Drug development: Improving the process

Food and Drug Law Journal

Volumn 52, Issue 2, 1997, Pages 163-167

  Peck, Carl C ^a  

^a GEORGETOWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MIDAZOLAM; NEW DRUG; ZIDOVUDINE;

CLINICAL PHARMACOLOGY; CLINICAL TRIAL; CONFERENCE PAPER; DOSE RESPONSE; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; THEORY;

CLINICAL TRIALS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030940891     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (4)

1. The intention-to-treat (ITT) policy involves analysis of all clinical trial data in a predetermined fashion, ignoring protocol deviations such as subject drop-outs, noncompliance with study medications, errors in randomized allocations of treatments, etc.
2. N.H.G. Holford & C.C. Peck, Population Pharmacodynamics and Drug Development, in THE IN VIVO STUDY OF DRUG ACTION: PRINCIPLES AND APPLICATIONS OF KINETIC DYNAMIC MODELING (C.J. van Boxtel, N.H.G. Holford & M. Danhof eds. 1992).
3. See M. Hale et al., Clinical Trial Simulation: Streamlining Your Drug Development Process, 5 APPLIED CLIN. TRIALS 35 (1996); C.C. Peck & R.E. Desjardins, Simulation of Clinical Trials: Encouragement and Cautions, 5 APPLIED CLIN. TRIALS 30 (1996).
4. See M. Hale et al., Clinical Trial Simulation: Streamlining Your Drug Development Process, 5 APPLIED CLIN. TRIALS 35 (1996); C.C. Peck & R.E. Desjardins, Simulation of Clinical Trials: Encouragement and Cautions, 5 APPLIED CLIN. TRIALS 30 (1996).