traditionally, human abuse liability testing has relied primarily on subjective reports describing drug action by use of questionnaires; similarly, drug interactions between putative treatment agents and the drugs of abuse have relied on these measures. Subjective reports are highly valued because they provide qualitative and quantitative information about the characteristics of central and peripheral pharmacodynamic effects as well as safety and tolerability. However, self-administration procedures directly examine the behavior of interest – that is, drug taking. The present paper 1) reviews the most commonly used human self-administration procedures, 2) discusses the concordance of subjective reports and self-administration within the context of medications development for substance use disorders, focusing primarily on illustrative examples from development efforts with opioid and cocaine dependence, and 3) explores the utility of applying self-administration procedures to assess the abuse liability of novel compounds, including “abuse deterrent” formulations (ADFs). The review will focus on opioid and cocaine dependence because a rich database from both clinical laboratory and clinical trial research exists for these two drug classes. The data reviewed suggest that drug-induced changes in self-administration and subjective effects are not always concordant. Therefore, assessment of self-administration in combination with subjective effects provides a more comprehensive picture that may have improved predictive validity for translating to the clinical setting. PMID:18436394

The motivation to self-administer is increased after a history of spiking brain levels of cocaine.

PubMed

Zimmer, Benjamin A; Oleson, Erik B; Roberts, David Cs

2012-07-01

Recent attempts to model the addiction process in rodents have focused on cocaine self-administration procedures that provide extended daily access. Such procedures produce a characteristic loading phase during which blood levels rapidly rise and then are maintained within an elevated range for the duration of the session. The present experiments tested the hypothesis that multiple fast-rising spikes in cocaine levels contribute to the addiction process more robustly than constant, maintained drug levels. Here, we compared the effects of various cocaine self-administration procedures that produced very different patterns of drug intake and drug dynamics on Pmax, a behavioral economic measure of the motivation to self-administer drug. Two groups received intermittent access (IntA) to cocaine during daily 6-h sessions. Access was limited to twelve 5-min trials that alternated with 25-min timeout periods, using either a hold-down procedure or a fixed ratio 1 (FR1). Cocaine levels could not be maintained with this procedure; instead the animals experienced 12 fast-rising spikes in cocaine levels each day. The IntA groups were compared with groups given 6-h FR1 long access and 2-h short access sessions and two other control groups. Here, we report that cocaine self-administration procedures resulting in repeatedly spiking drug levels produce more robust increases in Pmax than procedures resulting in maintained high levels of cocaine. These results suggest that rapid spiking of brain-cocaine levels is sufficient to increase the motivation to self-administer cocaine.

Determination of different recreational drugs in sweat by headspace solid-phase microextraction gas chromatography mass spectrometry (HS-SPME GC/MS): Application to drugged drivers.

PubMed

Gentili, Stefano; Mortali, Claudia; Mastrobattista, Luisa; Berretta, Paolo; Zaami, Simona

2016-09-10

A procedure based on headspace solid-phase microextraction (HS-SPME) coupled with gas chromatography/mass spectrometry (GC/MS) has been developed for the determination of most commonly used drugs of abuse in sweat of drivers stopped during roadside controls. DrugWipe 5A sweat screening device was used to collect sweat by a specific pad rubbed gently over forehead skin surface. The procedure involved an acid hydrolysis, a HS-SPME extraction for drugs of abuse but Δ(9)-tetrahydrocannabinol, which was directly extracted in alkaline medium HS-SPME conditions, a GC separation of analytes by a capillary column and MS detection by electron impact ionisation. The method was linear from the limit of quantification (LOQ) to 50ng drug per pad (r(2)≥0.99), with an intra- and inter-assay precision and accuracy always less than 15% and an analytical recovery between 95.1% and 102.8%, depending on the considered analyte. Using the validated method, sweat from 60 apparently intoxicated drivers were found positive to one or more drugs of abuse, showing sweat patches testing as a viable economic and simple alternative to conventional (blood and/or urine) and non conventional (oral fluid) testing of drugs of abuse in drugged drivers. Copyright © 2016 Elsevier B.V. All rights reserved.

21 CFR 58.107 - Test and control article handling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Test and control article handling. 58.107 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.107 Test and control article handling. Procedures shall be established for a system for the handling of the test and...

21 CFR 58.107 - Test and control article handling.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Test and control article handling. 58.107 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.107 Test and control article handling. Procedures shall be established for a system for the handling of the test and...

21 CFR 58.107 - Test and control article handling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Test and control article handling. 58.107 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.107 Test and control article handling. Procedures shall be established for a system for the handling of the test and...

21 CFR 58.107 - Test and control article handling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Test and control article handling. 58.107 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.107 Test and control article handling. Procedures shall be established for a system for the handling of the test and...

Effectiveness of adverse effects search filters: drugs versus medical devices.

PubMed

Farrah, Kelly; Mierzwinski-Urban, Monika; Cimon, Karen

2016-07-01

The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%-87%) than for drugs (88%-93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%-81%) than in MEDLINE (67%-87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.

21 CFR 58.90 - Animal care.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Animal care. 58.90 Section 58.90 Food and Drugs... FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.90 Animal care. (a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals. (b) All...

21 CFR 58.90 - Animal care.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Animal care. 58.90 Section 58.90 Food and Drugs... FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.90 Animal care. (a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals. (b) All...

21 CFR 58.90 - Animal care.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Animal care. 58.90 Section 58.90 Food and Drugs... FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.90 Animal care. (a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals. (b) All...

21 CFR 58.90 - Animal care.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Animal care. 58.90 Section 58.90 Food and Drugs... FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.90 Animal care. (a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals. (b) All...

21 CFR 58.90 - Animal care.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Animal care. 58.90 Section 58.90 Food and Drugs... FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.90 Animal care. (a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals. (b) All...

Drugs in Sport

ERIC Educational Resources Information Center

Mottram, David

2012-01-01

Drugs may be used by athletes for a number of reasons, including performance enhancement. The role of the World Anti-Doping Agency (WADA) is vital to ensure a winning performance has been achieved by fair means. Substances and methods that are included on the WADA Prohibited List are described. The procedures for testing banned substances are…

46 CFR 4.06-50 - Specimen analysis and follow-up procedures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... MARINE CASUALTIES AND INVESTIGATIONS Mandatory Chemical Testing Following Serious Marine Incidents... sent to the Medical Review Officer meeting the requirements of 49 CFR 40.121, as designated by the... of a dangerous drug or drug metabolite, the Medical Review Officer shall review the report as...

46 CFR 4.06-50 - Specimen analysis and follow-up procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... MARINE CASUALTIES AND INVESTIGATIONS Mandatory Chemical Testing Following Serious Marine Incidents... sent to the Medical Review Officer meeting the requirements of 49 CFR 40.121, as designated by the... of a dangerous drug or drug metabolite, the Medical Review Officer shall review the report as...

46 CFR 4.06-50 - Specimen analysis and follow-up procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... MARINE CASUALTIES AND INVESTIGATIONS Mandatory Chemical Testing Following Serious Marine Incidents... sent to the Medical Review Officer meeting the requirements of 49 CFR 40.121, as designated by the... of a dangerous drug or drug metabolite, the Medical Review Officer shall review the report as...

49 CFR 40.33 - What training requirements must a collector meet?

Code of Federal Regulations, 2012 CFR

2012-10-01

... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Collection Personnel § 40.33 What training... about this part, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency... changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available...

49 CFR 40.33 - What training requirements must a collector meet?

Code of Federal Regulations, 2013 CFR

2013-10-01

... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Collection Personnel § 40.33 What training... about this part, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency... changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available...

49 CFR 40.33 - What training requirements must a collector meet?

Code of Federal Regulations, 2011 CFR

2011-10-01

... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Collection Personnel § 40.33 What training... about this part, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency... changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available...

49 CFR 40.33 - What training requirements must a collector meet?

Code of Federal Regulations, 2010 CFR

2010-10-01

... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Collection Personnel § 40.33 What training... about this part, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency... changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available...

49 CFR 40.33 - What training requirements must a collector meet?

Code of Federal Regulations, 2014 CFR

2014-10-01

... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Collection Personnel § 40.33 What training... about this part, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency... changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available...

49 CFR 40.241 - What are the first steps in any alcohol screening test?

Code of Federal Regulations, 2011 CFR

2011-10-01

... facility who is required to have a post-accident test), do not delay this treatment to conduct a test. (c... test? 40.241 Section 40.241 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Alcohol Screening Tests § 40.241 What are the first...

49 CFR 40.241 - What are the first steps in any alcohol screening test?

Code of Federal Regulations, 2013 CFR

2013-10-01

... facility who is required to have a post-accident test), do not delay this treatment to conduct a test. (c... test? 40.241 Section 40.241 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Alcohol Screening Tests § 40.241 What are the first...

49 CFR 40.241 - What are the first steps in any alcohol screening test?

Code of Federal Regulations, 2014 CFR

2014-10-01

... facility who is required to have a post-accident test), do not delay this treatment to conduct a test. (c... test? 40.241 Section 40.241 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Alcohol Screening Tests § 40.241 What are the first...

49 CFR 40.241 - What are the first steps in any alcohol screening test?

Code of Federal Regulations, 2012 CFR

2012-10-01

... facility who is required to have a post-accident test), do not delay this treatment to conduct a test. (c... test? 40.241 Section 40.241 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Alcohol Screening Tests § 40.241 What are the first...

49 CFR 40.241 - What are the first steps in any alcohol screening test?

Code of Federal Regulations, 2010 CFR

2010-10-01

... facility who is required to have a post-accident test), do not delay this treatment to conduct a test. (c... test? 40.241 Section 40.241 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Alcohol Screening Tests § 40.241 What are the first...

49 CFR 40.221 - Where does an alcohol test take place?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false Where does an alcohol test take place? 40.221 Section 40.221 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Testing Sites, Forms, Equipment and Supplies Used in Alcohol Testing § 40.221 Where does an alcohol test...

49 CFR 40.409 - What does the issuance of a PIE mean to transportation employers?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public Interest Exclusions § 40.409... Department issues a PIE concerning Service Agent N on September 1. All tests conducted using N's services...

49 CFR Appendix G to Part 40 - Alcohol Testing Form

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false Alcohol Testing Form G Appendix G to Part 40 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. G Appendix G to Part 40—Alcohol Testing Form The following form is the...

49 CFR Appendix G to Part 40 - Alcohol Testing Form

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false Alcohol Testing Form G Appendix G to Part 40 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. G Appendix G to Part 40—Alcohol Testing Form The following form is the...

49 CFR Appendix G to Part 40 - Alcohol Testing Form

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false Alcohol Testing Form G Appendix G to Part 40 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. G Appendix G to Part 40—Alcohol Testing Form The following form is the...

49 CFR Appendix G to Part 40 - Alcohol Testing Form

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false Alcohol Testing Form G Appendix G to Part 40 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. G Appendix G to Part 40—Alcohol Testing Form The following form is the...

49 CFR Appendix G to Part 40 - Alcohol Testing Form

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Alcohol Testing Form G Appendix G to Part 40 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. G Appendix G to Part 40—Alcohol Testing Form The following form is the...

Rapid screening procedure based on headspace solid-phase microextraction and gas chromatography-mass spectrometry for the detection of many recreational drugs in hair.

PubMed

Gentili, Stefano; Cornetta, Maria; Macchia, Teodora

2004-03-05

An increasing number of synthetic drugs are appearing on the illicit market and on the scene of drug use by youngsters. Official figures are underestimated. In addition, immunochemical tests are blind to many of these drugs and appropriate analytical procedures for routine clinical and epidemiological purposes are lacking. Therefore, the perceived increasing abuse of recreational drugs has not been proved yet. In a previous paper, we proposed a procedure for the preliminary screening of several recreational substances in hair and other biological matrices. Unfortunately, this procedure cannot apply to cocaine. Consequently, we performed a new headspace solid-phase microextraction and gas chromatography-mass spectrometry (HS-SPME-GC-MS) procedure for the simultaneous detection of cocaine, amphetamine (A), methamphetamine (MA), methylen-dioxyamphetamine (MDA), methylen-dioxymethamphetamine (MDMA), methylen-dioxyethamphetamine (MDE), N-methyl-1-(1,3-benzodioxol-5-yl)-2-butanamine (MBDB), ketamine, and methadone in human hair. Hair was washed with water and acetone in an ultrasonic bath. A short acid extraction with 1M hydrochloric acid was needed; the fiber was exposed to a 5 min absorption at 90 degrees C and thermal desorption was performed at 250 degrees C for 3 min. The procedure was simple, rapid, required small quantities of sample and no derivatization. Good linearity was obtained over the 0.1-20.0 ng/mg range for the target compounds. Sensitivity was good enough: limits of detection (LOD) were 0.7 ng/mg of hair for the majority of substances. The intra-day precision ranged between 7 and 20%. This paper deals with the analytical performance of this procedure and its preliminary application to hair samples obtained on a voluntary basis from 183 young people (138 males and 45 females) in the Rome area.

75 FR 49850 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

.... Some commenters urged the Department to choose a different approach from the HHS regarding the drugs....S.C. 45100, et seq. (Omnibus Act), as the definitive authority for our reliance on the HHS Mandatory... different from those of Federal agencies.'' (53 FR 47002) Thus, the Department began to lay the foundation...

Biosensor technology for the detection of illegal drugs II: antibody development and detection techniques

NASA Astrophysics Data System (ADS)

Hilpert, Reinhold; Bauer, Christian; Binder, Florian; Grol, Michael; Hallermayer, Klaus; Josel, Hans-Peter; Klein, Christian; Maier, Josef; Makower, Alexander; Oberpriller, Helmut; Ritter, Josef

1994-10-01

In a joint project of Deutsche Aerospace, Boehringer Mannheim and the University of Potsdam portable devices for the detection of illegal drugs, based on biosensor technology, are being developed. The concept enrichment of the drug from the gas phase and detection by immunological means. This publication covers the development of specific antibodies and various detection procedures. Antibodies with a high affinity for cocaine have been developed with the aid of specially synthesized immunogens. A competitive detection procedure with biosensors based on optical grating couplers and applying particulate labels has been established, showing a lower detection limit of 10-10 mol/l for cocaine. Additionally, a combination of a displacement-immunoreactor and an enzymatically amplified electrode was investigated, which at present still suffers from insufficient sensitivity of the immunoreactor. An alternative, fleece-matrix based test procedure, where enrichment and detection steps are integrated in a single unit, is promising in terms of simplicity and sensitivity. A simple swab-test for the detection of cocaine at surfaces has been developed, which has a lower detection limit of about 10 ng and which can be performed within one minute.

Revisiting susceptibility testing in MDR-TB by a standardized quantitative phenotypic assessment in a European multicentre study.

PubMed

Cambau, E; Viveiros, M; Machado, D; Raskine, L; Ritter, C; Tortoli, E; Matthys, V; Hoffner, S; Richter, E; Perez Del Molino, M L; Cirillo, D M; van Soolingen, D; Böttger, E C

2015-03-01

Treatment outcome of MDR-TB is critically dependent on the proper use of second-line drugs as per the result of in vitro drug susceptibility testing (DST). We aimed to establish a standardized DST procedure based on quantitative determination of drug resistance and compared the results with those of genotypes associated with drug resistance. The protocol, based on MGIT 960 and the TB eXiST software, was evaluated in nine European reference laboratories. Resistance detection at a screening drug concentration was followed by determination of resistance levels and estimation of the resistance proportion. Mutations in 14 gene regions were investigated using established techniques. A total of 139 Mycobacterium tuberculosis isolates from patients with MDR-TB and resistance beyond MDR-TB were tested for 13 antituberculous drugs: isoniazid, rifampicin, rifabutin, ethambutol, pyrazinamide, streptomycin, para-aminosalicylic acid, ethionamide, amikacin, capreomycin, ofloxacin, moxifloxacin and linezolid. Concordance between phenotypic and genotypic resistance was >80%, except for ethambutol. Time to results was short (median 10 days). High-level resistance, which precludes the therapeutic use of an antituberculous drug, was observed in 49% of the isolates. The finding of a low or intermediate resistance level in 16% and 35% of the isolates, respectively, may help in designing an efficient personalized regimen for the treatment of MDR-TB patients. The automated DST procedure permits accurate and rapid quantitative resistance profiling of first- and second-line antituberculous drugs. Prospective validation is warranted to determine the impact on patient care. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Patch testing in non-immediate cutaneous adverse drug reactions: value of extemporaneous patch tests.

PubMed

Assier, Haudrey; Valeyrie-Allanore, Laurence; Gener, Gwendeline; Verlinde Carvalh, Muriel; Chosidow, Olivier; Wolkenstein, Pierre

2017-11-01

Patch testing following a standardized protocol is reliable for identifying the culprit drug in cutaneous adverse drug reactions (CADRs). However, these patch tests (PTs) require pharmaceutical material and staff, which are not always easily available. To evaluate an extemporaneous PT method in CADRs. We retrospectively analysed data for all patients referred to our department between March 2009 and June 2013 for patch testing after a non-immediate CADR. The patients who supplied their own suspected drugs were tested both with extemporaneous PTs and with conventional PTs. Extemporaneous PTs involved a nurse crushing and diluting the drug in pet. in a ratio of approximately one-third to two-thirds. Standardized PTs were performed according to guidelines, with commercial drugs diluted to 30% or with active ingredients diluted to 10%. We analysed the data for the two PT methods in terms of the number of positive test reactions, drugs tested, and type of CADR for patients in whom the two PT methods were used. In total, 75 of 156 patients underwent the two PT procedures, including 91 double tests. Overall, 21 tests gave positive reactions with the two methods, and 69 other tests gave negative results with the two methods. Our series yielded results similar to those of published series concerning the types of CADR and the drugs responsible. Our results suggest that, for CADRs, if a patient supplies a suspected drug but if the pharmaceutical material and staff are not available for conventional PTs, extemporaneous PTs performed by the nurse with the commercial drug used by the patient can be useful and reliable. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Hypothesis testing for the validation of the kinetic spectrophotometric methods for the determination of lansoprazole in bulk and drug formulations via Fe(III) and Zn(II) chelates.

PubMed

Rahman, Nafisur; Kashif, Mohammad

2010-03-01

Point and interval hypothesis tests performed to validate two simple and economical, kinetic spectrophotometric methods for the assay of lansoprazole are described. The methods are based on the formation of chelate complex of the drug with Fe(III) and Zn(II). The reaction is followed spectrophotometrically by measuring the rate of change of absorbance of coloured chelates of the drug with Fe(III) and Zn(II) at 445 and 510 nm, respectively. The stoichiometric ratio of lansoprazole to Fe(III) and Zn(II) complexes were found to be 1:1 and 2:1, respectively. The initial-rate and fixed-time methods are adopted for determination of drug concentrations. The calibration graphs are linear in the range 50-200 µg ml⁻¹ (initial-rate method), 20-180 µg ml⁻¹ (fixed-time method) for lansoprazole-Fe(III) complex and 120-300 (initial-rate method), and 90-210 µg ml⁻¹ (fixed-time method) for lansoprazole-Zn(II) complex. The inter-day and intra-day precision data showed good accuracy and precision of the proposed procedure for analysis of lansoprazole. The point and interval hypothesis tests indicate that the proposed procedures are not biased. Copyright © 2010 John Wiley & Sons, Ltd.

[Determination of blood alcohol among aviation personnel: proposed operative protocol].

PubMed

Lopez, A; Cardoni, F; Bova, M; Simonazzi, S; Romolo, F S; Ricciardi Tenore, G

2003-01-01

The problems of the use/abuse of alcohol need a special attention by the Public Authorities, based on the scientific evidences related to the subject. We would like to define in the present paper the procedures for alcohol testing (and drug testing) in the sailors, following the international aviation authorities (ICAO, JAR-OPS-1, FAA) recommendations. A Working Group was established to study both the scientific and the legal aspects of the problems related to alcohol testing in Italy. Experts from the Università "La Sapienza" and from Alitalia studied the alcohol testing issues abroad to set out criteria, guidelines and procedures for random testing in Italy.

Evaluation of multiple comparison correction procedures in drug assessment studies using LORETA maps.

