Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
The End-of-Phase 2A meetings are proposed to identify opportunities to make innovative medical products available sooner and to increase the quality of drug applications through early meetings between sponsors and the FDA. This article summarizes the overall experience across 11 pilot End-of-Phase 2A meetings since 2004. Four case studies are presented in more detail to demonstrate the various issues and methods encountered at these meetings. Overall, industry and FDA scientists ranked these meetings to be "very helpful" (average score of 4 on a scale of 1 to 5). In almost all the instances the sponsors changed their drug development plans subsequent to these extensive quantitative analyses-based meetings. A draft Guidance is being developed to be issued in 2008, and we hope this initiative will be resourced by then.
Wang
Yaning
Y
Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993-0002, USA. yaning.wang@fda.hhs.gov
Bhattaram
A Venkatesh
AV
Jadhav
Pravin R
PR
Lesko
Lawrence J
LJ
Madabushi
Rajanikanth
R
Powell
J Robert
JR
Qiu
Wei
W
Sun
He
H
Yim
Dong S
DS
Zheng
Jenny J
JJ
Gobburu
Jogarao V S
JV
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D003657:Decision Making; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods / Q000706:statistics & numerical data; D004345:Drug Industry / Q000331:legislation & jurisprudence; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence / Q000379:methods / Q000706:statistics & numerical data; D007880:Legislation, Drug / Q000592:standards; D009937:Organizational Objectives; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000458:organization & administration / Q000592:standards