Early human microdosing to reduce attrition in clinical drug development

American Pharmaceutical Outsourcing

Volumn 4, Issue 5, 2003, Pages 42-47

  Sarapa, Nenad ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ANALYTIC METHOD; ARTICLE; CLINICAL RESEARCH; DOSIMETRY; DRUG DETERMINATION; DRUG DISPOSITION; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG METABOLISM; DRUG PROGRAM; DRUG RESEARCH; DRUG SAFETY; DRUG SYNTHESIS; HUMAN; INTERMETHOD COMPARISON; MASS SPECTROMETRY; POSITRON EMISSION TOMOGRAPHY; PROCESS OPTIMIZATION; REGISTRATION; SENSITIVITY ANALYSIS; SINGLE DRUG DOSE; STANDARDIZATION; VALIDATION PROCESS;

EID: 0242363768     PISSN: 15296318     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. Lesko L.J., Rowland M, Peck C.C., Blaschke T.F. Optimizing the Science of Drug Development: Opportunities for Better Candidate Selection and Accelerated Evaluation in Humans. Pharmaceutical Research 2000; 17:1335.
2. Reigner B.G., Williams P.E.O., Patel I.H. et al. Integration of PK/PD has Improved Recent Roche Drug Development. Clinical Pharmacology and Therapeutics 1996;59:191.
3. Lappin G., Garner R.C. Big Physics, Small Doses: The Use of AMS and PET in Human Microdosing of Development Drugs. Nature Reviews Drug Discovery 2003;7:233.
4. European Agency for the Evaluation of Medicines for Human Use (EMEA). Position Paper on the Nonclinical Safety Studies to Support Clinical Trials with a Single Microdose. CPMP/SWP2599/02, 28 January 2003.
5. ICH Harmonized Tripartite Guideline (M3). Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, issued 16 July 1997 and amended, 09 November 2000.
6. Smith D.A., Johnson D.E., Park B.K. Use of Microdosing to Probe Pharmacokinetics in Humans - Is it Too Much for Too Little? Current Opinion in Drug Discovery and Development 2003;6:39.
7. Food and Drug Administration Guidance for Industry: Single Dose Acute Toxicity Testing for Pharmaceuticals. Center for Drug Evaluation and Research, August 1996.