PubMed

Alonso, Joan Francesc; Romero, Sergio; Mañanas, Miguel Ángel; Rojas, Mónica; Riba, Jordi; Barbanoj, Manel José

2015-10-01

The identification of the brain regions involved in the neuropharmacological action is a potential procedure for drug development. These regions are commonly determined by the voxels showing significant statistical differences after comparing placebo-induced effects with drug-elicited effects. LORETA is an electroencephalography (EEG) source imaging technique frequently used to identify brain structures affected by the drug. The aim of the present study was to evaluate different methods for the correction of multiple comparisons in the LORETA maps. These methods which have been commonly used in neuroimaging and also simulated studies have been applied on a real case of pharmaco-EEG study where the effects of increasing benzodiazepine doses on the central nervous system measured by LORETA were investigated. Data consisted of EEG recordings obtained from nine volunteers who received single oral doses of alprazolam 0.25, 0.5, and 1 mg, and placebo in a randomized crossover double-blind design. The identification of active regions was highly dependent on the selected multiple test correction procedure. The combined criteria approach known as cluster mass was useful to reveal that increasing drug doses led to higher intensity and spread of the pharmacologically induced changes in intracerebral current density.

Intracranial Self-Stimulation to Evaluate Abuse Potential of Drugs

PubMed Central

Miller, Laurence L.

2014-01-01

Intracranial self-stimulation (ICSS) is a behavioral procedure in which operant responding is maintained by pulses of electrical brain stimulation. In research to study abuse-related drug effects, ICSS relies on electrode placements that target the medial forebrain bundle at the level of the lateral hypothalamus, and experimental sessions manipulate frequency or amplitude of stimulation to engender a wide range of baseline response rates or response probabilities. Under these conditions, drug-induced increases in low rates/probabilities of responding maintained by low frequencies/amplitudes of stimulation are interpreted as an abuse-related effect. Conversely, drug-induced decreases in high rates/probabilities of responding maintained by high frequencies/amplitudes of stimulation can be interpreted as an abuse-limiting effect. Overall abuse potential can be inferred from the relative expression of abuse-related and abuse-limiting effects. The sensitivity and selectivity of ICSS to detect abuse potential of many classes of abused drugs is similar to the sensitivity and selectivity of drug self-administration procedures. Moreover, similar to progressive-ratio drug self-administration procedures, ICSS data can be used to rank the relative abuse potential of different drugs. Strengths of ICSS in comparison with drug self-administration include 1) potential for simultaneous evaluation of both abuse-related and abuse-limiting effects, 2) flexibility for use with various routes of drug administration or drug vehicles, 3) utility for studies in drug-naive subjects as well as in subjects with controlled levels of prior drug exposure, and 4) utility for studies of drug time course. Taken together, these considerations suggest that ICSS can make significant contributions to the practice of abuse potential testing. PMID:24973197

Extended Heroin Access Increases Heroin Choices Over a Potent Nondrug Alternative

PubMed Central

Lenoir, Magalie; Cantin, Lauriane; Vanhille, Nathalie; Serre, Fuschia; Ahmed, Serge H

2013-01-01

Epidemiological research shows that the proportion of drug users who become addicted to heroin is higher than to cocaine. Here we tested whether this difference could be due to a difference in the addiction liability between the two drugs. Addiction liability was assessed under a discrete-trials choice procedure by measuring the proportion of rats that prefer the drug over a potent alternative reward (ie, water sweetened with saccharin). Previous research on choice between self-administration of i.v. cocaine or sweet water showed that the proportion of cocaine-preferring rats remains relatively low and invariable (ie, 15%), even after extended drug access and regardless of past drug consumption (ie, total drug use before choice testing). By contrast, the present study shows that under similar choice conditions, the proportion of heroin-preferring rats considerably increases with extended heroin access (6–9 h per day for several weeks) and with past heroin consumption, from 11 to 51% at the highest past drug consumption level. At this level, the proportion of drug-preferring rats was about three times higher with heroin than with cocaine (51% vs 15%). This increase in the rate of heroin preference after extended heroin access persisted even after recovery from acute heroin withdrawal. Overall, these findings show that choice procedures are uniquely sensitive to different drugs and suggest that heroin is more addictive than cocaine. This higher addiction liability may contribute to explain why more drug users become addicted to heroin than to cocaine in epidemiological studies. PMID:23322185

75 FR 8528 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-25

... updated U.S. DOT Alcohol Testing Form (ATF) and the Management Information System (MIS) Data Collection... included a revised U.S. DOT Alcohol Testing Form (ATF) and the Management Information System (MIS) Data...) and Management Information System (MIS) form Federal Register [73 FR 14300] and [73 FR 33140]. There...

49 CFR 40.307 - What is the SAP's function in prescribing the employee's follow-up tests?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false What is the SAP's function in prescribing the employee's follow-up tests? 40.307 Section 40.307 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and...

49 CFR 40.307 - What is the SAP's function in prescribing the employee's follow-up tests?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What is the SAP's function in prescribing the employee's follow-up tests? 40.307 Section 40.307 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and...

49 CFR 40.307 - What is the SAP's function in prescribing the employee's follow-up tests?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false What is the SAP's function in prescribing the employee's follow-up tests? 40.307 Section 40.307 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and...

49 CFR 40.307 - What is the SAP's function in prescribing the employee's follow-up tests?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What is the SAP's function in prescribing the employee's follow-up tests? 40.307 Section 40.307 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and...

49 CFR 40.307 - What is the SAP's function in prescribing the employee's follow-up tests?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false What is the SAP's function in prescribing the employee's follow-up tests? 40.307 Section 40.307 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and...

Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals

PubMed Central

Lieu, Dustin; Asatryan, Liana; Davies, Daryl L.

2016-01-01

Prior to testing novel therapeutics in humans, short and long term preclinical (i.e., animal), repetitive pharmacological and toxicological testing is required. In most cases, the preferred route of administration is via oral delivery. At the present time, oral delivery is mostly accomplished using an oral gavage procedure, in part, because it can achieve consistent and precise dosing in the animal model. Although this method is well established it does have complications that can result in a high rate of animal attrition. To this end, the procedure introduced here describes an alternative to the oral gavage method in which the desired drug is incorporated into a tastant, orally dissolving strip (ODS) that can simply be presented to the test animal where it is then rapidly taken up with minimal manipulation of the test subject. Herein, we demonstrate that preclinical, oral drug delivery using the ODS method represents a safe, convenient, and humane alternative to oral gavage. PMID:27078261

49 CFR 40.25 - Must an employer check on the drug and alcohol testing record of employees it is intending to use...

Code of Federal Regulations, 2010 CFR

2010-10-01

... Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL..., you must, after obtaining an employee's written consent, request the information about the employee... the employee to perform safety-sensitive functions. (b) You must request the information listed in...

Quantitative Method for Analysis of Hydrocodone, Hydromorphone and Norhydrocodone in Human Plasma by Liquid Chromatography-tandem Mass Spectrometry

DTIC Science & Technology

2013-03-01

ratio ranges obtained for the six standards. Twelve samples were analyzed to demonstrate the efficiency of the extraction procedure. Drug and internal...frozen (−70 ◦C). Refrigerated samples were tested after 2 months of storage ; frozen samples were tested for up to 1 year from stor- age date. The...freeze–thaw stability was evaluated by analyzing three subject samples with known drug concentrations and two quality control samples at concentrations

A Course in Chemical Pharmacology.

ERIC Educational Resources Information Center

Volker, Eugene J.

1989-01-01

Describes a course provided for health profession-oriented students. Uses a chemical basis to explain the physiology of drug action while considering appropriate patient care. Outlines course content and testing procedures. (Author)

DUID prevalence in Colorado's DUI citations.

PubMed

Wood, Ed; Salomonsen-Sautel, Stacy

2016-06-01

There are limited studies that measure the prevalence of driving under the influence of drugs (DUID) based upon impairment measures because most prevalence studies are based on drug tests. The aim of this study was to provide the first estimate of DUID prevalence in Colorado using data collected by Colorado law enforcement officers in vehicular homicide (VH) and vehicular assault (VA) cases, and reported in court records. The four research questions of this study were answered by completing independent t-tests or Mann-Whitney U tests, Pearson chi-square analyses or Fisher's exact tests, and Kruskal-Wallis tests. Seventy percent (119 out of 170) of the cases involved alcohol only and 30% (51 out of 170) involved drugs. Of the latter cases, 32 cases involved a combination of alcohol and drugs and 19 cases identified drugs only, with no alcohol. Marijuana was the most commonly cited drug (23 cases); however, it was the sole impairing substance identified in only three cases. Polydrug use was very common among DUID cases, which makes it difficult to identify which drug or drugs caused the impairment responsible for the Driving Under the Influence citation. This study revealed tha (a) drugged driving is a frequent cause of DUI citations in cases charged with VH or VA; (b) that polydrug use, rather than marijuana, is the most common cause of drugged driving in Colorado; and (c) that current warrant procedures render blood test results meaningless in cases of marijuana-impairment. States should collect and analyze DUID data to ensure legislators focus on the right DUID problems to improve biological testing for drugs, adopt more appropriate roadside testing, and enact stronger DUID laws to protect the public. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

49 CFR 40.171 - How does an employee request a test of a split specimen?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false How does an employee request a test of a split specimen? 40.171 Section 40.171 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Split Specimen Tests § 40.171 How does an employee request a test of a split specimen? (a...

Spice drugs are more than harmless herbal blends: a review of the pharmacology and toxicology of synthetic cannabinoids

PubMed Central

Seely, Kathryn A.; Lapoint, Jeff; Moran, Jeffery H.; Fattore, Liana

2014-01-01

“K2” and “Spice” drugs (collectively hereafter referred to as Spice) represent a relatively new class of designer drugs that have recently emerged as popular alternatives to marijuana, otherwise characterized as “legal highs”. These drugs are readily available on the Internet and sold in many head shops and convenience stores under the disguise of innocuous products like herbal blends, incense, or air fresheners. Although package labels indicate “not for human consumption”, the number of intoxicated people presenting to emergency departments is dramatically increasing. The lack of validated and standardized human testing procedures and an endless supply of potential drugs of abuse are primary reasons why researchers find it difficult to fully characterize clinical consequences associated with Spice. While the exact chemical composition and toxicology of Spice remains to be determined, there is mounting evidence identifying several synthetic cannabinoids as causative agents responsible for psychoactive and adverse physical effects. This review provides updates of the legal status of common synthetic cannabinoids detected in Spice and analytical procedures used to test Spice products and human specimens collected under a variety of clinical circumstances. The pharmacological and toxicological consequences of synthetic cannabinoid abuse are also reviewed to provide a future perspective on potential short- and long-term implications. PMID:22561602

Biodistribution of doxorubicin and nanostructured ferrocarbon carrier particles in organism during magnetically controlled drug delivery

NASA Astrophysics Data System (ADS)

Kuznetsov, Anatoly A.; Filippov, Victor I.; Nikolskaya, Tatiana A.; Budko, Andrei P.; Kovarskii, Alexander L.; Zontov, Sergei V.; Kogan, Boris Ya.; Kuznetsov, Oleg A.

2009-05-01

Biodistribution of doxorubicin and ferrocarbon carrier particles in organism during and after magnetically controlled anti-tumor drug delivery and deposition was studied. Animal tests show high concentration of the cytostatic drug in the target zone, while its concentration is three orders of magnitude lower in bloodstream and other organs. A significant depot of the drug remains on the deposited particles days after the procedure. Macrophages actively phagocytose the ferrocarbon (FeC) particles and remain viable long enough to carry them to the lymph nodes.

Enhanced Chronic Pain Management Utilizing Chemokine Receptor Antagonists

DTIC Science & Technology

2016-08-01

approximately halfway into the solution. All animals were tested at 60, 15 and 0 min before drug injection. For each animal , the first reading was discarded...approval (December 31, 2015), hiring new personnel, conducting baseline testing for procedures not involving animals , testing equipment, developing...treatment; Analgesia; Nociception; Antinociception; Inflammation; Chemokines; Chemokine receptor antagonists; Opioid analgesics; Animal models of pain

The need for drugged driving per se laws: a commentary.

PubMed

DuPont, Robert L; Voas, Robert B; Walsh, J Michael; Shea, Corinne; Talpins, Stephen K; Neil, Mark M

2012-01-01

Triggered by the new federal commitment announced by the Office of National Drug Control Policy (ONCDP) to encourage states to enact drugged driving per se laws, this article reviews the reasons to establish such laws and the issues that may arise when trying to enforce them. A review of the state of drunk driving per se laws and their implications for drugged driving is presented, with a review of impaired driving enforcement procedures and drug testing technology. Currently, enforcement of drugged driving laws is an adjunct to the enforcement of laws regarding alcohol impairment. Drivers are apprehended when showing signs of alcohol intoxication and only in the relatively few cases where the blood alcohol concentration of the arrested driver does not account for the observed behavior is the possibility of drug impairment pursued. In most states, the term impaired driving covers both alcohol and drug impairment; thus, driver conviction records may not distinguish between the two different sources of impairment. As a result, enforcement statistics do not reflect the prevalence of drugged driving. Based on the analysis presented, this article recommends a number of steps that can be taken to evaluate current drugged driving enforcement procedures and to move toward the enactment of drug per se laws.

Viewpoint: observations on scaled average bioequivalence.

PubMed

Patterson, Scott D; Jones, Byron

2012-01-01

The two one-sided test procedure (TOST) has been used for average bioequivalence testing since 1992 and is required when marketing new formulations of an approved drug. TOST is known to require comparatively large numbers of subjects to demonstrate bioequivalence for highly variable drugs, defined as those drugs having intra-subject coefficients of variation greater than 30%. However, TOST has been shown to protect public health when multiple generic formulations enter the marketplace following patent expiration. Recently, scaled average bioequivalence (SABE) has been proposed as an alternative statistical analysis procedure for such products by multiple regulatory agencies. SABE testing requires that a three-period partial replicate cross-over or full replicate cross-over design be used. Following a brief summary of SABE analysis methods applied to existing data, we will consider three statistical ramifications of the proposed additional decision rules and the potential impact of implementation of scaled average bioequivalence in the marketplace using simulation. It is found that a constraint being applied is biased, that bias may also result from the common problem of missing data and that the SABE methods allow for much greater changes in exposure when generic-generic switching occurs in the marketplace. Copyright © 2011 John Wiley & Sons, Ltd.

Comparison of design strategies for a three-arm clinical trial with time-to-event endpoint: Power, time-to-analysis, and operational aspects.

PubMed

Asikanius, Elina; Rufibach, Kaspar; Bahlo, Jasmin; Bieska, Gabriele; Burger, Hans Ulrich

2016-11-01

To optimize resources, randomized clinical trials with multiple arms can be an attractive option to simultaneously test various treatment regimens in pharmaceutical drug development. The motivation for this work was the successful conduct and positive final outcome of a three-arm randomized clinical trial primarily assessing whether obinutuzumab plus chlorambucil in patients with chronic lympocytic lymphoma and coexisting conditions is superior to chlorambucil alone based on a time-to-event endpoint. The inference strategy of this trial was based on a closed testing procedure. We compare this strategy to three potential alternatives to run a three-arm clinical trial with a time-to-event endpoint. The primary goal is to quantify the differences between these strategies in terms of the time it takes until the first analysis and thus potential approval of a new drug, number of required events, and power. Operational aspects of implementing the various strategies are discussed. In conclusion, using a closed testing procedure results in the shortest time to the first analysis with a minimal loss in power. Therefore, closed testing procedures should be part of the statistician's standard clinical trials toolbox when planning multiarm clinical trials. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A pragmatic definition of therapeutic synergy suitable for clinically relevant in vitro multicompound analyses.

PubMed

Kashif, Muhammad; Andersson, Claes; Åberg, Magnus; Nygren, Peter; Sjöblom, Tobias; Hammerling, Ulf; Larsson, Rolf; Gustafsson, Mats G

2014-07-01

For decades, the standard procedure when screening for candidate anticancer drug combinations has been to search for synergy, defined as any positive deviation from trivial cases like when the drugs are regarded as diluted versions of each other (Loewe additivity), independent actions (Bliss independence), or no interaction terms in a response surface model (no interaction). Here, we show that this kind of conventional synergy analysis may be completely misleading when the goal is to detect if there is a promising in vitro therapeutic window. Motivated by this result, and the fact that a drug combination offering a promising therapeutic window seldom is interesting if one of its constituent drugs can provide the same window alone, the largely overlooked concept of therapeutic synergy (TS) is reintroduced. In vitro TS is said to occur when the largest therapeutic window obtained by the best drug combination cannot be achieved by any single drug within the concentration range studied. Using this definition of TS, we introduce a procedure that enables its use in modern massively parallel experiments supported by a statistical omnibus test for TS designed to avoid the multiple testing problem. Finally, we suggest how one may perform TS analysis, via computational predictions of the reference cell responses, when only the target cell responses are available. In conclusion, the conventional error-prone search for promising drug combinations may be improved by replacing conventional (toxicology-rooted) synergy analysis with an analysis focused on (clinically motivated) TS. ©2014 American Association for Cancer Research.

An intravenous self-administration procedure for assessing the reinforcing effects of hallucinogens in nonhuman primates.

PubMed

Goodwin, Amy K

Self-administration procedures are the gold standard for investigating the reinforcing effects of drugs. The notable exception to good correspondence between laboratory self-administration studies and human drug taking behavior has historically been the classic hallucinogens. The present study used a well-established daily access procedure, followed by a novel intermittent access procedure, to investigate the reinforcing effects of LSD in baboons. Rates of self-injection in the daily access procedure were minimal. One baboon self-administered 0.001mg/kg and a second baboon self-administered 0.0032mg/kg above vehicle levels, though rates of self-injection were clearly low and neither of the two remaining baboons self-administered any LSD dose tested in the daily access procedure. Rates of self-injection using an intermittent access procedure with discriminative stimuli resulted in two doses of LSD being self-administered above vehicle levels in two of three baboons tested (0.01 and 0.032mg/kg in one baboon; 0.0032 and 0.01mg/kg in a second). In addition, the number of self-injections at these doses was higher (range=3-6 injections) in the intermittent access procedure than in the daily access procedure (range=1-2 injections). The present study is the first to demonstrate LSD self-administration in a laboratory animal, and though the results are limited, they indicate intermittent access procedures with discriminative stimuli may provide a reliable and valid method for investigating the reinforcing effects of IV self-administered hallucinogens in laboratory animals. The usefulness of such procedures should be further evaluated in a larger number of subjects. Copyright © 2016. Published by Elsevier Inc.

Oral surgery in patients under antithrombotic therapy: perioperative bleeding as a significant risk factor for postoperative hemorrhage.

PubMed

Rocha, Amanda L; Souza, Alessandra F; Martins, Maria A P; Fraga, Marina G; Travassos, Denise V; Oliveira, Ana C B; Ribeiro, Daniel D; Silva, Tarcília A

2018-01-01

: To investigate perioperative and postoperative bleeding, complications in patients under therapy with anticoagulant or antiplatelet drugs submitted to oral surgery. To evaluate the risk of bleeding and safety for dental surgery, a retrospective chart review was performed. Medical and dental records of patients taking oral antithrombotic drugs undergoing dental surgery between 2010 and 2015 were reviewed. Results were statistically analyzed using Fisher's exact test, t test or the χ test. One hundred and seventy-nine patients underwent 293 surgical procedures. A total of eight cases of perioperative and 12 episodes of postoperative bleeding were documented. The complications were generally managed with local measures and did not require hospitalization. We found significant association of postoperative hemorrhage with increased perioperative bleeding (P = 0.043) and combination of anticoagulant and antiplatelet therapy (P < 0.001). The chance of postoperative hemorrhage for procedures with increased perioperative bleeding is 8.8 times bigger than procedures without perioperative bleeding. Dental surgery in patients under antithrombotic therapy might be carried out without altering the regimen because of low risk of perioperative and postoperative bleeding. However, patients with increased perioperative bleeding should be closely followed up because of postoperative complications risk.

Fluorescent Immortalized Human Adipose Derived Stromal Cells (hASCs-TS/GFP+) for Studying Cell Drug Delivery Mediated by Microvesicles.

