NDLI: Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications

Content Provider	Springer Nature Link
Author	Bhattaram, Venkatesh A. Booth, Brian P. Ramchandani, Roshni P. Beasley, B. Nhi Wang, Yaning Tandon, Veneeta Duan, John Z. Baweja, Raman K. Marroum, Patrick J. Uppoor, Ramana S. Rahman, Nam Atiqur Sahajwalla, Chandrahas G. Powell, J. Robert Mehta, Mehul U. Gobburu, Jogarao V. S.
Copyright Year	2005
Abstract	The value of quantitative thinking in drug development and regulatory review is increasingly being appreciated. Modeling and simulation of data pertaining to pharmacokinetic, pharmacodynamic, and disease progression is often referred to as the pharmacometrics analyses. The objective of the current report is to assess the role of pharmacometrics at the US Food and Drug Administration (FDA) in making drug approval and labeling decisions. The New Drug Applications (NDAs) submitted between 2000 and 2004 to the Cardio-renal, Oncology, and Neuropharmacology drug products divisions were surveyed. For those NDA reviews that included a pharmacometrics consultation, the clinical pharmacology scientists ranked the impact on the regulatory decision(s). Of about a total of 244 NDAs, 42 included a pharmacometrics component. Review of NDAs involved independent, quantitative evaluation by FDA pharmacometricians, even when such analysis was not conducted by the sponsor. Pharmacometric analyses were pivotal in regulatory decision making in more than half of the 42 NDAs. Of the 14 reviews that were pivotal to approval related decisions, 5 identified the need for additional trials, whereas 6 reduced the burden of conducting additional trials. Collaboration among the FDA clinical pharmacology, medical, and statistical reviewers and effective communication with the sponsors was critical for the impact to occur. The survey and the case studies emphasize the need for early interaction between the FDA and sponsors to plan the development more efficiently by appreciating the regulatory expectations better.
Starting Page	E503
Ending Page	E512
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	7
Issue Number	3
e-ISSN	15507416
Language	English
Publisher	Springer-Verlag
Publisher Date	2005-01-01
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	regulatory decisions modeling simulation FDA dose-response Pharmacy Pharmacology/Toxicology Biotechnology
Content Type	Text
Resource Type	Article

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