What non-clinical toxicology and safety pharmacology data are needed to accelerate phase I-II clinical trials?

American Pharmaceutical Outsourcing

Volumn 5, Issue 2, 2004, Pages 30-43

  Dixit, Rakesh ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ACUTE TOXICITY; AREA UNDER THE CURVE; CLINICAL STUDY; DECISION MAKING; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG EXCRETION; DRUG METABOLISM; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; DRUG SYNTHESIS; DRUG TOLERABILITY; EXPERIMENTAL DESIGN; GENOTOXICITY; GOVERNMENT REGULATION; MULTIPLE DRUG DOSE; NONHUMAN; PHARMACODYNAMICS; PRACTICE GUIDELINE; REPRODUCTIVE TOXICITY; REVIEW; RISK ASSESSMENT; RODENT; SINGLE DRUG DOSE; TOXICITY TESTING; TREATMENT PLANNING;

EID: 1942435974     PISSN: 15296318     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (12)

1. Pritchard, J., Jurima-Romet, M., Reimer, M., Mortimer, E., Rolfe, B. and Cayen, M, Nature Reviews: Drug Discovery 2003: 2, 542.
2. ICH Harmonized Tripartite Guideline (s6): General Consideration for Clinical Trials. Federal Register 1997: 62 FR, 66113.
3. ICH Harmonized Tripartite Guideline (M3): Non-clinical Safety Studies for the Conduct of Human Clinical Trials For Pharmaceutical. Federal Register 1997: 62 FR, 62922.
4. ICH Harmonized Tripartite Guideline (S2A): Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. Federal Register 1996: 61 FR, 18199.
5. ICH Harmonized Tripartite Guideline (S2B): Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals. Federal Register 1997: 62 FR, 624721.
6. US FDA, Single Dose Acute Toxicity Testing for Pharmaceuticals: Revised Guidance. Federal Register 1996. 61 FR, 43934
7. European Agency for the Evaluation of Medicines for Human Use (EMEA) Position Paper on Non-clinical Safety Studies to Support Clinical Trials with a Single Microdose. CPMP/SWP2599/02, 28-January 2003.
8. ICH Harmonized Tripartite Guideline (S7A): Safety Pharmacology Studies for Human Pharmaceuticals. 2001.
9. ICH Harmonized Tripartite Guideline (S3A): Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies. Federal Register 1995: 60 FR, 11264.
10. Dixit, R., Riviere, J., Krishnan, K., and Andersen, M.E. Toxicokinetics and Physiologically based Toxicokinetics in Toxicology and Risk Assessment. Journal of Toxicology and Environmental Health, Part B. 2003: Critical Reviews. 6(1), 1-40.
11. ICH Harmonized Tripartite Guideline (S5A): Detection of Toxicity to Reproduction for Medicinal Products. Federal Register 1994: 59 FR, 48746.
12. Good Laboratory Practice Regulations For Non-clinical Laboratory Studies, Federal Register 21CFR Part 58, June 20, 1979 and all subsequent amendments.