PubMed

Cocce, Valentina; Balducci, Luigi; Falchetti, Maria L; Pascucci, Luisa; Ciusani, Emilio; Brini, Anna T; Sisto, Francesca; Piovani, Giovanna; Alessandri, Giulio; Parati, Eugenio; Cabeza, Laura; Pessina, Augusto

2017-11-24

A new tool for the drug delivery is based on the use of Mesenchymal Stromal Cells (MSCs) loaded in vitro with anti-cancer drugs. Unfortunately, the restricted lifespan of MSCs represents a significant limitation to produce them in high amounts and for long time studies. Immortalized MSCs from adipose tissue (hASCs) have been generated as good source of cells with stable features. These cells could improve the development of standardized procedures for both in vitro and preclinical studies. Furthermore they facilitate procedures for preparing large amounts of secretome containing microvesicles (MVs). We used human adipose tissue derived MSCs immortalized with hTERT+SV40 (TS) genes and transfected with GFP (hASCs-TS/GFP+). This line was investigated for its ability to uptake and release anticancer drugs. Microvesicles associated to paclitaxel (MVs/PTX) were isolated, quantified, and tested on pancreatic cancer cells. The line hASCs-TS/GFP+ maintained the main mesenchymal characters and was able to uptake and release, in active form, both paclitaxel and gemcitabine. From paclitaxel loaded hASCs-TS/GFP+ cells were isolated microvesicles in sufficient amount to inhibit "in vitro" the proliferation of pancreatic tumor cells. Our study suggests that human immortalized MSCs could be used for a large scale production of cells for mediated drug delivery. Moreover, the secretion of drug-associated MVs could represent a new way for producing new drug formulation by "biogenesis". In the context of the "advanced cell therapy procedure", the MVs/PTX production would use less resource and time and it could possibly contribute to simplification of GMP procedures. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

[Modern Diagnosis and Therapy of the rhinitis allergica].

PubMed

Hauswald, B; Yarin, Y M

2015-05-01

The prevalence of allergic diseases is increasing worldwide. The highest increase rate is observed in rhinitis allergica. Apart from the anamnesis, the diagnosis relies mainly on skin tests, laboratory analyses and if necessary provocation tests. Symptomatic and causal therapy with abstention and specific immunotherapy are available as therapeutic means. Specific immunotherapy should be aspired as the method of choice. It is comprised of subcutane and sublingular immunity therapy. Usually native allergens and allergoids are used as therapeutics. Recombinant allergens are currently under development. Modern therapy procedures involving these drugs consist of year-round or pre- and co-seasonal treatment which spans at least 3-4 years. In cases of polyvalent allergy, different types of drugs and therapy procedures can be combined. The future of rhinitis allergica treatment lies in further development of specific immunotherapy. © Georg Thieme Verlag KG Stuttgart · New York.

Multinational experience with hypersensitivity drug reactions in Latin America.

PubMed

Jares, Edgardo José; Sánchez-Borges, Mario; Cardona-Villa, Ricardo; Ensina, Luis Felipe; Arias-Cruz, Alfredo; Gómez, Maximiliano; Barayazarra, Susana; Bernstein, Jonathan A; Serrano, Carlos D; Cuello, Mabel Noemi; Morfin-Maciel, Blanca María; De Falco, Alicia; Cherrez-Ojeda, Iván

2014-09-01

Epidemiologic drug allergy data from Latin America are scarce, and there are no studies on specific procedures focusing on this topic in Latin America. To assess the clinical characteristics and management of hypersensitivity drug reactions in different Latin American countries. An European Network of Drug Allergy questionnaire survey was implemented in 22 allergy units in 11 Latin American countries to report on consecutive patients who presented with a suspected hypersensitivity drug reaction. Each unit used its own protocols to investigate patients. Included were 868 hypersensitivity drug reactions in 862 patients (71% of adults and elderly patients were women and 51% of children were girls, P = .0001). Children presented with less severe reactions than adults and elderly patients (P < .0001). Urticaria and angioedema accounted for the most frequent clinical presentations (71%), whereas anaphylaxis was present in 27.3% of cases. There were no deaths reported. Nonsteroidal anti-inflammatory drugs (52.3%), β-lactam antibiotics (13.8%), and other antibiotics (10.1%) were the drugs used most frequently. Skin prick tests (16.7%) and provocation tests (34.2%) were the study procedures most commonly used. A large proportion of patients were treated in the emergency department (62%) with antihistamines (68%) and/or corticosteroids (53%). Only 22.8% of patients presenting with anaphylaxis received epinephrine. Nonsteroidal anti-inflammatory drugs and antibiotics were the drugs used in at least 75% of patients. More than half the reactions were treated in the emergency department, whereas epinephrine was administered in fewer than 25% of patients with anaphylaxis. Dissemination of guidelines for anaphylaxis among primary and emergency department physicians should be encouraged. Copyright © 2014 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Preclinical Determinants of Drug Choice under Concurrent Schedules of Drug Self-Administration

PubMed Central

Banks, Matthew L.; Negus, S. Stevens

2012-01-01

Drug self-administration procedures have played a critical role in the experimental analysis of psychoactive compounds, such as cocaine, for over 50 years. While there are numerous permutations of this procedure, this paper will specifically focus on choice procedures using concurrent schedules of intravenous drug self-administration. The aims of this paper are to first highlight the evolution of drug choice procedures and then review the subsequent preclinical body of literature utilizing these choice procedures to understand the environmental, pharmacological, and biological determinants of the reinforcing stimulus effects of drugs. A main rationale for this paper is our proposition that choice schedules are underutilized in investigating the reinforcing effects of drugs in assays of drug self-administration. Moreover, we will conclude with potential future directions and unexplored scientific space for the use of drug choice procedures. PMID:23243420

Testing equality and interval estimation in binary responses when high dose cannot be used first under a three-period crossover design.

PubMed

Lui, Kung-Jong; Chang, Kuang-Chao

2015-01-01

When comparing two doses of a new drug with a placebo, we may consider using a crossover design subject to the condition that the high dose cannot be administered before the low dose. Under a random-effects logistic regression model, we focus our attention on dichotomous responses when the high dose cannot be used first under a three-period crossover trial. We derive asymptotic test procedures for testing equality between treatments. We further derive interval estimators to assess the magnitude of the relative treatment effects. We employ Monte Carlo simulation to evaluate the performance of these test procedures and interval estimators in a variety of situations. We use the data taken as a part of trial comparing two different doses of an analgesic with a placebo for the relief of primary dysmenorrhea to illustrate the use of the proposed test procedures and estimators.

Annual banned-substance review: analytical approaches in human sports drug testing.

PubMed

Thevis, Mario; Kuuranne, Tiia; Geyer, Hans; Schänzer, Wilhelm

2015-01-01

Within the mosaic display of international anti-doping efforts, analytical strategies based on up-to-date instrumentation as well as most recent information about physiology, pharmacology, metabolism, etc., of prohibited substances and methods of doping are indispensable. The continuous emergence of new chemical entities and the identification of arguably beneficial effects of established or even obsolete drugs on endurance, strength, and regeneration, necessitate frequent and adequate adaptations of sports drug testing procedures. These largely rely on exploiting new technologies, extending the substance coverage of existing test protocols, and generating new insights into metabolism, distribution, and elimination of compounds prohibited by the World Anti-Doping Agency (WADA). In reference of the content of the 2014 Prohibited List, literature concerning human sports drug testing that was published between October 2013 and September 2014 is summarized and reviewed in this annual banned-substance review, with particular emphasis on analytical approaches and their contribution to enhanced doping controls. Copyright © 2014 John Wiley & Sons, Ltd.

49 CFR 40.181 - What does the second laboratory do with the split specimen when it is tested to reconfirm a...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What does the second laboratory do with the split specimen when it is tested to reconfirm a substituted test result? 40.181 Section 40.181 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Split Specimen Tests § 40.181...

49 CFR 40.179 - What does the second laboratory do with the split specimen when it is tested to reconfirm an...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What does the second laboratory do with the split specimen when it is tested to reconfirm an adulterated test result? 40.179 Section 40.179 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Split Specimen Tests § 40.17...

49 CFR 40.173 - Who is responsible for paying for the test of a split specimen?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false Who is responsible for paying for the test of a split specimen? 40.173 Section 40.173 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Split Specimen Tests § 40.173 Who is responsible for paying for the test of a spli...

21 CFR 314.201 - Procedure for hearings.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Procedure for hearings. 314.201 Section 314.201 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Hearing Procedures for New Drugs...

Drug metabolism and hypersensitivity reactions to drugs.

PubMed

Agúndez, José A G; Mayorga, Cristobalina; García-Martin, Elena

2015-08-01

The aim of the present review was to discuss recent advances supporting a role of drug metabolism, and particularly of the generation of reactive metabolites, in hypersensitivity reactions to drugs. The development of novel mass-spectrometry procedures has allowed the identification of reactive metabolites from drugs known to be involved in hypersensitivity reactions, including amoxicillin and nonsteroidal antiinflammatory drugs such as aspirin, diclofenac or metamizole. Recent studies demonstrated that reactive metabolites may efficiently bind plasma proteins, thus suggesting that drug metabolites, rather than - or in addition to - parent drugs, may elicit an immune response. As drug metabolic profiles are often determined by variability in the genes coding for drug-metabolizing enzymes, it is conceivable that an altered drug metabolism may predispose to the generation of reactive drug metabolites and hence to hypersensitivity reactions. These findings support the potential for the use of pharmacogenomics tests in hypersensitivity (type B) adverse reactions, in addition to the well known utility of these tests in type A adverse reactions. Growing evidence supports a link between genetically determined drug metabolism, altered metabolic profiles, generation of highly reactive metabolites and haptenization. Additional research is required to developing robust biomarkers for drug-induced hypersensitivity reactions.

Tested Demonstrations.

ERIC Educational Resources Information Center

Gilbert, George L., Ed.

1985-01-01

Background information, procedures, and typical results obtained are provided for two demonstrations. The first involves the colorful complexes of copper(II). The second involves reverse-phase separation of Food, Drug, and Cosmetic (FD & C) dyes using a solvent gradient. (JN)

49 CFR 40.19 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false [Reserved] 40.19 Section 40.19 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Employer Responsibilities § 40.19 [Reserved] ...

Screening Tests for Women Who Have Heart Disease

MedlinePlus

... treatment to restore blood flow to the heart. ASPIRIN: TAKE WITH CAUTION This well-known "wonder drug" ... artery-opening procedure, such as angioplasty. In addition, aspirin is given to people who arrive at a ...

49 CFR 40.145 - On what basis does the MRO verify test results involving adulteration or substitution?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false On what basis does the MRO verify test results involving adulteration or substitution? 40.145 Section 40.145 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process §...

49 CFR 40.127 - What are the MRO's functions in reviewing negative test results?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What are the MRO's functions in reviewing negative test results? 40.127 Section 40.127 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.127 What are the MRO's...

EXTENDED ACCESS TO METHAMPHETAMINE SELF-ADMINISTRATION AFFECTS SENSORIMOTOR GATING IN RATS

PubMed Central

Hadamitzky, Martin; Markou, Athina; Kuczenski, Ronald

2010-01-01

Disturbed information processing observed in neuropsychiatric disorders is reflected by deficient sensorimotor gating, measured as prepulse inhibition (PPI) of the acoustic startle response (ASR). Long-term, higher-dose methamphetamine (METH) abuse patterns are associated with cognitive impairments, mania and/or schizophrenia-like psychosis. The present study investigated in rats METH-induced impairment of sensorimotor gating using an intravenous self-administration (IVSA) escalating dose procedure. In this procedure, rats escalated drug intake during weekly extended access periods to METH IVSA (1, 3, and 6-h), where PPI was assessed after each access period and thus at various times of drug exposure. Despite increased drug intake over the course of extended access to METH, disruption of sensorimotor gating was only seen after the access period of 6-h. The data suggest that METH-induced impairment of sensorimotor gating in IVSA-tasks is rather attributed to continuous and higher-dose exposure than to actual amounts of drug present at the time of testing. IVSA procedures, comprising stepwise stimulant escalation may serve as a useful translational model in rats that approximate important aspects of human abuse pattern in the context of stimulant-induced cognitive and behavioral deficits. PMID:21070821

The behavioral economics of drug self-administration: A review and new analytical approach for within-session procedures

PubMed Central

Bentzley, Brandon S.; Fender, Kimberly M.; Aston-Jones, Gary

2012-01-01

Rationale Behavioral-economic demand curve analysis offers several useful measures of drug self-administration. Although generation of demand curves previously required multiple days, recent within-session procedures allow curve construction from a single 110-min cocaine self-administration session, making behavioral-economic analyses available to a broad range of self-administration experiments. However, a mathematical approach of curve fitting has not been reported for the within-session threshold procedure. Objectives We review demand curve analysis in drug self-administration experiments and provide a quantitative method for fitting curves to single-session data that incorporates relative stability of brain drug concentration. Methods Sprague-Dawley rats were trained to self-administer cocaine, and then tested with the threshold procedure in which the cocaine dose was sequentially decreased on a fixed ratio-1 schedule. Price points (responses/mg cocaine) outside of relatively stable brain cocaine concentrations were removed before curves were fit. Curve-fit accuracy was determined by the degree of correlation between graphical and calculated parameters for cocaine consumption at low price (Q0) and the price at which maximal responding occurred (Pmax). Results Removing price points that occurred at relatively unstable brain cocaine concentrations generated precise estimates of Q0 and resulted in Pmax values with significantly closer agreement with graphical Pmax than conventional methods. Conclusion The exponential demand equation can be fit to single-session data using the threshold procedure for cocaine self-administration. Removing data points that occur during relatively unstable brain cocaine concentrations resulted in more accurate estimates of demand curve slope than graphical methods, permitting a more comprehensive analysis of drug self-administration via a behavioral-economic framework. PMID:23086021

Voluntary Co-Consumption of Alcohol and Nicotine: Effects of Abstinence, Intermittency, and Withdrawal in Mice

PubMed Central

O’Rourke, Kyu Y.; Touchette, Jillienne C.; Hartell, Elizabeth C.; Bade, Elizabeth J.; Lee, Anna M.

2018-01-01

Alcohol and nicotine are often used together, and there is a high rate of co-occurrence between alcohol and nicotine addiction. Most animal models studying alcohol and nicotine interactions have utilized passive drug administration, which may not be relevant to human co-addiction. In addition, the interactions between alcohol and nicotine in female animals have been understudied, as most studies have used male animals. To address these issues, we developed models of alcohol and nicotine co-consumption in male and female mice that utilized voluntary, oral consumption of unsweetened alcohol, nicotine and water. We first examined drug consumption and preference in single-drug, sequential alcohol and nicotine consumption tests in male and female C57BL/6 and DBA/2J mice. We then tested chronic continuous and intermittent access alcohol and nicotine co-consumption procedures. We found that male and female C57BL/6 mice readily co-consumed unsweetened alcohol and nicotine. In our continuous co-consumption procedures, we found that varying the available nicotine concentration during an alcohol abstinence period affected compensatory nicotine consumption during alcohol abstinence, and affected rebound alcohol consumption when alcohol was re-introduced. Consumption of alcohol and nicotine in an intermittent co-consumption procedure produced higher alcohol consumption levels, but not nicotine consumption levels, compared with the continuous co-consumption procedures. Finally, we found that intermittent alcohol and nicotine co-consumption resulted in physical dependence. Our data show that these voluntary co-consumption procedures can be easily performed in mice and can be used to study behavioral interactions between alcohol and nicotine consumption, which may better model human alcohol and nicotine co-addiction. PMID:27342124

Standard operation procedures for conducting the on-the-road driving test, and measurement of the standard deviation of lateral position (SDLP).

PubMed

Verster, Joris C; Roth, Thomas

2011-01-01

This review discusses the methodology of the standardized on-the-road driving test and standard operation procedures to conduct the test and analyze the data. The on-the-road driving test has proven to be a sensitive and reliable method to examine driving ability after administration of central nervous system (CNS) drugs. The test is performed on a public highway in normal traffic. Subjects are instructed to drive with a steady lateral position and constant speed. Its primary parameter, the standard deviation of lateral position (SDLP), ie, an index of 'weaving', is a stable measure of driving performance with high test-retest reliability. SDLP differences from placebo are dose-dependent, and do not depend on the subject's baseline driving skills (placebo SDLP). It is important that standard operation procedures are applied to conduct the test and analyze the data in order to allow comparisons between studies from different sites.

A Study on the Reliability of an On-Site Oral Fluid Drug Test in a Recreational Context

PubMed Central

Gentili, Stefano; Tittarelli, Roberta; Mannocchi, Giulio

2016-01-01

The reliability of DrugWipe 5A on site test for principal drugs of abuse (cannabis, amphetamines, cocaine, and opiates) detection in oral fluid was assessed by comparing the on-site results with headspace solid-phase microextraction (HS-SPME) gas chromatography-mass spectrometry (GC-MS) analysis on samples extracted by the device collection pad. Oral fluid samples were collected at recreational settings (e.g., discos, pubs, and music bars) of Rome metropolitan area. Eighty-three club goers underwent the on-site drug screening test with one device. Independently from the result obtained, a second device was used just to collect another oral fluid sample subsequently extracted and analyzed in the laboratory following HS-SPME procedure, gas chromatographic separation by a capillary column, and MS detection by electron impact ionization. DrugWipe 5A on-site test showed 54 samples (65.1%) positive to one or more drugs of abuse, whereas 75 samples (90.4%) tested positive for one or more substances following GC-MS assay. Comparing the obtained results, the device showed sensitivity, specificity, and accuracy around 80% for amphetamines class. Sensitivity (67 and 50%) was obtained for cocaine and opiates, while both sensitivity and accuracy were unsuccessful (29 and 53%, resp.) for cannabis, underlying the limitation of the device for this latter drug class. PMID:27610266

A long journey from minimum inhibitory concentration testing to clinically predictive breakpoints: deterministic and probabilistic approaches in deriving breakpoints.

PubMed

Dalhoff, A; Ambrose, P G; Mouton, J W

2009-08-01

Since the origin of an "'International Collaborative Study on Antibiotic Sensitivity Testing'" in 1971, considerable advancement has been made to standardize clinical susceptibility testing procedures of antimicrobial agents. However, a consensus on the methods to be used and interpretive criteria was not reached, so the results of susceptibility testing were discrepant. Recently, the European Committee on Antimicrobial Susceptibility Testing achieved a harmonization of existing methods for susceptibility testing and now co-ordinates the process for setting breakpoints. Previously, breakpoints were set by adjusting the mean pharmacokinetic parameters derived from healthy volunteers to the susceptibilities of a population of potential pathogens expressed as the mean minimum inhibitory concentration (MIC) or MIC90%. Breakpoints derived by the deterministic approach tend to be too high, since this procedure does not take the variabilities of drug exposure and the susceptibility patterns into account. Therefore, first-step mutants or borderline susceptible bacteria may be considered as fully susceptible. As the drug exposure of such sub-populations is inadequate, resistance development will increase and eradication rates will decrease, resulting in clinical failure. The science of pharmacokinetics/pharmacodynamics integrates all possible drug exposures for standard dosage regimens and all MIC values likely to be found for the clinical isolates into the breakpoint definitions. Ideally, the data sets used originate from patients suffering from the disease to be treated. Probability density functions for both the pharmacokinetic and microbiological variables are determined, and a large number of MIC/drug exposure scenarios are calculated. Therefore, this method is defined as the probabilistic approach. The breakpoints thus derived are lower than the ones defined deterministically, as the entire range of probable drug exposures from low to high is modeled. Therefore, the amplification of drug-resistant sub-populations will be reduced. It has been a long journey since the first attempts in 1971 to define breakpoints. Clearly, this implies that none of the various approaches is right or wrong, and that the different approaches reflect different philosophies and mirror the tremendous progress made in the understanding of the pharmacodynamic properties of different classes of antimicrobials.

Factors influencing behavior in the forced swim test

PubMed Central

Bogdanova, Olena V.; Kanekar, Shami; D’Anci, Kristen E.; Renshaw, Perry F.

2017-01-01

The forced swim test (FST) is a behavioral test in rodents which was developed in 1978 by Porsolt and colleagues as a model for predicting the clinical efficacy of antidepressant drugs. A modified version of the FST added the classification of active behaviors into swimming and climbing, in order to facilitate the differentiation between serotonergic and noradrenergic classes of antidepressant drugs. The FST is now widely used in basic research and the pharmaceutical screening of potential antidepressant treatments. It is also one of the most commonly used tests to assess depressive-like behavior in animal models. Despite the simplicity and sensitivity of the FST procedure, important differences even in baseline immobility rates have been reported between different groups, which complicate the comparison of results across studies. In spite of several methodological papers and reviews published on the FST, the need still exists for clarification of factors which can influence the procedure. While most recent reviews have focused on antidepressant effects observed with the FST, this one considers the methodological aspects of the procedure, aiming to summarize issues beyond antidepressant action in the FST. The previously published literature is analyzed for factors which are known to influence animal behavior in the FST. These include biological factors, such as strain, age, body weight, gender and individual differences between animals; influence of preconditioning before the FST: handling, social isolation or enriched environment, food manipulations, various kinds of stress, endocrine manipulations and surgery; schedule and routes of treatment, dosage and type of the drugs as well as experimental design and laboratory environmental effects. Consideration of these factors in planning experiments may result in more consistent FST results. PMID:23685235

75 FR 8524 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-25

... drivers are kept from behind the wheel of a large truck until they are successfully rehabilitated.'' Other... with State laws without running afoul of Part 40. We have not created compliance responsibilities under...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

28 CFR 550.44 - Procedures for arranging drug counseling.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Procedures for arranging drug counseling... MANAGEMENT DRUG PROGRAMS Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.44 Procedures for arranging drug counseling. The contract center staff shall hold a program...

The quantitation of 2-oxo-3-hydroxy lysergic acid diethylamide (O-H-LSD) in human urine specimens, a metabolite of LSD: comparative analysis using liquid chromatography-selected ion monitoring mass spectrometry and liquid chromatography-ion trap mass spectrometry.

PubMed

Poch, G K; Klette, K L; Anderson, C

2000-04-01

This paper compares the potential forensic application of two sensitive and rapid procedures (liquid chromatography-mass spectrometry and liquid chromatography-ion trap mass spectrometry) for the detection and quantitation of 2-oxo-3-hydroxy lysergic acid diethylamide (O-H-LSD) a major LSD metabolite. O-H-LSD calibration curves for both procedures were linear over the concentration range 0-8,000 pg/mL with correlation coefficients (r2) greater than 0.99. The observed limit of detection (LOD) and limit of quantitation (LOQ) for O-H-LSD in both procedures was 400 pg/mL. Sixty-eight human urine specimens that had previously been found to contain LSD by gas chromatography-mass spectrometry were reanalyzed by both procedures for LSD and O-H-LSD. These specimens contained a mean concentration of O-H-LSD approximately 16 times higher than the LSD concentration. Because both LC methods produce similar results, either procedure can be readily adapted to O-H-LSD analysis for use in high-volume drug-testing laboratories. In addition, the possibility of significantly increasing the LSD detection time window by targeting this major LSD metabolite for analysis may influence other drug-free workplace programs to test for LSD.

Standard operation procedures for conducting the on-the-road driving test, and measurement of the standard deviation of lateral position (SDLP)

PubMed Central

Verster, Joris C; Roth, Thomas

2011-01-01

This review discusses the methodology of the standardized on-the-road driving test and standard operation procedures to conduct the test and analyze the data. The on-the-road driving test has proven to be a sensitive and reliable method to examine driving ability after administration of central nervous system (CNS) drugs. The test is performed on a public highway in normal traffic. Subjects are instructed to drive with a steady lateral position and constant speed. Its primary parameter, the standard deviation of lateral position (SDLP), ie, an index of ‘weaving’, is a stable measure of driving performance with high test–retest reliability. SDLP differences from placebo are dose-dependent, and do not depend on the subject’s baseline driving skills (placebo SDLP). It is important that standard operation procedures are applied to conduct the test and analyze the data in order to allow comparisons between studies from different sites. PMID:21625472

Outbreak of hepatitis C virus infection associated with narcotics diversion by an hepatitis C virus-infected surgical technician.

PubMed

Warner, Amy E; Schaefer, Melissa K; Patel, Priti R; Drobeniuc, Jan; Xia, Guoliang; Lin, Yulin; Khudyakov, Yury; Vonderwahl, Candace W; Miller, Lisa; Thompson, Nicola D

2015-01-01

Drug diversion by health care personnel poses a risk for serious patient harm. Public health identified 2 patients diagnosed with acute hepatitis C virus (HCV) infection who shared a common link with a hospital. Further investigation implicated a drug-diverting, HCV-infected surgical technician who was subsequently employed at an ambulatory surgical center. Patients at the 2 facilities were offered testing for HCV infection if they were potentially exposed. Serum from the surgical technician and patients testing positive for HCV but without evidence of infection before their surgical procedure was further tested to determine HCV genotype and quasi-species sequences. Parenteral medication handling practices at the 2 facilities were evaluated. The 2 facilities notified 5970 patients of their possible exposure to HCV, 88% of whom were tested and had results reported to the state public health departments. Eighteen patients had HCV highly related to the surgical technician's virus. The surgical technician gained unauthorized access to fentanyl owing to limitations in procedures for securing controlled substances. Public health surveillance identified an outbreak of HCV infection due to an infected health care provider engaged in diversion of injectable narcotics. The investigation highlights the value of public health surveillance in identifying HCV outbreaks and uncovering a method of drug diversion and its impacts on patients. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

Outbreak of hepatitis C virus infection associated with narcotics diversion by an hepatitis C virus–infected surgical technician

PubMed Central

Warner, Amy E.; Schaefer, Melissa K.; Patel, Priti R.; Drobeniuc, Jan; Xia, Guoliang; Lin, Yulin; Khudyakov, Yury; Vonderwahl, Candace W.; Miller, Lisa; Thompson, Nicola D.

2015-01-01

Background Drug diversion by health care personnel poses a risk for serious patient harm. Public health identified 2 patients diagnosed with acute hepatitis C virus (HCV) infection who shared a common link with a hospital. Further investigation implicated a drug-diverting, HCV-infected surgical technician who was subsequently employed at an ambulatory surgical center. Methods Patients at the 2 facilities were offered testing for HCV infection if they were potentially exposed. Serum from the surgical technician and patients testing positive for HCV but without evidence of infection before their surgical procedure was further tested to determine HCV genotype and quasi-species sequences. Parenteral medication handling practices at the 2 facilities were evaluated. Results The 2 facilities notified 5970 patients of their possible exposure to HCV, 88% of whom were tested and had results reported to the state public health departments. Eighteen patients had HCV highly related to the surgical technician’s virus. The surgical technician gained unauthorized access to fentanyl owing to limitations in procedures for securing controlled substances. Conclusions Public health surveillance identified an outbreak of HCV infection due to an infected health care provider engaged in diversion of injectable narcotics. The investigation highlights the value of public health surveillance in identifying HCV outbreaks and uncovering a method of drug diversion and its impacts on patients. PMID:25442395

Visual compatibility of defibrotide with selected drugs during simulated Y-site administration.

PubMed

Correard, Florian; Savry, Amandine; Gauthier-Villano, Laurence; Pisano, Pascale; Pourroy, Bertrand

2014-08-01

The visual compatibility of a solution of defibrotide (the only drug recommended for treatment and prophylaxis of hepatic venoocclusive disease) with solutions of various drugs commonly administered in bone marrow transplant procedures was studied. Solutions of 43 drug products in concentrations typically used in clinical practice were evaluated in 1:1 mixtures with defibrotide solution in glass tubes kept at room temperature. The evaluated products included antiinfectious, corticoid, sedative, analgesic, and cardiovascular agents widely used for hematopoietic stem cell transplantation and other marrow transplant procedures; in most cases, test solutions were prepared via dilution in or reconstitution with sterile water, 0.9% sodium chloride injection, or 5% dextrose injection. The mixtures were visually observed immediately after manual mixing and at specified time points (60, 150, and 240 minutes). Visual compatibility was defined as the absence of color change, haze, fibers, particles, gas generation, and precipitate formation. The effect of mixing order on visual compatibility was ascertained. Of the 43 tested drug solutions, 36 were found to be visually compatible with the defibrotide solution over the entire four-hour study period. Solutions of 7 drugs (amikacin, furosemide, midazolam, mycophenolate mofetil, nicardipine, tobramycin, and vancomycin) were visually incompatible with defibrotide solution. In some cases, evidence of incompatibility was observed intermittently or was dependent on mixing order. Defibrotide solution was found to be visually compatible with solutions of 36 i.v. products that are likely to be coadministered with the drug in a bone marrow transplant unit. Seven drug solutions were visually incompatible with defibrotide solution. Copyright © 2014 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

A biotin-drug extraction and acid dissociation (BEAD) procedure to eliminate matrix and drug interference in a protein complex anti-drug antibody (ADA) isotype specific assay.

PubMed

Niu, Hongmei; Klem, Thomas; Yang, Jinsong; Qiu, Yongchang; Pan, Luying

2017-07-01

Monitoring anti-drug antibody (ADA) responses in patients receiving protein therapeutics treatment is an important safety assessment for regulatory agencies, drug manufacturers, clinicians and patients. Recombinant human IGF-1/IGFBP-3 (rhIGF-1/rhIGFBP-3) is a 1:1 formulation of naturally occurring protein complex. The individual IGF-1 and IGFBP-3 proteins have multiple binding partners in serum matrix with high binding affinity to each other, which presents challenges in ADA assay development. We have developed a biotin-drug extraction with acid dissociation (BEAD) procedure followed by an electrochemiluminescence (ECL) direct assay to overcome matrix and drug interference. The method utilizes two step acid dissociation and excess biotin-drug to extract total ADA, which are further captured by soluble biotin-drug and detected in an ECL semi-homogeneous direct assay format. The pre-treatment method effectively eliminates interference by serum matrix and free drug, and enhances assay sensitivity. The assays passed acceptance criteria for all validation parameters, and have been used for clinical sample Ab testing. This method principle exemplifies a new approach for anti-isotype ADA assays, and could be an effective strategy for neutralizing antibody (NAb), pharmacokinetic (PK) and biomarker analysis in need of overcoming interference factors. Copyright © 2017 Elsevier B.V. All rights reserved.

49 CFR 40.383 - What procedures apply if you contest the issuance of a PIE?

Code of Federal Regulations, 2010 CFR

2010-10-01

... FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public Interest Exclusions § 40.383... you. (d) In cases where there are material factual issues in dispute, the Director or his or her...

49 CFR 40.365 - What is the Department's policy concerning starting a PIE proceeding?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public Interest Exclusions § 40.365... constitutes a conflict of interest under this part (e.g., a laboratory that derives a financial benefit from...

Development of postcompressional textural tests to evaluate the mechanical properties of medicated chewing gum tablets with high drug loadings.

PubMed

Al Hagbani, Turki; Nazzal, Sami

2018-02-01

Medicated chewing gum tablets (CGTs) represent a unique platform for drug delivery. Loading directly compressible gums with high concentrations of powdered medication, however, results in compacts with hybrid properties between a chewable gum and a brittle tablet. The aim of the present study was to develop textural tests that can identify the point at which CGTs begin to behave like a solid tablet upon drug incorporation. Curcumin (CUR) CGTs made with Health in gum were prepared with increasing CUR load from 0 to 100% and were characterized for their mechanical properties by a single-bite (knife) and a two-bite tests. From each test several parameters were extracted and correlated with drug loading. In the single-bite test, the change in the resistance of the compacts to plastic deformation was found to give a definitive guide on whether they behave as gums or tablets. A more in depth analysis of the impact of CUR loading on the chewability of the CGTs was provided by the two-bite test where CUR loading was found to have a nonlinear impact on the mechanical properties of compacts. An upper limit of 10% was found to yield compacts with gum-like properties, which were abolished at higher CUR loads. The textural test procedure outlined in this study are expected to assist those involved in the formulation of medicated gums for pharmaceutical applications in making an informed decision on the impact of drug loading on gum behavior before proceeding with clinical testing. There is a growing interest in utilizing medicated chewing gums for drug delivery, especially those made using directly compressible gum bases, such as Health in gum. Directly compressing a gum base with high amounts of solid drug powder, however, poses a challenge as it may result in compressed compacts with hybrid properties between a chewing gum and a hard tablet. Currently, official Pharmacopeias do not specify a testing procedure for the estimation of the mechanical and textural properties of chewing gum tablets. To fill in the knowledge gap, we demonstrated in the present study how complementing a single-bite (knife) test with a modified two-bite test could be used to discriminate between chewing gums and hard tablets that were prepared by directly compressing Health in gum base with increasing concentration of curcumin powder in the blend. By utilizing these two tests, it was possible to identify clear demarcations between conventional tablets and chewing gums. In this study, we found that a 10% load by weight is the upper limit for curcumin loading in a binary blend with Health in gum to maintain the mastication properties of the compacts, which become brittle tablets at 30% load. © 2017 Wiley Periodicals, Inc.

49 CFR 40.183 - What information do laboratories report to MROs regarding split specimen results?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false What information do laboratories report to MROs regarding split specimen results? 40.183 Section 40.183 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Split Specimen Tests § 40.183 What information do laboratories...

Stimulus properties of nicotine, amphetamine, and chlordiazepoxide as positive features in a pavlovian appetitive discrimination task in rats.

PubMed

Palmatier, Matthew I; Wilkinson, Jamie L; Metschke, Dawn M; Bevins, Rick A

2005-04-01

Recent experiments from our laboratory have demonstrated that drug states can signal when environmental cues will be followed by rewarding outcomes (ie Pavlovian conditioning). However, little is known about the generality of this approach and whether it can be used for studying the pharmacological properties of drug states. Accordingly, the present experiments tested the pharmacological specificity of nicotine (0.4 mg/kg), amphetamine (1 mg/kg), and chlordiazepoxide (CDP, 5 mg/kg) in this Pavlovian drug discrimination procedure. Following drug administration, presentation of a conditional stimulus (CS) was followed by brief access to sucrose. When saline was administered, the same CS was presented but sucrose was withheld. In substitution tests, rats in each condition received varying doses of all training drugs and caffeine. Anticipatory food seeking developed during the CS on drug sessions but not on saline sessions for all drug features (ie drug state-specific conditional response (CR)). In generalization tests, this CR decreased as a function of decreases in the training dose. Median effective doses (ED50s) were calculated for nicotine (0.054 mg/kg), amphetamine (0.26 mg/kg), and CDP (2.48 mg/kg). No compound tested substituted for the CDP training drug. Partial substitution was evident between nicotine and amphetamine; CDP did not substitute for either of these drug features. Caffeine fully substituted for nicotine (ED50 = 15.45 mg/kg) and amphetamine (ED50 = 3.70 mg/kg), but not for CDP. These results are consistent with the hypothesis that drug states can occasion appetitive Pavlovian CRs in a pharmacologically specific manner.

Process analytical technology to understand the disintegration behavior of alendronate sodium tablets.

PubMed

Xu, Xiaoming; Gupta, Abhay; Sayeed, Vilayat A; Khan, Mansoor A

2013-05-01

Various adverse events including esophagus irritations have been reported with the use of alendronate tablets, likely attributed to the rapid tablet disintegration in the mouth or esophagus. Accordingly, the disintegration of six alendronate tablet drug products was studied using a newly developed testing device equipped with in-line sensors, in addition to the official compendial procedure for measuring the disintegration time. The in-line sensors were used to monitor the particle count and solution pH change to assess the onset and duration of disintegration. A relatively large variation was observed in the disintegration time of the tested drug products using the compendial method. The data collected using the in-line sensors suggested that all tested drug products exhibited almost instantaneous onset of disintegration, under 2 s, and a sharp drop in solution pH. The drop in pH was slower for tablets with slower disintegration. The in-house prepared alendronate test tablets also showed similar trends suggesting rapid solubilization of the drug contributed to the fast tablet disintegration. This research highlights the usefulness of the newly developed in-line analytical method in combination with the compendial method in providing a better understanding of the disintegration and the accompanying drug solubilization processes for fast disintegrating tablet drug products. Copyright © 2013 Wiley Periodicals, Inc.

A Method of Retrospective Computerized System Validation for Drug Manufacturing Software Considering Modifications

NASA Astrophysics Data System (ADS)

Takahashi, Masakazu; Fukue, Yoshinori

This paper proposes a Retrospective Computerized System Validation (RCSV) method for Drug Manufacturing Software (DMSW) that relates to drug production considering software modification. Because DMSW that is used for quality management and facility control affects big impact to quality of drugs, regulatory agency required proofs of adequacy for DMSW's functions and performance based on developed documents and test results. Especially, the work that explains adequacy for previously developed DMSW based on existing documents and operational records is called RCSV. When modifying RCSV conducted DMSW, it was difficult to secure consistency between developed documents and test results for modified DMSW parts and existing documents and operational records for non-modified DMSW parts. This made conducting RCSV difficult. In this paper, we proposed (a) definition of documents architecture, (b) definition of descriptive items and levels in the documents, (c) management of design information using database, (d) exhaustive testing, and (e) integrated RCSV procedure. As a result, we could conduct adequate RCSV securing consistency.

A World Allergy Organization International Survey on Diagnostic Procedures and Therapies in Drug Allergy/Hypersensitivity

PubMed Central

Mirakian, Rita; Castells, Mariana; Pichler, Werner; Romano, Antonino; Bonadonna, Patrizia; Diana, Deleanu; Kowalski, Marek; Yanez, Anahi; Lleonart, Ramon; Sanchez-Borges, Mario; Demoly, Pascal

2011-01-01

Objective To study the diagnostic and treatment modalities used in drug allergy/hypersensitivity among members of the World Allergy Organization (WAO). Methods A questionnaire comprising 39 questions was circulated electronically to member societies, associate member societies, and regional and affiliate organizations of WAO between June 29, 2009, and August 9, 2009. Results Eighty-two responses were received. Skin testing was used by 74.7%, with only 71.4% having access to penicillin skin test reagents. In vitro–specific IgE tests were used by 67.4%, and basophil activation test was used by 54.4%. Lymphocyte transformation tests were used by 36.8% and patch tests by 54.7%. Drug provocation tests were used by 68.4%, the most common indication being to exclude hypersensitivity where history/symptoms were not suggestive of drug hypersensitivity/allergy (76.9%). Rapid desensitization for chemotherapy, antibiotics, or biologic agents was used by 69.6%. Systemic corticosteroid was used in the treatment of Stevens–Johnson syndrome by 72.3%, and high-dose intravenous immunoglobulins in toxic epidermal necrolysis by 50.8%. Human leukocyte antigen screening before prescription of abacavir was used by 92.9% and before prescription of carbamazepine by 21.4%. Conclusions Results of this survey form a useful framework for developing educational and training needs and for improving access to drug allergy diagnostic and treatment modalities across WAO member societies. PMID:23268453

78 FR 46955 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

...] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014 AGENCY: Food and Drug... payment procedures for fiscal year (FY) 2014 animal drug user fees. The Federal Food, Drug, and Cosmetic... submissions. This notice establishes the fee rates for FY 2014. FOR FURTHER INFORMATION CONTACT: Visit FDA's...

Prolonged withdrawal following cocaine self-administration increases resistance to punishment in a cocaine binge.

PubMed

Gancarz-Kausch, Amy M; Adank, Danielle N; Dietz, David M

2014-11-03

Drug addiction is characterized by compulsive drug-taking behaviors and a high propensity to relapse following drug cessation. Drug craving and seeking can increase during a period of abstinence, but this phenomenon is not observed in drug-induced reinstatement models. To investigate the effect of withdrawal on cocaine relapse, rats were exposed to extended-access cocaine self-administration and subjected to either 1 or 30 d of withdrawal. When tested during 12 h unlimited access to cocaine (binge), the duration of the withdrawal did not influence cocaine intake. However, using a histamine punishment procedure that greatly suppresses drug-taking behavior, we demonstrate that longer periods of abstinence from cocaine induce a greater persistence in responding for drug in the face of negative consequences.

A Memory Retrieval-Extinction Procedure to Prevent Drug Craving and Relapse

PubMed Central

Xue, Yan-Xue; Luo, Yi-Xiao; Wu, Ping; Shi, Hai-Shui; Xue, Li-Fen; Chen, Chen; Zhu, Wei-Li; Ding, Zeng-Bo; Bao, Yan-ping; Shi, Jie; Epstein, David H.; Shaham, Yavin; Lu, Lin

2013-01-01

Drug use and relapse involve learned associations between drug-associated environmental cues and drug effects. Extinction procedures in the clinic can suppress conditioned responses to drug cues, but the extinguished responses typically reemerge after exposure to the drug itself (reinstatement), the drug-associated environment (renewal), or the passage of time (spontaneous recovery). We describe a memory retrieval-extinction procedure that decreases conditioned drug effects and drug seeking in rat models of relapse, and drug craving in abstinent heroin addicts. In rats, daily retrieval of drug-associated memories 10 minutes or 1 hour but not 6 hours before extinction sessions attenuated drug-induced reinstatement, spontaneous recovery, and renewal of conditioned drug effects and drug seeking. In heroin addicts, retrieval of drug-associated memories 10 minutes before extinction sessions attenuated cue-induced heroin craving 1, 30, and 180 days later. The memory retrieval-extinction procedure is a promising nonpharmacological method for decreasing drug craving and relapse during abstinence. PMID:22499948

Drug and alcohol-impaired driving among electronic music dance event attendees

PubMed Central

Furr-Holden, Debra; Voas, Robert B.; Kelley-Baker, Tara; Miller, Brenda

2011-01-01

Background Drug-impaired driving has received increased attention resulting from development of rapid drug-screening procedures used by police and state laws establishing per se limits for drug levels in drivers. Venues that host electronic music dance events (EMDEs) provide a unique opportunity to assess drug-impaired driving among a high proportion of young adult drug users. EMDEs are late-night dance parties marked by a substantial number of young adult attendees and elevated drug involvement. No studies to date have examined drug-impaired driving in a natural environment with active drug and alcohol users. Methods Six EMDEs were sampled in San Diego, California, and Baltimore, Maryland. A random sample of approximately 40 attendees per event were administered surveys about alcohol and other drug (AOD) use and driving status, given breath tests for alcohol, and asked to provide oral fluid samples to test for illicit drug use upon entering and exiting the events. Results Driving status reduced the level of alcohol use (including abstaining) but the impact on drug-taking was not significant. However, 62% of individuals who reported their intention to drive away from the events were positive for drugs or alcohol upon leaving. This suggests that these events and settings are appropriate ones for developing interventions for reducing risks for young adults. PMID:16675160

Drug and alcohol-impaired driving among electronic music dance event attendees.

PubMed

Furr-Holden, Debra; Voas, Robert B; Kelley-Baker, Tara; Miller, Brenda

2006-10-15

Drug-impaired driving has received increased attention resulting from development of rapid drug-screening procedures used by police and state laws establishing per se limits for drug levels in drivers. Venues that host electronic music dance events (EMDEs) provide a unique opportunity to assess drug-impaired driving among a high proportion of young adult drug users. EMDEs are late-night dance parties marked by a substantial number of young adult attendees and elevated drug involvement. No studies to date have examined drug-impaired driving in a natural environment with active drug and alcohol users. Six EMDEs were sampled in San Diego, California, and Baltimore, Maryland. A random sample of approximately 40 attendees per event were administered surveys about alcohol and other drug (AOD) use and driving status, given breath tests for alcohol, and asked to provide oral fluid samples to test for illicit drug use upon entering and exiting the events. Driving status reduced the level of alcohol use (including abstaining) but the impact on drug-taking was not significant. However, 62% of individuals who reported their intention to drive away from the events were positive for drugs or alcohol upon leaving. This suggests that these events and settings are appropriate ones for developing interventions for reducing risks for young adults.

Predicting hydration free energies of amphetamine-type stimulants with a customized molecular model

NASA Astrophysics Data System (ADS)

Li, Jipeng; Fu, Jia; Huang, Xing; Lu, Diannan; Wu, Jianzhong

2016-09-01

Amphetamine-type stimulants (ATS) are a group of incitation and psychedelic drugs affecting the central nervous system. Physicochemical data for these compounds are essential for understanding the stimulating mechanism, for assessing their environmental impacts, and for developing new drug detection methods. However, experimental data are scarce due to tight regulation of such illicit drugs, yet conventional methods to estimate their properties are often unreliable. Here we introduce a tailor-made multiscale procedure for predicting the hydration free energies and the solvation structures of ATS molecules by a combination of first principles calculations and the classical density functional theory. We demonstrate that the multiscale procedure performs well for a training set with similar molecular characteristics and yields good agreement with a testing set not used in the training. The theoretical predictions serve as a benchmark for the missing experimental data and, importantly, provide microscopic insights into manipulating the hydrophobicity of ATS compounds by chemical modifications.

Er:YAG laser-induced changes in skin in vivo and transdermal drug delivery

NASA Astrophysics Data System (ADS)

Flock, Stephen T.; Stern, Tom; Lehman, Paul; Dinehart, Scott; Franz, Tom; Liu, George; Stern, Scott J.

1997-05-01

It has been shown that laser ablation of stratum corneum, in vitro, can result in an increased uptake of topically applied pharmaceuticals. We have performed measurements of drug permeation, using an in vitro model of human skin, that involves a portable Er:YAG laser used to ablate the stratum corneum. For the first time, this method of drug administration was tested in vivo in human volunteers, whereby a hydrocortisone blanching assay was used to assess the efficiency of the procedure. The results show that this is a safe and efficient way to ablate stratum corneum for the purpose of enhanced transcutaneous drug administration.

Desensitization in delayed drug hypersensitivity reactions -- an EAACI position paper of the Drug Allergy Interest Group.

PubMed

Scherer, K; Brockow, K; Aberer, W; Gooi, J H C; Demoly, P; Romano, A; Schnyder, B; Whitaker, P; Cernadas, J S R; Bircher, A J

2013-07-01

Drug hypersensitivity may deprive patients of drug therapy, and occasionally no effective alternative treatment is available. Successful desensitization has been well documented in delayed drug hypersensitivity reactions. In certain situations, such as sulfonamide hypersensitivity in HIV-positive patients or hypersensitivity to antibiotics in patients with cystic fibrosis, published success rates reach 80%, and this procedure appears helpful for the patient management. A state of clinical tolerance may be achieved by the administration of increasing doses of the previously offending drug. However, in most cases, a pre-existent sensitization has not been proven by positive skin tests. Successful re-administration may have occurred in nonsensitized patients. A better understanding of the underlying mechanisms of desensitization is needed. Currently, desensitization in delayed hypersensitivity reactions is restricted to mild, uncomplicated exanthems and fixed drug eruptions. The published success rates vary depending on clinical manifestations, drugs, and applied protocols. Slower protocols tend to be more effective than rush protocols; however, underreporting of unsuccessful procedures is very probable. The decision to desensitize a patient must always be made on an individual basis, balancing risks and benefits. This paper reviews the literature and presents the expert experience of the Drug Hypersensitivity Interest Group of the European Academy of Allergy and Clinical Immunology. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

49 CFR 40.371 - On what information does an initiating official rely in deciding whether to start a PIE proceeding?

Code of Federal Regulations, 2012 CFR

2012-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public... affect the initiating official's determination about whether it is necessary to send a correction notice...

49 CFR 40.371 - On what information does an initiating official rely in deciding whether to start a PIE proceeding?

Code of Federal Regulations, 2011 CFR

2011-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public... affect the initiating official's determination about whether it is necessary to send a correction notice...

49 CFR 40.371 - On what information does an initiating official rely in deciding whether to start a PIE proceeding?

Code of Federal Regulations, 2014 CFR

2014-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public... affect the initiating official's determination about whether it is necessary to send a correction notice...

49 CFR 40.371 - On what information does an initiating official rely in deciding whether to start a PIE proceeding?

Code of Federal Regulations, 2013 CFR

2013-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public... affect the initiating official's determination about whether it is necessary to send a correction notice...

49 CFR 40.371 - On what information does an initiating official rely in deciding whether to start a PIE proceeding?

Code of Federal Regulations, 2010 CFR

2010-10-01

... Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public... affect the initiating official's determination about whether it is necessary to send a correction notice...

77 FR 60318 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: 6-acetylmorphine (6-AM...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... final rule to harmonize with many aspects of the revised Department of Health and Human Services (HHS... (ODAPC). After consulting with ODAPC, the MRO would make a verified result determination, keeping in mind...

49 CFR 40.160 - What does the MRO do when a valid test result cannot be produced and a negative result is required?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What does the MRO do when a valid test result cannot be produced and a negative result is required? 40.160 Section 40.160 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification...

49 CFR 40.153 - How does the MRO notify employees of their right to a test of the split specimen?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false How does the MRO notify employees of their right to a test of the split specimen? 40.153 Section 40.153 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.153 Ho...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

Power of Orbitrap-based LC-high resolution-MS/MS for comprehensive drug testing in urine with or without conjugate cleavage or using dried urine spots after on-spot cleavage in comparison to established LC-MSn or GC-MS procedures.

PubMed

Michely, Julian A; Meyer, Markus R; Maurer, Hans H

2018-01-01

Reliable, sensitive, and comprehensive urine screening procedures by gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS) with low or high resolution (HR) are of high importance for drug testing, adherence monitoring, or detection of toxic compounds. Besides conventional urine sampling, dried urine spots are of increasing interest. In the present study, the power of LC-HR-MS/MS was investigated for comprehensive drug testing in urine with or without conjugate cleavage or using dried urine spots after on-spot cleavage in comparison to established LC-MS n or GC-MS procedures. Authentic human urine samples (n = 103) were split in 4 parts. One aliquot was prepared by precipitation (UP), one by UP with conjugate cleavage (UglucP), one spot on filter paper cards and prepared by on-spot cleavage followed by liquid extraction (DUSglucE), and one worked-up by acid hydrolysis, liquid-liquid extraction, and acetylation for GC-MS analysis. The 3 series of LC-HR-MS/MS results were compared among themselves, to corresponding published LC-MS n data, and to screening results obtained by conventional GC-MS. The reference libraries used for the 3 techniques contained over 4500 spectra of parent compounds and their metabolites. The number of all detected hits (770 drug intakes) was set to 100%. The LC-HR-MS/MS approach detected 80% of the hits after UP, 89% after UglucP, and 77% after DUSglucE, which meant over one-third more hits in comparison to the corresponding published LC-MS n results with ≤49% detected hits. The GC-MS approach identified 56% of all detected hits. In conclusion, LC-HR-MS/MS provided the best screening results after conjugate cleavage and precipitation. Copyright © 2017 John Wiley & Sons, Ltd.

21 CFR 310.502 - Certain drugs accorded new drug status through rulemaking procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for human use. (10) Parenteral drug products in plastic containers. (11) Sterilization of drugs by... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Certain drugs accorded new drug status through rulemaking procedures. 310.502 Section 310.502 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 310.502 - Certain drugs accorded new drug status through rulemaking procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... for human use. (10) Parenteral drug products in plastic containers. (11) Sterilization of drugs by... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Certain drugs accorded new drug status through rulemaking procedures. 310.502 Section 310.502 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 310.502 - Certain drugs accorded new drug status through rulemaking procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... for human use. (10) Parenteral drug products in plastic containers. (11) Sterilization of drugs by... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Certain drugs accorded new drug status through rulemaking procedures. 310.502 Section 310.502 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 310.502 - Certain drugs accorded new drug status through rulemaking procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... for human use. (10) Parenteral drug products in plastic containers. (11) Sterilization of drugs by... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Certain drugs accorded new drug status through rulemaking procedures. 310.502 Section 310.502 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

21 CFR 310.502 - Certain drugs accorded new drug status through rulemaking procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... for human use. (10) Parenteral drug products in plastic containers. (11) Sterilization of drugs by... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Certain drugs accorded new drug status through rulemaking procedures. 310.502 Section 310.502 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

75 FR 26183 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

... Omnibus Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 45101 et seq.) and the Department of Transportation Act (49 U.S.C. 322). This proposed rule is a non... follows: Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 45101 et seq. 2. In Appendix G to...

Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

NASA Astrophysics Data System (ADS)

Elliott, Kevin C.; Volz, David C.

2012-01-01

Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

49 CFR 40.169 - Where is other information concerning the role of MROs and the verification process found in this...

Code of Federal Regulations, 2010 CFR

2010-10-01

... of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING...—Relationship with laboratories; avoidance of conflicts of interest. § 40.105—Notification of discrepancies in...

The interpretation of hair analysis for drugs and drug metabolites.

PubMed

Cuypers, Eva; Flanagan, Robert J

2018-02-01

Head hair analysis for drugs and drug metabolites has been used widely with the aim of detecting exposure in the weeks or months prior to sample collection. However, inappropriate interpretation of results has likely led to serious miscarriages of justice, especially in child custody cases. The aim of this review is to assess critically what can, and perhaps more importantly, what cannot be claimed as regards the interpretation of hair test results in a given set of circumstances in order to inform future testing. We searched the PubMed database for papers published 2010-2016 using the terms "hair" and "drug" and "decontamination", the terms "hair" and "drug" and "contamination", the terms "hair" and "drug-facilitated crime", the terms "hair" and "ethyl glucuronide", and the terms "hair", "drug testing" and "analysis". Study of the reference lists of the 46 relevant papers identified 25 further relevant citations, giving a total of 71 citations. Hair samples: Drugs, drug metabolites and/or decomposition products may arise not only from deliberate drug administration, but also via deposition from a contaminated atmosphere if drug(s) have been smoked or otherwise vaporized in a confined area, transfer from contaminated surfaces via food/fingers, etc., and transfer from sweat and other secretions after a single large exposure, which could include anesthesia. Excretion in sweat of endogenous analytes such as γ-hydroxybutyric acid is a potential confounder if its use is to be investigated. Cosmetic procedures such as bleaching or heat treatment of hair may remove analytes prior to sample collection. Hair color and texture, the area of the head the sample is taken from, the growth rate of individual hairs, and how the sample has been stored, may also affect the interpretation of results. Toxicological analysis: Immunoassay results alone do not provide reliable evidence on which to base judicial decisions. Gas or liquid chromatography with mass spectrometric detection (GC- or LC-MS), if used with due caution, can give accurate analyte identification and high sensitivity, but many problems remain. Firstly, it is not possible to prepare assay calibrators or quality control material except by soaking "blank" hair in solutions of appropriate analytes, drying, and then subjecting the dried material to an analysis. The fact that solvents can be used to add analytes to hair points to the fact that analytes can arrive not only on, but also in hair from exogenous sources. A range of solvent-washing procedures have been advocated to "decontaminate" hair by removing adsorbed analytes, but these carry the risk of transporting adsorbed analytes into the medulla of the hair therefore confounding the whole procedure. This is especially true if segmental analysis is being undertaken in order to provide a "time course" of drug exposure. Proposed clinical applications of hair analysis: There have been a number of reports where drugs seemingly administered during the perpetration of a crime have been detected in head hair. However, detailed evaluation of these reports is difficult without full understanding of the possible effects of any "decontamination" procedures used and of other variables such as hair color or cosmetic hair treatment. Similarly, in child custody cases and where the aim is to demonstrate abstinence from drug or alcohol use, the issues of possible exogenous sources of analyte, and of the large variations in analyte concentrations reported in known users, continue to confound the interpretation of results in individual cases. Interpretation of results of head hair analysis must take into account all the available circumstantial and other evidence especially as regards the methodology employed and the possibility of surface contamination of the hair prior to collection.

Organotypic cultures as tools for testing neuroactive drugs - link between in-vitro and in-vivo experiments.

PubMed

Drexler, B; Hentschke, H; Antkowiak, B; Grasshoff, C

2010-01-01

The development of neuroactive drugs is a time consuming procedure. Candidate drugs must be run through a battery of tests, including receptor studies and behavioural tests on animals. As a rule, numerous substances with promising properties as assessed in receptor studies must be eliminated from the development pipeline in advanced test phases because of unforeseen problems like intolerable side-effects or unsatisfactory performance in the whole organism. Clearly, test systems of intermediate complexity would alleviate this inefficiency. In this review, we propose cultured organotypic brain slices as model systems that could bridge the 'interpolation gap' between receptors and the brain, with a focus on the development of new general anaesthetics with lesser side effects. General anaesthesia is based on the modulation of neurotransmitter receptors and other conductances located on neurons in diverse brain regions, including cerebral cortex and spinal cord. It is well known that different components of general anaesthesia, e.g. hypnosis and immobility, are produced by the depression of neuronal activity in distinct brain regions. The ventral horn of the spinal cord is an important structure for the induction of immobility. Thus, the potentially immobilizing effects of a newly designed drug can be estimated from its depressant effect on neuronal network activity in cultured spinal slices. A drug's sedative and hypnotic potential can be examined in cortical cultures. Combined with genetically engineered mice, this approach can point to receptor subtypes most relevant to the drug's intended net effect and in return can help in the design of more selective drugs. In conclusion, the use of organotypic cultures permits predictions of neuroactive properties of newly designed drugs on an intermediate level, and should therefore open up avenues for a more creative and economic drug development process.

Spiral Salmonella assay: validation against the standard pour-plate assay.

PubMed

Diehl, M; Fort, F

1996-01-01

The spiral Ames assay, an automated approach to bacterial mutagenicity testing which simplifies the test procedure and reduces the amount of drug required to generate mutagenic dose-response information, has been evaluated and validated for routine screening. The spiral plater delivers the Salmonella bacteria, exogenous metabolic activation system and drug to the surface of a rotating agar plate one on top of another in such a way that a uniform density of bacteria is exposed to a logarithmically decreasing volume of drug. Following an incubation of 48 hr at 37 degrees C, the plates are scanned by a laser counter, and the data are subjected to a computerized analysis. Petri plates of 15 cm diameter were used to provide a concentration range of about 250-fold per plate. The Salmonella were concentrated 20-fold to increase sensitivity. Thirty-eight compounds from a variety of chemical classes, including both pharmaceuticals and known mutagens of moderate to strong potency, were tested in both the spiral and the standard pour-plate assays. There was overall test agreement on positive or negative results for 82% of the compounds tested. When only the results from strains TA98 plus TA100 were considered, the agreement was 87%. When positive results were obtained, the fold increase over vehicle control was on average twice as great for the spiral assay compared to the pour-plate assay. It was concluded that the two assay procedures generally provided comparable results, with the spiral assay being somewhat more sensitive in terms of dose-response than the pour-plate assay.

Environmental and biological monitoring of platinum-containing drugs in two hospital pharmacies using positive air pressure isolators.

PubMed

Kopp, Bettina; Crauste-Manciet, Sylvie; Guibert, Agnès; Mourier, Wilhelmine; Guerrault-Moro, Marie-Noelle; Ferrari, Sylvie; Jomier, Jean-Yves; Brossard, Denis; Schierl, Rudolf

2013-04-01

Environmental and biological monitoring of platinum containing drugs was implemented in two French hospital pharmacies using positive air pressure isolators and having similar working procedures when preparing antineoplastic drugs. Wipe sampling of surfaces, gloves, and vials was performed in the preparation room and in storage areas. All employees involved in the preparation of antineoplastic drugs were tested for urinary platinum on Monday before work and Friday after shift. Only traces of platinum were detected on surfaces in the preparation room outside the isolators (less than 1.61 pg cm(-2)). However, in one center, significant contamination was found in the storage area of the drug vials, which can most likely be linked to the rupture of a platinum vial and due to inefficient cleaning procedures. Surfaces inside the isolators were found to be contaminated (maximum: 198.4 pg cm(-2)). A higher level of contamination was detected in one pharmacy and could be explained by the lack of overgloving with regular changes during the preparation process. Nitrile gloves used during drug handling outside the isolator showed the highest platinum concentration (maximum: 5.86 ng per pair). With regards to platinum urine concentration, no significant difference was found between exposed and unexposed pharmacy personnel. Isolator technology combined with individual protective measures seems to be efficient to protect workers from occupational exposure to antineoplastic drugs, whereas specific individual protective procedures implemented were focussing on the risk of handling vials outside the isolator (e.g. high frequency of glove changing). Moreover, overgloving inside the isolator would contribute to substantially decrease inner surface contamination and should be recommended in order to limit the transfer of chemical contamination to the end products.

VSU Campus Alcohol and Drug Policies and Procedures. Revised 1990. Program Design and Questionnaire.

ERIC Educational Resources Information Center

Virginia State Univ., Petersburg.

This document comprises the Virginia State University (VSU) Campus Alcohol and Drug Policies and Procedures booklet; a program design for a VSU drug education, treatment, and prevention program; and a drug and alcohol student survey. The booklet covering policies and procedures contains: a message from the president; a policy statement; a review…

21 CFR 111.353 - What are the requirements under this subpart K for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the requirements under this subpart K for written procedures? 111.353 Section 111.353 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... K for written procedures? You must establish and follow written procedures for manufacturing...

21 CFR 111.353 - What are the requirements under this subpart K for written procedures?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What are the requirements under this subpart K for written procedures? 111.353 Section 111.353 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... K for written procedures? You must establish and follow written procedures for manufacturing...

Pavlovian Discriminative Stimulus Effects of Methamphetamine in Male Japanese quail (Coturnix japonica)

PubMed Central

Bolin, B. Levi; Singleton, Destiny L.; Akins, Chana K.

2014-01-01

Pavlovian drug discrimination (DD) procedures demonstrate that interoceptive drug stimuli may come to control behavior by informing the status of conditional relationships between stimuli and outcomes. This technique may provide insight into processes that contribute to drug-seeking, relapse, and other maladaptive behaviors associated with drug abuse. The purpose of the current research was to establish a model of Pavlovian DD in male Japanese quail. A Pavlovian conditioning procedure was used such that 3.0 mg/kg methamphetamine served as a feature positive stimulus for brief periods of visual access to a female quail and approach behavior was measured. After acquisition training, generalization tests were conducted with cocaine, nicotine, and haloperidol under extinction conditions. SCH 23390 was used to investigate the involvement of the dopamine D1 receptor subtype in the methamphetamine discriminative stimulus. Results showed that cocaine fully substituted for methamphetamine but nicotine only partially substituted for methamphetamine in quail. Haloperidol dose-dependently decreased approach behavior. Pretreatment with SCH 23390 modestly attenuated the methamphetamine discrimination suggesting that the D1 receptor subtype may be involved in the discriminative stimulus effects of methamphetamine. The findings are discussed in relation to drug abuse and associated negative health consequences. PMID:24965811

49 CFR 40.401 - How does the Department notify employers and the public about a PIE?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public Interest Exclusions § 40.401.... (b) When the Director issues a PIE, he or she adds to the List the name and address of the service...

Effects of secobarbital and d-amphetamine on tracking performance during angular acceleration.

DOT National Transportation Integrated Search

1973-12-01

Thirty young men were randomly assigned in equal numbers to one of the following groups: placebo (lactose), secobarbital (100 mg), or d-amphetamine (10 mg). The drugs or placebo were administered in capsules in a double-blind procedure. Tests were sc...

49 CFR 655.52 - Substance abuse professional (SAP).

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false Substance abuse professional (SAP). 655.52 Section 655.52 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT... OPERATIONS Drug and Alcohol Testing Procedures § 655.52 Substance abuse professional (SAP). The SAP must...

49 CFR 655.52 - Substance abuse professional (SAP).

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Substance abuse professional (SAP). 655.52 Section 655.52 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT... OPERATIONS Drug and Alcohol Testing Procedures § 655.52 Substance abuse professional (SAP). The SAP must...

49 CFR 655.52 - Substance abuse professional (SAP).

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 7 2013-10-01 2013-10-01 false Substance abuse professional (SAP). 655.52 Section 655.52 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT... OPERATIONS Drug and Alcohol Testing Procedures § 655.52 Substance abuse professional (SAP). The SAP must...

49 CFR 655.52 - Substance abuse professional (SAP).

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false Substance abuse professional (SAP). 655.52 Section 655.52 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT... OPERATIONS Drug and Alcohol Testing Procedures § 655.52 Substance abuse professional (SAP). The SAP must...

49 CFR 655.52 - Substance abuse professional (SAP).

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false Substance abuse professional (SAP). 655.52 Section 655.52 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT... OPERATIONS Drug and Alcohol Testing Procedures § 655.52 Substance abuse professional (SAP). The SAP must...

10 CFR 707.15 - Collective bargaining.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Collective bargaining. 707.15 Section 707.15 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.15 Collective bargaining. When establishing drug testing programs, contractors who are parties to collective bargaining...

10 CFR 707.15 - Collective bargaining.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Collective bargaining. 707.15 Section 707.15 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.15 Collective bargaining. When establishing drug testing programs, contractors who are parties to collective bargaining...

10 CFR 707.15 - Collective bargaining.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Collective bargaining. 707.15 Section 707.15 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.15 Collective bargaining. When establishing drug testing programs, contractors who are parties to collective bargaining...

10 CFR 707.15 - Collective bargaining.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Collective bargaining. 707.15 Section 707.15 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.15 Collective bargaining. When establishing drug testing programs, contractors who are parties to collective bargaining...

10 CFR 707.15 - Collective bargaining.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Collective bargaining. 707.15 Section 707.15 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.15 Collective bargaining. When establishing drug testing programs, contractors who are parties to collective bargaining...

Accuracy of using Diagnosis Procedure Combination administrative claims data for estimating the amount of opioid consumption among cancer patients in Japan.

PubMed

Iwamoto, Momoko; Higashi, Takahiro; Miura, Hiroki; Kawaguchi, Takahiro; Tanaka, Shigeyuki; Yamashita, Itsuku; Yoshimoto, Tetsusuke; Yoshida, Shigeaki; Matoba, Motohiro

2015-11-01

The state of opioid consumption among cancer patients has never been comprehensively investigated in Japan. The Diagnosis Procedure Combination claims data may be used to measure and monitor opioid consumption among cancer patients, but the accuracy of using the Diagnosis Procedure Combination data for this purpose has never been tested. We aimed to ascertain the accuracy of using the Diagnosis Procedure Combination claims data for estimating total opioid analgesic consumption by cancer patients compared with electronic medical records at Aomori Prefectural Central Hospital. We calculated percent differences between estimates obtained from electronic medical records and Diagnosis Procedure Combination claims data by month and drug type (morphine, oxycodone, fentanyl, buprenorphine, codeine and tramadol) between 1 October 2012 and 30 September 2013, and further examined the causes of discrepancy by reviewing medical and administrative charts between April and July 2013. Percent differences varied by month for drug types with small prescription volumes, but less so for drugs with larger prescription volumes. Differences also tended to diminish when consumption was compared for a year instead of a month. Total percent difference between electronic medical records and Diagnosis Procedure Combination data during the study period was -0.1% (4721 mg per year per hospital), as electronic medical records as baseline. Half of the discrepancy was caused by errors in data entry. Our study showed that Diagnosis Procedure Combination claims data can be used to accurately estimate opioid consumption among a population of cancer patients, although the same conclusion cannot be made for individual estimates or when making estimates for a group of patients over a short period of time. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

78 FR 46958 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

...] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014 AGENCY: Food and Drug... and payment procedures for fiscal year (FY) 2014 generic new animal drug user fees. The Federal Food... for FY 2014. FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry...

49 CFR 40.185 - Through what methods and to whom must a laboratory report split specimen results?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false Through what methods and to whom must a laboratory report split specimen results? 40.185 Section 40.185 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Split Specimen Tests § 40.185 Through what methods and to whom...

Identifying types of drug intoxication : laboratory evaluation of a subject-examination procedure

DOT National Transportation Integrated Search

1985-05-01

The Los Angeles Police Department (LAPD) has developed a rating procedures for use in detecting drug-impaired drivers. The purpose of the rating procedures is to determine whether the driver is impaired and to identify the responsible drug class (e.g...

21 CFR 640.120 - Alternative procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Alternative procedures. 640.120 Section 640.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Alternative Procedures § 640.120...

21 CFR 640.120 - Alternative procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Alternative procedures. 640.120 Section 640.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Alternative Procedures § 640.120...

Animal models for testing anti-prion drugs.

PubMed

Fernández-Borges, Natalia; Elezgarai, Saioa R; Eraña, Hasier; Castilla, Joaquín

2013-01-01

Prion diseases belong to a group of fatal infectious diseases with no effective therapies available. Throughout the last 35 years, less than 50 different drugs have been tested in different experimental animal models without hopeful results. An important limitation when searching for new drugs is the existence of appropriate models of the disease. The three different possible origins of prion diseases require the existence of different animal models for testing anti-prion compounds. Wild type, over-expressing transgenic mice and other more sophisticated animal models have been used to evaluate a diversity of compounds which some of them were previously tested in different in vitro experimental models. The complexity of prion diseases will require more pre-screening studies, reliable sporadic (or spontaneous) animal models and accurate chemical modifications of the selected compounds before having an effective therapy against human prion diseases. This review is intended to put on display the more relevant animal models that have been used in the search of new antiprion therapies and describe some possible procedures when handling chemical compounds presumed to have anti-prion activity prior to testing them in animal models.

21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

Code of Federal Regulations, 2013 CFR

2013-04-01

... distribution of PET drug products? 212.90 Section 212.90 Food and Drugs FOOD AND DRUG ADMINISTRATION... distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from the PET drug...

21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

Code of Federal Regulations, 2011 CFR

2011-04-01

... distribution of PET drug products? 212.90 Section 212.90 Food and Drugs FOOD AND DRUG ADMINISTRATION... distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from the PET drug...

21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

Code of Federal Regulations, 2012 CFR

2012-04-01

... distribution of PET drug products? 212.90 Section 212.90 Food and Drugs FOOD AND DRUG ADMINISTRATION... distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from the PET drug...

21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

Code of Federal Regulations, 2014 CFR

2014-04-01

... distribution of PET drug products? 212.90 Section 212.90 Food and Drugs FOOD AND DRUG ADMINISTRATION... distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from the PET drug...

PHARMACOLOGIC TREATMENT OF HYPERALGESIA EXPERIMENTALLY INDUCED BY NUCLEUS PULPOSUS

PubMed Central

de Souza Grava, André Luiz; Ferrari, Luiz Fernando; Parada, Carlos Amílcar; Defino, Helton Luiz Aparecido

2015-01-01

Objective: To evaluate the effect of anti-inflammatory drugs (dexamethasone, indomethacin, atenolol and indomethacin plus atenolol) and analgesic drugs (morphine) on hyperalgesia experimentally induced by the nucleus pulposus (NP) in contact with the L5 dorsal root ganglion (DRG). Methods: Thirty male Wistar rats of weights ranging from 220 to 250 g were used in the study. Hyperalgesia was induced by means of a fragment of NP removed from the sacrococcygeal region that was placed in contact with the L5 dorsal root ganglion. The 30 animals were divided into experimental groups according to the drug used. The drugs were administered for two weeks after the surgical procedure to induce hyperalgesia. Mechanical and thermal hyperalgesia was evaluated using the paw pressure test, von Frey electronic test and Hargreaves test, over a seven-week period. Results: The greatest reduction of hyperalgesia was observed in the group of animals treated with morphine, followed by dexamethasone, indomethacin and atenolol. Reductions in hyperalgesia were observed after drug administration ceased, except for the group of animals treated with morphine, in which there was an increase in hyperalgesia after discontinuation of the treatment. Conclusion: Hyperalgesia induced by NP contact with the DRG can be reduced through administration of anti-inflammatory and analgesic drugs, but a greater reduction was observed with the administration of dexamethasone. PMID:27026966

Annual banned-substance review: analytical approaches in human sports drug testing.

PubMed

Thevis, Mario; Kuuranne, Tiia; Walpurgis, Katja; Geyer, Hans; Schänzer, Wilhelm

2016-01-01

The aim of improving anti-doping efforts is predicated on several different pillars, including, amongst others, optimized analytical methods. These commonly result from exploiting most recent developments in analytical instrumentation as well as research data on elite athletes' physiology in general, and pharmacology, metabolism, elimination, and downstream effects of prohibited substances and methods of doping, in particular. The need for frequent and adequate adaptations of sports drug testing procedures has been incessant, largely due to the uninterrupted emergence of new chemical entities but also due to the apparent use of established or even obsolete drugs for reasons other than therapeutic means, such as assumed beneficial effects on endurance, strength, and regeneration capacities. Continuing the series of annual banned-substance reviews, literature concerning human sports drug testing published between October 2014 and September 2015 is summarized and reviewed in reference to the content of the 2015 Prohibited List as issued by the World Anti-Doping Agency (WADA), with particular emphasis on analytical approaches and their contribution to enhanced doping controls. Copyright © 2016 John Wiley & Sons, Ltd.

Using Laboratory Chemicals to Imitate Illicit Drugs in a Forensic Chemistry Activity

ERIC Educational Resources Information Center

Hasan, Shawn; Bromfield-Lee, Deborah; Oliver-Hoyo, Maria T.; Cintron-Maldonado, Jose A.

2008-01-01

This forensic chemistry activity utilizes presumptive forensic testing procedures and laboratory chemicals that produce screening results similar to controlled substances. For obvious reasons, obtaining heavily regulated controlled substances to create an undergraduate student activity is not practical for most educational institutions. We were…

21 CFR 25.15 - General procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General procedures. 25.15 Section 25.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENVIRONMENTAL IMPACT CONSIDERATIONS Agency Actions Requiring Environmental Consideration § 25.15 General procedures. (a) All...

Food and Drug Administration regulation and evaluation of vaccines.

PubMed

Marshall, Valerie; Baylor, Norman W

2011-05-01

The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency.

Construction and characterization of a pure protein hydrogel for drug delivery application.

PubMed

Xu, Xu; Xu, ZhaoKang; Yang, XiaoFeng; He, YanHao; Lin, Rong

2017-02-01

Injectable hydrogels have a variety of applications, including regenerative medicine, tissue engineering and controlled drug delivery. In this paper, we reported on a pure protein hydrogel based on tetrameric recombinant proteins for the potential drug delivery application. This protein hydrogel was formed instantly by simply mixing two recombinant proteins (ULD-TIP1 and ULD-GGGWRESAI) through the specific protein-peptide interaction. The protein hydrogel was characterized by rheology and scanning electron microscopy (SEM). In vitro cytotoxicity test indicated that the developed protein hydrogel had no apparent cytotoxicity against L-929 cells and HCEC cells after 48h incubation. The formed protein hydrogels was gradually degraded after incubation in phosphate buffered solution (PBS, pH=7.4) for a period of 144h study, as indicated by in vitro degradation test. Encapsulation of model drug (sodium diclofenac; DIC) were achieved by simple mixing of drugs with hydrogelator and the entrapped drugs was almost completely released from hydrogels within 24h via a diffusion manner. As a conclusion, the simple and mild preparation procedure and good biocompatibility of protein hydrogel would render its good promising candidate for drug delivery applications. Copyright © 2016 Elsevier B.V. All rights reserved.

Comparative study of in vitro and in vivo drug effects on cell-mediated cytotoxicity.

PubMed Central

Borel, J F

1976-01-01

Cell-mediated cytolysis (CMC) was assayed in a system using spleen cells from mice (C57BL/6) sensitized with allogeneic tumour cells (DBA/2 mastocytoma P-815). Anti-inflammatory drugs, immunosuppressives, inhibitors of cell division and other agents were investigated for their capacity to inhibit CMC in three different ways. First, inhibition of CMC after in vitro addition of drug was observed with corticosteroids, some immunosuppressives and inhibitors of cell division. Secondly, suppression of CMC after a single drug administration to sensitized mice shortly before being killed was found with corticosteroids, several immunosuppressives and irradiation. Thirdly, prevention of development of CMC by repeated drug treatment (immunosuppressive schedule) was achieved with most immunosuppressives and cytostatic drugs. Non-steroidal anti-inflammatory drugs were inactive in these tests. Correlation of effects between the three procedures was very poor and it is suggested that various mechanisms may be involved in the different assays. PMID:824198

Drug-induced conditioned place preference and aversion in mice.

PubMed

Cunningham, Christopher L; Gremel, Christina M; Groblewski, Peter A

2006-01-01

This protocol describes the equipment and methods used to establish conditioned place preference (CPP) or aversion (CPA). Place conditioning is a form of Pavlovian conditioning routinely used to measure the rewarding or aversive motivational effects of objects or experiences (e.g., abused drugs). Here, we present a place conditioning procedure that has been used extensively to study the motivational effects of ethanol and other abused drugs in mice. This protocol involves three phases: (i) habituation (or a pretest), (ii) conditioning of an association between the drug and a tactile or visual stimulus and (iii) a test that offers a choice between the drug-associated cue and a neutral cue. If the drug has motivational significance, mice will spend significantly more time (CPP) or less time (CPA) in proximity to the drug-associated cue. Potential problems in the design and interpretation of place conditioning studies are discussed. A typical experiment lasts 2 weeks.

21 CFR 314.620 - Withdrawal procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.620 Withdrawal procedures. (a) Reasons to withdraw...

21 CFR 314.620 - Withdrawal procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.620 Withdrawal procedures. (a) Reasons to withdraw...

21 CFR 314.620 - Withdrawal procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.620 Withdrawal procedures. (a) Reasons to withdraw...

A Novel Technique to Follow Consequences of Exogenous Factors, Including Therapeutic Drugs, on Living Human Breast Epithelial Cells

DTIC Science & Technology

1999-07-01

and lipid vectors, are being tested. Concurrent with the development of procedures for live - cell imaging , we are examining the distribution of proteins...dimensional matrix. These studies have not yet begun. There are a number of procedures that must be developed and perfected in the live - cell imaging , as...components of the Wnt signaling pathway are too preliminary and require additional research prior to publication. (9) CONCLUSIONS Live cell imaging of

21 CFR 10.10 - Summaries of administrative practices and procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Summaries of administrative practices and procedures. 10.10 Section 10.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATIVE PRACTICES AND PROCEDURES General Provisions § 10.10 Summaries of...

Microbial sensor for drug susceptibility testing of Mycobacterium tuberculosis.

PubMed

Zhang, Z-T; Wang, D-B; Li, C-Y; Deng, J-Y; Zhang, J-B; Bi, L-J; Zhang, X-E

2018-01-01

Drug susceptibility testing (DST) of clinical isolates of Mycobacterium tuberculosis is critical in treating tuberculosis. We demonstrate the possibility of using a microbial sensor to perform DST of M. tuberculosis and shorten the time required for DST. The sensor is made of an oxygen electrode with M. tuberculosis cells attached to its surface. This sensor monitors the residual oxygen consumption of M. tuberculosis cells after treatment with anti-TB drugs with glycerine as a carbon source. In principle, after drug pretreatment for 4-5 days, the response differences between the sensors made of drug-sensitive isolates are distinguishable from the sensors made of drug-resistant isolates. The susceptibility of the M. tuberculosis H37Ra strain, its mutants and 35 clinical isolates to six common anti-TB drugs: rifampicin, isoniazid, streptomycin, ethambutol, levofloxacin and para-aminosalicylic acid were tested using the proposed method. The results agreed well with the gold standard method (LJ) and were determined in significantly less time. The whole procedure takes approximately 11 days and therefore has the potential to inform clinical decisions. To our knowledge, this is the first study that demonstrates the possible application of a dissolved oxygen electrode-based microbial sensor in M. tuberculosis drug resistance testing. This study used the microbial sensor to perform DST of M. tuberculosis and shorten the time required for DST. The overall detection result of the microbial sensor agreed well with that of the conventional LJ proportion method and takes less time than the existing phenotypic methods. In future studies, we will build an O 2 electrode array microbial sensor reactor to enable a high-throughput drug resistance analysis. © 2017 The Authors. Journal of Applied Microbiology published by John Wiley & Sons Ltd on behalf of The Society for Applied Microbiology.

21 CFR 530.24 - Procedure for announcing analytical methods for drug residue quantification.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals § 530.24 Procedure for announcing analytical methods for drug residue quantification. (a...

21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

Code of Federal Regulations, 2010 CFR

2010-04-01

... distribution of PET drug products? 212.90 Section 212.90 Food and Drugs FOOD AND DRUG ADMINISTRATION... control the distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from...

10 CFR 712.11 - General requirements for HRP certification.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false General requirements for HRP certification. 712.11 Section 712.11 Energy DEPARTMENT OF ENERGY HUMAN RELIABILITY PROGRAM Establishment of and Procedures for the..., “Drug-Free Federal Workplace Testing Implementation Program,” for DOE employees; (9) An initial alcohol...

10 CFR 712.11 - General requirements for HRP certification.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false General requirements for HRP certification. 712.11 Section 712.11 Energy DEPARTMENT OF ENERGY HUMAN RELIABILITY PROGRAM Establishment of and Procedures for the..., “Drug-Free Federal Workplace Testing Implementation Program,” for DOE employees; (9) An initial alcohol...

10 CFR 712.11 - General requirements for HRP certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false General requirements for HRP certification. 712.11 Section 712.11 Energy DEPARTMENT OF ENERGY HUMAN RELIABILITY PROGRAM Establishment of and Procedures for the..., “Drug-Free Federal Workplace Testing Implementation Program,” for DOE employees; (9) An initial alcohol...

49 CFR 40.73 - How is the collection process completed?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false How is the collection process completed? 40.73 Section 40.73 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Specimen Collections § 40.73 How is the collection process...

49 CFR 40.73 - How is the collection process completed?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false How is the collection process completed? 40.73 Section 40.73 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Specimen Collections § 40.73 How is the collection process...

49 CFR 40.73 - How is the collection process completed?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false How is the collection process completed? 40.73 Section 40.73 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Specimen Collections § 40.73 How is the collection process...

49 CFR 40.73 - How is the collection process completed?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false How is the collection process completed? 40.73 Section 40.73 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Specimen Collections § 40.73 How is the collection process...

49 CFR 40.289 - Are employers required to provide SAP and treatment services to employees?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false Are employers required to provide SAP and treatment services to employees? 40.289 Section 40.289 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse...

49 CFR 40.285 - When is a SAP evaluation required?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false When is a SAP evaluation required? 40.285 Section 40.285 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty Process...

49 CFR 40.289 - Are employers required to provide SAP and treatment services to employees?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false Are employers required to provide SAP and treatment services to employees? 40.289 Section 40.289 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse...

49 CFR 40.289 - Are employers required to provide SAP and treatment services to employees?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false Are employers required to provide SAP and treatment services to employees? 40.289 Section 40.289 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse...

49 CFR 40.289 - Are employers required to provide SAP and treatment services to employees?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false Are employers required to provide SAP and treatment services to employees? 40.289 Section 40.289 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse...

49 CFR 40.305 - How does the return-to-duty process conclude?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false How does the return-to-duty process conclude? 40.305 Section 40.305 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty...

49 CFR 40.305 - How does the return-to-duty process conclude?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false How does the return-to-duty process conclude? 40.305 Section 40.305 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty...

49 CFR 40.285 - When is a SAP evaluation required?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false When is a SAP evaluation required? 40.285 Section 40.285 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty Process...

49 CFR 40.311 - What are the requirements concerning SAP reports?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false What are the requirements concerning SAP reports? 40.311 Section 40.311 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty...

49 CFR 40.305 - How does the return-to-duty process conclude?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false How does the return-to-duty process conclude? 40.305 Section 40.305 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty...

49 CFR 40.289 - Are employers required to provide SAP and treatment services to employees?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Are employers required to provide SAP and treatment services to employees? 40.289 Section 40.289 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse...

49 CFR 40.285 - When is a SAP evaluation required?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false When is a SAP evaluation required? 40.285 Section 40.285 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty Process...

49 CFR 40.285 - When is a SAP evaluation required?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false When is a SAP evaluation required? 40.285 Section 40.285 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty Process...

49 CFR 40.285 - When is a SAP evaluation required?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false When is a SAP evaluation required? 40.285 Section 40.285 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty Process...

49 CFR 40.311 - What are the requirements concerning SAP reports?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false What are the requirements concerning SAP reports? 40.311 Section 40.311 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty...

49 CFR 40.305 - How does the return-to-duty process conclude?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false How does the return-to-duty process conclude? 40.305 Section 40.305 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty...

49 CFR 40.305 - How does the return-to-duty process conclude?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false How does the return-to-duty process conclude? 40.305 Section 40.305 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty...

49 CFR 40.311 - What are the requirements concerning SAP reports?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What are the requirements concerning SAP reports? 40.311 Section 40.311 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Substance Abuse Professionals and the Return-to-Duty...

76 FR 20804 - Agency Information Collection Activities: Requests for Comments; Clearance of a Renewed Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

... DEPARTMENT OF TRANSPORTATION Office of the Secretary [Docket No. DOT-OST-2011-0057] Agency Information Collection Activities: Requests for Comments; Clearance of a Renewed Approval of Information Collection(s): Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of...

Search and Seizure: What Your School's Rights Are.

ERIC Educational Resources Information Center

Stefkovich, Jacqueline A.; O'Brien, G. Michaele

1996-01-01

Unlike most school-security strategies, search and seizure procedures can be largely determined by studying landmark court cases. The U.S. Supreme Court set standards for conducting school searches in "New Jersey v. T.L.O." (1985) and for drug testing student athletes in "Vernonia School District v. Acton" (1995). School…

10 CFR 707.16 - Records.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Records. 707.16 Section 707.16 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.16 Records. (a) Confirmed positive test...) Contractors shall maintain maximum confidentiality of records related to illegal drug use, to the extent...

49 CFR 40.389 - What factors may the Director consider?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false What factors may the Director consider? 40.389 Section 40.389 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public Interest Exclusions § 40.389 What factors may the...

49 CFR 40.389 - What factors may the Director consider?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What factors may the Director consider? 40.389 Section 40.389 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Public Interest Exclusions § 40.389 What factors may the...

Refrigeration provides a simple means to synchronize in vitro cultures of Plasmodium falciparum.

PubMed

Yuan, Lili; Hao, Mingming; Wu, Lanou; Zhao, Zhen; Rosenthal, Benjamin M; Li, Xiaomei; He, Yongshu; Sun, Ling; Feng, Guohua; Xiang, Zheng; Cui, Liwang; Yang, Zhaoqing

2014-05-01

Plasmodium falciparum is usually asynchronous during in vitro culture. Highly synchronized cultures of P. falciparum are routinely used in malaria research. Here, we describe a simple synchronization procedure for P. falciparum asexual erythrocytic culture, which involves storage at 4°C for 8-24 h followed by routine culture. When cultures with 27-60% of ring stage were synchronized using this procedure, 70-93% ring stages were obtained after 48 h of culture and relative growth synchrony remained for at least two erythrocytic cycles. To test the suitability of this procedure for subsequent work, drug sensitivity assays were performed using four laboratory strains and four freshly adapted clinical P. falciparum isolates. Parasites synchronized by sorbitol treatment or refrigeration showed similar dose-response curves and comparable IC50 values to four antimalarial drugs. The refrigeration synchronization method is simple, inexpensive, time-saving, and should be especially useful when large numbers of P. falciparum culture are handled. Copyright © 2014 Elsevier Inc. All rights reserved.

Refrigeration provides a simple means to synchronize in vitro cultures of Plasmodium falciparum

PubMed Central

Yuan, Lili; Hao, Mingming; Wu, Lanou; Zhao, Zhen; Rosenthal, Benjamin M.; Li, Xiaomei; He, Yongshu; Sun, Ling; Feng, Guohua; Xiang, Zheng; Cui, Liwang; Yang, Zhaoqing

2014-01-01

Plasmodium falciparum is usually asynchronous during in vitro culture. Highly synchronized cultures of Plasmodium falciparum are routinely used in malaria research. Here, we describe a simple synchronization procedure for P. falciparum asexual erythrocytic culture, which involves storage at 4°C for 8–24 h followed by routine culture. When cultures with 27–60% of ring stage were synchronized using this procedure, 70–93% ring stages were obtained after 48 h of culture and relative growth synchrony remained for at least two erythrocytic cycles. To test the suitability of this procedure for subsequent work, drug sensitivity assays were performed using four laboratory strains and four freshly adapted clinical P. falciparum isolates. Parasites synchronized by sorbitol treatment or refrigeration showed similar dose-response curves and comparable IC50 values to four antimalarial drugs. The refrigeration synchronization method is simple, inexpensive, time-saving, and should be especially useful when large numbers of P. falciparum culture are handled. PMID:24632190

Determination of 105 antibiotic, anti-inflammatory, antiparasitic agents and tranquilizers by LC-MS/MS based on an acidic QuEChERS-like extraction.

PubMed

Desmarchelier, Aurélien; Fan, Kaïli; Minh Tien, Mai; Savoy, Marie-Claude; Tarres, Adrienne; Fuger, Denis; Goyon, Alexandre; Bessaire, Thomas; Mottier, Pascal

2018-04-01

A procedure for screening 105 veterinary drugs in foods by liquid chromatography tandem mass-spectrometry (LC-MS/MS) is presented. Its scope encompasses raw materials of animal origin (milk, meat, fish, egg and fat) but also related processed ingredients and finished products commonly used and manufactured by food business operators. Due to the complexity of the matrices considered and to efficiently deal with losses during extraction and matrix effects during MS source ionisation, each sample was analysed twice, that is 'unspiked' and 'spiked at the screening target concentration' using a QuEChERS-like extraction. The entire procedure was validated according to the European Community Reference Laboratories Residues Guidelines. False-negative and false-positive rates were below 5% for all veterinary drugs whatever the food matrix. Effectiveness of the procedure was further demonstrated through participation to five proficiency tests and its ruggedness demonstrated in quality control operations by a second laboratory.

A positive cannabinoids workplace drug test following the ingestion of commercially available hemp seed oil.

PubMed

Struempler, R E; Nelson, G; Urry, F M

1997-01-01

A commercially available health food product of cold-pressed hemp seed oil ingested by one volunteer twice a day for 4 1/2 days (135 mL total). Urine specimens collected from the volunteer were subjected to standard workplace urine drug testing procedures, and the following concentrations of 11-nor-delta9- tetrahydrocannabinol carboxylic acid (9-THCA) were detected: 41 ng/mL 9-THCA at 45 h, 49 ng/mL at 69 h, and 55 ng/mL at 93 h. Ingestion was discontinued after 93 h, and the following concentrations were detected: 68 ng/mL at 108 h, 57 ng/mL at 117 h, 31 ng/mL at 126 h, and 20 ng/mL at 142 h. The first specimen that tested negative (50 ng/mL initial immunoassay test, 15 ng/mL confirmatory gas chromatographic-mass spectrometric test) was at 146 h, which was 53 h after the last hemp seed oil ingestion. Four subsequent specimens taken to 177 h were also negative. This study indicates that a workplace urine drug test positive for cannabinoids may arise from the consumption of commercially available cold-pressed hemp seed oil.

Drug discrimination: A versatile tool for characterization of CNS safety pharmacology and potential for drug abuse.

PubMed

Swedberg, Michael D B

2016-01-01

Drug discrimination studies for assessment of psychoactive properties of drugs in safety pharmacology and drug abuse and drug dependence potential evaluation have traditionally been focused on testing novel compounds against standard drugs for which drug abuse has been documented, e.g. opioids, CNS stimulants, cannabinoids etc. (e.g. Swedberg & Giarola, 2015), and results are interpreted such that the extent to which the test drug causes discriminative effects similar to those of the standard training drug, the test drug would be further characterized as a potential drug of abuse. Regulatory guidance for preclinical assessment of abuse liability by the European Medicines Agency (EMA, 2006), the U.S. Food and Drug Administration (FDA, 2010), the International Conference of Harmonization (ICH, 2009), and the Japanese Ministry of Health Education and Welfare (MHLW, 1994) detail that compounds with central nervous system (CNS) activity, whether by design or not, need abuse and dependence liability assessment. Therefore, drugs with peripheral targets and a potential to enter the CNS, as parent or metabolite, are also within scope (see Swedberg, 2013, for a recent review and strategy). Compounds with novel mechanisms of action present a special challenge due to unknown abuse potential, and should be carefully assessed against defined risk criteria. Apart from compounds sharing mechanisms of action with known drugs of abuse, compounds intended for indications currently treated with drugs with potential for abuse and or dependence are also within scope, regardless of mechanism of action. Examples of such compounds are analgesics, anxiolytics, cognition enhancers, appetite control drugs, sleep control drugs and drugs for psychiatric indications. Recent results (Swedberg et al., 2014; Swedberg & Raboisson, 2014; Swedberg, 2015) on the metabotropic glutamate receptor type 5 (mGluR5) antagonists demonstrate that compounds causing hallucinatory effects in humans did not exhibit clear discriminative effects when tested against classical drugs of abuse in drug discrimination studies, and were not self-administered by rats. However, these compounds did cause salient discriminative effects of their own in animals trained to discriminate them from no drug. Therefore, from a safety pharmacology perspective, novel compounds that do not cause discriminative effects similar to classical drugs of abuse, may still cause psychoactive effects in humans and carry the potential to maintain drug abuse, suggesting that proactive investigation of drug abuse potential is warranted (Swedberg, 2013). These and other findings will be discussed, and the application of drug discrimination procedures beyond the typical standard application of testing novel compounds against known and well characterized reference drugs will be addressed. Copyright © 2016 Elsevier Inc. All rights reserved.

National Cancer Institute Pediatric Preclinical Testing Program: Model Description for In Vitro Cytotoxicity Testing

PubMed Central

Kang, Min H.; Smith, Malcolm A.; Morton, Christopher L.; Keshelava, Nino; Houghton, Peter J.; Reynolds, C. Patrick

2010-01-01

Background The National Cancer Institute (NCI) has established the Pediatric Preclinical Testing Program (PPTP) for testing drugs against in vitro and in vivo childhood cancer models to aid in the prioritization of drugs considered for early phase pediatric clinical trials. Procedures In vitro cytotoxicity testing employs a semi-automated fluorescence-based digital imaging cytotoxicity assay (DIMSCAN) that has a 4-log dynamic range of detection. Curve fitting of the fractional survival data of the cell lines in response to various concentrations of the agents was used to calculate relative IC50, absolute IC50, and Ymin values The panel of 23 pediatric cancer cell lines included leukemia (n=6), lymphoma (n=2), rhabdomyosarcoma (n=4), brain tumors (n=3), Ewing family of tumors (EFT, n=4), and neuroblastoma (n=4). The doubling times obtained using DIMSCAN were incorporated into data analyses to estimate the relationship between input cell numbers and final cell number. Results We report in vitro activity data for three drugs (vincristine, melphalan, and etoposide) that are commonly used for pediatric cancer and for the mTOR inhibitor rapamycin, an agent that is currently under preclinical investigation for cancer. To date, the PPTP has completed in vitro testing of 39 investigational and approved agents for single drug activity and two investigational agents in combination with various “standard” chemotherapy drugs. Conclusions This robust in vitro cytotoxicity testing system for pediatric cancers will enable comparisons to response data for novel agents obtained from xenograft studies and from clinical trials. PMID:20922763

21 CFR 71.30 - Procedure for filing objections to regulations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Procedure for filing objections to regulations. 71.30 Section 71.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVE PETITIONS Administrative Action on Petitions § 71.30 Procedure for filing...

21 CFR 71.30 - Procedure for filing objections to regulations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Procedure for filing objections to regulations. 71.30 Section 71.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVE PETITIONS Administrative Action on Petitions § 71.30 Procedure for filing...

21 CFR 71.30 - Procedure for filing objections to regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Procedure for filing objections to regulations. 71.30 Section 71.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVE PETITIONS Administrative Action on Petitions § 71.30 Procedure for filing...

21 CFR 71.30 - Procedure for filing objections to regulations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Procedure for filing objections to regulations. 71.30 Section 71.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVE PETITIONS Administrative Action on Petitions § 71.30 Procedure for filing...

Infectious Disease Management through Point-of-Care Personalized Medicine Molecular Diagnostic Technologies

PubMed Central

Bissonnette, Luc; Bergeron, Michel G.

2012-01-01

Infectious disease management essentially consists in identifying the microbial cause(s) of an infection, initiating if necessary antimicrobial therapy against microbes, and controlling host reactions to infection. In clinical microbiology, the turnaround time of the diagnostic cycle (>24 hours) often leads to unnecessary suffering and deaths; approaches to relieve this burden include rapid diagnostic procedures and more efficient transmission or interpretation of molecular microbiology results. Although rapid nucleic acid-based diagnostic testing has demonstrated that it can impact on the transmission of hospital-acquired infections, we believe that such life-saving procedures should be performed closer to the patient, in dedicated 24/7 laboratories of healthcare institutions, or ideally at point of care. While personalized medicine generally aims at interrogating the genomic information of a patient, drug metabolism polymorphisms, for example, to guide drug choice and dosage, personalized medicine concepts are applicable in infectious diseases for the (rapid) identification of a disease-causing microbe and determination of its antimicrobial resistance profile, to guide an appropriate antimicrobial treatment for the proper management of the patient. The implementation of point-of-care testing for infectious diseases will require acceptance by medical authorities, new technological and communication platforms, as well as reimbursement practices such that time- and life-saving procedures become available to the largest number of patients. PMID:25562799

[Bioavailability, proof of efficacy and their consequences for drug legislation (author's transl)].

PubMed

Schnieders, B

1976-01-01

Drugs should be effective for the indicatons stated, they should not involve risks which would not be justified in relation to their benefit and they should be of the necessary quality. It is the objective of drug legislation to warrant these requirements in its area of jurisdiction. It has become a necessity to revise current legislation; it is going to be replaced by a new law. A corresponding bill is being considered by Parliament at present. The present and the future legal situation with regards to proof and safeguarding of the bioavailability of pharmacologically active substances and the necessary prerequisites and rules for the procedure of clinical testing of drugs to prove their efficacy and safety is described.

Potential of Surface Enhanced Raman Spectroscopy (SERS) in Therapeutic Drug Monitoring (TDM). A Critical Review

PubMed Central

Jaworska, Aleksandra; Fornasaro, Stefano; Sergo, Valter; Bonifacio, Alois

2016-01-01

Surface-Enhanced Raman Spectroscopy (SERS) is a label-free technique that enables quick monitoring of substances at low concentrations in biological matrices. These advantages make it an attractive tool for the development of point-of-care tests suitable for Therapeutic Drug Monitoring (TDM) of drugs with a narrow therapeutic window, such as chemotherapeutic drugs, immunosuppressants, and various anticonvulsants. In this article, the current applications of SERS in the field of TDM for cancer therapy are discussed in detail and illustrated according to the different strategies and substrates. In particular, future perspectives are provided and special concerns regarding the standardization of self-assembly methods and nanofabrication procedures, quality assurance, and technology readiness are critically evaluated. PMID:27657146

A histidine-rich protein 2-based malaria drug sensitivity assay for field use.

PubMed

Noedl, Harald; Attlmayr, Bernhard; Wernsdorfer, Walther H; Kollaritsch, Herwig; Miller, Robert S

2004-12-01

With the spread of antimalarial drug resistance, simple and reliable tools for the assessment of antimalarial drug resistance, particularly in endemic regions and under field conditions, have become more important than ever before. We therefore developed a histidine-rich protein 2 (HRP2)-based drug sensitivity assay for testing of fresh isolates of Plasmodium falciparum in the field. In contrast to the HRP2 laboratory assay, the field assay uses a procedure that further simplifies the handling and culturing of malaria parasites by omitting centrifugation, washing, the use of serum, and dilution with uninfected red blood cells. A total of 40 fresh Plasmodium falciparum isolates were successfully tested for their susceptibility to dihydroartemisinin, mefloquine, quinine, and chloroquine (50% inhibitory concentration [IC50] = 3.43, 61.89, 326.75, and 185.31 nM, respectively). Results very closely matched those obtained with a modified World Health Organization schizont maturation assay (R2 = 0.96, P < 0.001; mean log difference at IC50 = 0.054).

Principles of laboratory assessment of drug abuse liability and implications for clinical development

PubMed Central

Carter, Lawrence P.; Griffiths, Roland R.

2009-01-01

Abuse liability testing plays an important role in informing drug development, regulatory processes, and clinical practice. This paper describes the current “gold standard” methodologies that are used for laboratory assessments of abuse liability in non-human and human subjects. Particular emphasis is given to procedures such as non-human drug discrimination, self-administration, and physical dependence testing, and human dose effect abuse liability studies that are commonly used in regulatory submissions to governmental agencies. The potential benefits and risks associated with the inclusion of measures of abuse liability in industry-sponsored clinical trials is discussed. Lastly, it is noted that many factors contribute to patterns of drug abuse and dependence outside of the laboratory setting and positive or negative signals in abuse liability studies do not always translate to high or low levels of actual abuse or dependence. Well-designed patient and physician education, pharmacovigilance, and postmarketing surveillance can reduce the diversion and misuse of drugs with abuse liability and can effectively foster the protection and promotion of public health. PMID:19443137

Analysis of the release process of phenylpropanolamine hydrochloride from ethylcellulose matrix granules III. Effects of the dissolution condition on the release process.

PubMed

Fukui, Atsuko; Fujii, Ryuta; Yonezawa, Yorinobu; Sunada, Hisakazu

2006-08-01

In the pharmaceutical preparation of a controlled release drug, it is very important and necessary to understand the entire release properties. As the first step, the dissolution test under various conditions is selected for the in vitro test, and usually the results are analyzed following Drug Approval and Licensing Procedures. In this test, 3 time points for each release ratio, such as 0.2-0.4, 0.4-0.6, and over 0.7, respectively, should be selected in advance. These are analyzed as to whether their values are inside or outside the prescribed aims at each time point. This method is very simple and useful but the details of the release properties can not be clarified or confirmed. The validity of the dissolution test in analysis using a combination of the square-root time law and cube-root law equations to understand all the drug release properties was confirmed by comparing the simulated value with that measured in the previous papers. Dissolution tests under various conditions affecting drug release properties in the human body were then examined, and the results were analyzed by both methods to identify their strengths and weaknesses. Hereafter, the control of pharmaceutical preparation, the manufacturing process, and understanding the drug release properties will be more efficient. It is considered that analysis using the combination of the square-root time law and cube-root law equations is very useful and efficient. The accuracy of predicting drug release properties in the human body was improved and clarified.

Behavioral phenotyping of mice in pharmacological and toxicological research.

PubMed

Karl, Tim; Pabst, Reinhard; von Hörsten, Stephan

2003-07-01

The evaluation of behavioral effects is an important component for the in vivo screening of drugs or potentially toxic compounds in mice. Ideally, such screening should be composed of monitoring general health, sensory functions, and motor abilities, right before specific behavioral domains are tested. A rational strategy in the design and procedure of testing as well as an effective composition of different well-established and reproducible behavioral tests can minimize the risk of false positive and false negative results in drug screening. In the present review we describe such basic considerations in planning experiments, selecting strains of mice, and propose groups of behavioral tasks suitable for a reliable detection of differences in specific behavioral domains in mice. Screening of general health and neurophysiologic functions (reflexes, sensory abilities) and motor function (pole test, wire hang test, beam walking, rotarod, accelerod, and footprint) as well as specific hypothesis-guided testing in the behavioral domains of learning and memory (water maze, radial maze, conditioned fear, and avoidance tasks), emotionality (open field, hole board, elevated plus maze, and object exploration), nociception (tail flick, hot plate), psychiatric-like conditions (porsolt swim test, acoustic startle response, and prepulse inhibition), and aggression (isolation-induced aggression, spontaneous aggression, and territorial aggression) are described in further detail. This review is designed to describe a general approach, which increases reliability of behavioral screening. Furthermore, it provides an overview on a selection of specific procedures suitable for but not limited to behavioral screening in pharmacology and toxicology.

Screening and evaluation of anticancer agents.

PubMed

Zee-Cheng, R K; Cheng, C C

1988-02-01

The screening and evaluation procedures for the development of anticancer agents indicated that the entire process is a rather difficult task. This is particularly true in choosing screening models and criteria for activity. If the criteria were set too low, then some clinically false-positive results may be faced; and if the criteria were set too high, some agents could be missed which might be effective against certain types of human cancer. Presently, active compounds are selected by prescreening and screening against transplanted mouse tumors and human tumor xenografts as well as by the in vitro systems. Xenografts of human tumor in athymic nude animals represent metabolic characteristics of human malignant disease which appear to be of value in the preclinical screening. Human tumor cloning assays have gained increased attention as a promising in vitro test system for the screening as well as for the prediction of patient responses. Application of chemosensitivity tests in the prediction of the responses of individuals to chemotherapy, especially in the identification of drug resistant tumors are, in general, quite reliable. Human tumor xenografts, human tumor cloning assays and chemosensitivity tests may be regarded as the major impetus in screening during the past decade. After promising agents are selected from the screening procedures, before the filing of an investigational new drug application, the preclinical toxicology and pharmacology should be completed. Information on the nature of toxicity, dose-response effects, and dose schedule are necessary for predicting the effects of the drug in man. The new drugs then go through three phases of clinical trials to assure safety, effectiveness, and reliability of the drugs. During the past fifteen years eight-three antineoplastic drugs were evaluated clinically under the NCI sponsorship and twenty-four are active in at least one disease. Among these active drugs, eleven possess novel clinical structure, the remaining thirteen are analogues of known active compounds already in clinical trials. After an investigational anticancer drug is approved by the U.S. Food and Drug Administration it becomes a commercial product on the market and the benefits can be shared by the general public. The time required for evaluation and development from the first discovery of activity to final FDA approval for fifty-two therapeutic drugs are tabled. The average interval is 8.8 years, but in the 1950s the average was only 2.8 years, in the 1960s, 6.5 years; in the 1970s, 13.9 years; and in the 1980s, 16.0 years. This reflects the increasing stricter requirements for an antineoplastic drug to be officially recognize

Rapid susceptibility testing of fungi by flow cytometry using vital staining.

PubMed Central

Wenisch, C; Linnau, K F; Parschalk, B; Zedtwitz-Liebenstein, K; Georgopoulos, A

1997-01-01

A 1-h assay for antifungal susceptibility testing measuring the impairment of fungal metabolic activity was developed. Yeast viability was analyzed by flow cytometry with a novel fluorescent probe, FUN-1, which emits a red fluorescence when the yeast is metabolically active. For nine Candida albicans strains tested, this method yielded results comparable to those obtained by the standard M27 procedure for amphotericin B, flucytosine, fluconazole, and ketoconazole. Whether the flow cytometry antifungal susceptibility test results correlate with the in vivo activities of the drugs remains to determined. PMID:8968873

Reveal Listeria 2.0 test for detection of Listeria spp. in foods and environmental samples.

PubMed

Alles, Susan; Curry, Stephanie; Almy, David; Jagadeesan, Balamurugan; Rice, Jennifer; Mozola, Mark

2012-01-01

A Performance Tested Method validation study was conducted for a new lateral flow immunoassay (Reveal Listeria 2.0) for detection of Listeria spp. in foods and environmental samples. Results of inclusivity testing showed that the test detects all species of Listeria, with the exception of L. grayi. In exclusivity testing conducted under nonselective growth conditions, all non-listeriae tested produced negative Reveal assay results, except for three strains of Lactobacillus spp. However, these lactobacilli are inhibited by the selective Listeria Enrichment Single Step broth enrichment medium used with the Reveal method. Six foods were tested in parallel by the Reveal method and the U.S. Food and Drug Administration/Bacteriological Analytical Manual (FDA/BAM) reference culture procedure. Considering data from both internal and independent laboratory trials, overall sensitivity of the Reveal method relative to that of the FDA/BAM procedure was 101%. Four foods were tested in parallel by the Reveal method and the U.S. Department of Agriculture-Food Safety and Inspection Service (USDA-FSIS) reference culture procedure. Overall sensitivity of the Reveal method relative to that of the USDA-FSIS procedure was 98.2%. There were no statistically significant differences in the number of positives obtained by the Reveal and reference culture procedures in any food trials. In testing of swab or sponge samples from four types of environmental surfaces, sensitivity of Reveal relative to that of the USDA-FSIS reference culture procedure was 127%. For two surface types, differences in the number of positives obtained by the Reveal and reference methods were statistically significant, with more positives by the Reveal method in both cases. Specificity of the Reveal assay was 100%, as there were no unconfirmed positive results obtained in any phase of the testing. Results of ruggedness experiments showed that the Reveal assay is tolerant of modest deviations in test sample volume and device incubation time.

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

Inactivation of the Prelimbic Cortex Impairs the Context-Induced Reinstatement of Ethanol Seeking.

PubMed

Palombo, Paola; Leao, Rodrigo M; Bianchi, Paula C; de Oliveira, Paulo E C; Planeta, Cleopatra da Silva; Cruz, Fábio C

2017-01-01

Evidence indicates that drug relapse in humans is often provoked by exposure to the self-administered drug-associated context. An animal model called "ABA renewal procedure" has been used to study the context-induced relapse to drug seeking. Here, we reported a new and feasible training procedure for the ABA renewal method to explore the role of the prelimbic cortex in context-induced relapse to ethanol seeking. By using a saccharin fading technique, we trained rats to self-administer ethanol (10%). The drug delivery was paired with a discrete tone-light cue. Lever pressing was subsequently extinguished in a non-drug-associated context in the presence of the discrete cue. Rats were subsequently tested for reinstatement in contexts A or B, under extinction conditions. Ethanol-associated context induced the reinstatement of ethanol seeking and increased the expression of Fos in the prelimbic cortex. The rate of neural activation in the prelimbic cortex was 3.4% in the extinction context B and 7.7% in the drug-associated context A, as evidenced by double-labeling of Fos and the neuron-specific protein NeuN. The reversible inactivation of the neural activity in the prelimbic cortex with gamma-Aminobutyric acid (GABA) receptor agonists (muscimol + baclofen) attenuated the context-induced reinstatement of ethanol self-administration. These results demonstrated that the neuronal activation of the prelimbic cortex is involved in the context-induced reinstatement of ethanol seeking.

State of the art in hair analysis for detection of drug and alcohol abuse.

PubMed

Pragst, Fritz; Balikova, Marie A

2006-08-01

Hair differs from other materials used for toxicological analysis because of its unique ability to serve as a long-term storage of foreign substances with respect to the temporal appearance in blood. Over the last 20 years, hair testing has gained increasing attention and recognition for the retrospective investigation of chronic drug abuse as well as intentional or unintentional poisoning. In this paper, we review the physiological basics of hair growth, mechanisms of substance incorporation, analytical methods, result interpretation and practical applications of hair analysis for drugs and other organic substances. Improved chromatographic-mass spectrometric techniques with increased selectivity and sensitivity and new methods of sample preparation have improved detection limits from the ng/mg range to below pg/mg. These technical advances have substantially enhanced the ability to detect numerous drugs and other poisons in hair. For example, it was possible to detect previous administration of a single very low dose in drug-facilitated crimes. In addition to its potential application in large scale workplace drug testing and driving ability examination, hair analysis is also used for detection of gestational drug exposure, cases of criminal liability of drug addicts, diagnosis of chronic intoxication and in postmortem toxicology. Hair has only limited relevance in therapy compliance control. Fatty acid ethyl esters and ethyl glucuronide in hair have proven to be suitable markers for alcohol abuse. Hair analysis for drugs is, however, not a simple routine procedure and needs substantial guidelines throughout the testing process, i.e., from sample collection to results interpretation.

[Continuous challenges in Japanese forensic toxicology practice: strategy to address specific goals].

PubMed

Kageura, Mitsuyoshi

2002-09-01

In this paper, the status quo of forensic toxicology in Japan and the West is surveyed and a strategy to address future goals of Japanese forensic toxicology is proposed. Forensic toxicology in the West consists of three main areas--post-mortem forensic toxicology, human-performance forensic toxicology and forensic urine drug testing. In Japan, post-mortem forensic toxicology is practiced in university forensic medicine departments while most of the human-performance forensic toxicology is carried out in police laboratories. However, at least at present, strictly controlled workplace urine drug testing is not being performed, despite the abuse of drugs even by uniformed members of the National Defence Forces and police. For several years, the author has been introducing Western forensic toxicology guidelines and recommendations, translated into Japanese with the help of Western forensic toxicologists, to Japanese forensic toxicologists. Western forensic toxicology practice is at an advanced stage, whereas Japanese practice is in a critical condition and holds many problems awaiting solution, as exemplified by the urine drug testing in police laboratories. There is never any sample left for re-examination by the defence in all cases, though the initial volume of the urine sample available for examination is 30-50 ml. Only one organisation carries out everything from sampling to reporting and, in addition, the parent drug and its metabolites are not quantified. It is clear that the police laboratories do not work within good laboratory practice guidelines, nor do they have quality manuals or standard operating procedures manuals. A basic change in Japanese forensic toxicology practice is now essential. The author strongly recommends that, first of all, Japanese toxicologists should prepare forensic toxicology guidelines based on the Western models. The guidelines would progress the following objectives for forensic toxicology laboratories: 1) to have documented good laboratory practice standards; 2) to have a quality control system including a quality manual and standard operating procedures manual; 3) to have some degree of compulsion to implement quality assurance both through their own internal efforts and by appropriate remedial actions based on the results of an external proficiency testing scheme. For forensic toxicologists, the implications are that they should be: 1) responsible for ensuring that laboratory practices are performed under satisfactory conditions and 2) required to be certified as a forensic toxicology specialist in order to prove their forensic toxicology ability. For their part, governments should: 1) carry out administrative reforms related to forensic toxicology; 2) simplify the procedure for obtaining certified reference materials; 3) introduce a strict workplace urine drug testing programme for government employees, at least for those related to law enforcement. When all of these objectives have been realised, the specific goal will be achieved through which Japanese forensic toxicology is able, in practice, to fulfill its responsibility to society.

Facile preparation and characterization of pH sensitive Mt/CMC nanocomposite hydrogel beads for propranolol controlled release.

PubMed

Farhadnejad, Hassan; Mortazavi, Seyed Alireza; Erfan, Mohammad; Darbasizadeh, Behzad; Motasadizadeh, Hamidreza; Fatahi, Yousef

2018-05-01

The main aim of the present study was to design pH-sensitive nanocomposite hydrogel beads, based on carboxymethyl cellulose (CMC) and montmorillonite (Mt)-propranolol (PPN) nanohybrid, and evaluate whether the prepared nanocomposite beads could potentially be used as oral drug delivery systems. PPN-as a model drug-was intercalated into the interlayer space of Mt clay mineral via the ion exchange procedure. The resultant nanohybrid (Mt-PPN) was applied to fabricate nanocomposite hydrogel beads by association with carboxymethyl cellulose. The characterization of test samples was performed using different techniques: X-Ray Diffraction (XRD), IR spectroscopy (FT-IR), thermal gravity analysis (TGA), and scanning electron microscopy (SEM). The drug encapsulation efficiency was evaluated by UV-vis spectroscopy, and was found to be high for Mt/CMC beads. In vitro drug release test was performed in the simulated gastrointestinal conditions to evaluate the efficiency of Mt-PPN/CMC nanocomposite beads as a controlled-release drug carrier. The drug release profiles indicated that the Mt-PPN/CMC nanocomposite beads had high stability against stomach acid and a sustained- and controlled-release profile for PPN under the simulated intestinal conditions. Copyright © 2018 Elsevier B.V. All rights reserved.

Fracture characterization of human cortical bone under mode II loading using the end-notched flexure test.

PubMed

Silva, F G A; de Moura, M F S F; Dourado, N; Xavier, J; Pereira, F A M; Morais, J J L; Dias, M I R; Lourenço, P J; Judas, F M

2017-08-01

Fracture characterization of human cortical bone under mode II loading was analyzed using a miniaturized version of the end-notched flexure test. A data reduction scheme based on crack equivalent concept was employed to overcome uncertainties on crack length monitoring during the test. The crack tip shear displacement was experimentally measured using digital image correlation technique to determine the cohesive law that mimics bone fracture behavior under mode II loading. The developed procedure was validated by finite element analysis using cohesive zone modeling considering a trapezoidal with bilinear softening relationship. Experimental load-displacement curves, resistance curves and crack tip shear displacement versus applied displacement were used to validate the numerical procedure. The excellent agreement observed between the numerical and experimental results reveals the appropriateness of the proposed test and procedure to characterize human cortical bone fracture under mode II loading. The proposed methodology can be viewed as a novel valuable tool to be used in parametric and methodical clinical studies regarding features (e.g., age, diseases, drugs) influencing bone shear fracture under mode II loading.

Apparatus bias and place conditioning with ethanol in mice.

PubMed

Cunningham, Christopher L; Ferree, Nikole K; Howard, MacKenzie A

2003-12-01

Although the distinction between "biased" and "unbiased" is generally recognized as an important methodological issue in place conditioning, previous studies have not adequately addressed the distinction between a biased/unbiased apparatus and a biased/unbiased stimulus assignment procedure. Moreover, a review of the recent literature indicates that many reports (70% of 76 papers published in 2001) fail to provide adequate information about apparatus bias. This issue is important because the mechanisms underlying a drug's effect in the place-conditioning procedure may differ depending on whether the apparatus is biased or unbiased. The present studies were designed to assess the impact of apparatus bias and stimulus assignment procedure on ethanol-induced place conditioning in mice (DBA/2 J). A secondary goal was to compare various dependent variables commonly used to index conditioned place preference. Apparatus bias was manipulated by varying the combination of tactile (floor) cues available during preference tests. Experiment 1 used an unbiased apparatus in which the stimulus alternatives were equally preferred during a pre-test as indicated by the group average. Experiment 2 used a biased apparatus in which one of the stimuli was strongly preferred by most mice (mean % time on cue = 67%) during the pre-test. In both studies, the stimulus paired with drug (CS+) was assigned randomly (i.e., an "unbiased" stimulus assignment procedure). Experimental mice received four pairings of CS+ with ethanol (2 g/kg, i.p.) and four pairings of the alternative stimulus (CS-) with saline; control mice received saline on both types of trial. Each experiment concluded with a 60-min choice test. With the unbiased apparatus (experiment 1), significant place conditioning was obtained regardless of whether drug was paired with the subject's initially preferred or non-preferred stimulus. However, with the biased apparatus (experiment 2), place conditioning was apparent only when ethanol was paired with the initially non-preferred cue, and not when it was paired with the initially preferred cue. These conclusions held regardless of which dependent variable was used to index place conditioning, but only if the counterbalancing factor was included in statistical analyses. These studies indicate that apparatus bias plays a major role in determining whether biased assignment of an ethanol-paired stimulus affects ability to demonstrate conditioned place preference. Ethanol's ability to produce conditioned place preference in an unbiased apparatus, regardless of the direction of the initial cue bias, supports previous studies that interpret such findings as evidence of a primary rewarding drug effect. Moreover, these studies suggest that the asymmetrical outcome observed in the biased apparatus is most likely due to a measurement problem (e.g., ceiling effect) rather than to an interaction between the drug's effect and an unconditioned motivational response (e.g., "anxiety") to the initially non-preferred stimulus. More generally, these findings illustrate the importance of providing clear information on apparatus bias in all place-conditioning studies.

21 CFR 320.32 - Procedures for establishing or amending a bioequivalence requirement.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.32 Procedures for...

21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY Food and Drug Administration Privacy Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record...

76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0547] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the rates and...

21 CFR 1270.31 - Written procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Written procedures. 1270.31 Section 1270.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN TISSUE INTENDED...

21 CFR 1301.90 - Employee screening procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Employee screening procedures. 1301.90 Section 1301.90 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE REGISTRATION OF... by non-practitioners is vital to fairly assess the likelihood of an employee committing a drug...

21 CFR 225.165 - Equipment cleanout procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Equipment cleanout procedures. 225.165 Section 225.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Assurance § 225...

10 CFR 712.11 - General requirements for HRP certification.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false General requirements for HRP certification. 712.11 Section 712.11 Energy DEPARTMENT OF ENERGY HUMAN RELIABILITY PROGRAM Establishment of and Procedures for the... provisions of 10 CFR part 707 for DOE contractors, and DOE Order 3792.3, “Drug-Free Federal Workplace Testing...

49 CFR 40.37 - Where is other information on the role of collectors found in this regulation?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false Where is other information on the role of collectors found in this regulation? 40.37 Section 40.37 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Collection...

49 CFR 40.35 - What information about the DER must employers provide to collectors?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What information about the DER must employers provide to collectors? 40.35 Section 40.35 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Collection Personnel § 40.35...

49 CFR 40.37 - Where is other information on the role of collectors found in this regulation?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false Where is other information on the role of collectors found in this regulation? 40.37 Section 40.37 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Collection...