Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008
| Autor: | Pravin R. Jadhav, Lawrence J. Lesko, Fang Li, Christine Garnett, Jogarao V. S. Gobburu, Anshu Marathe, Yaning Wang, Rajnikanth Madabushi, Christoffer W. Tornøe, Hao Zhu, Venkatesh A. Bhattaram, Joo Yeon Lee, Jiang Liu, Satjit Brar, Nitin Mehrotra, Kevin Krudys, Justin C. Earp |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
medicine.medical_specialty
MEDLINE Pharmacology Models Biological Decision Support Techniques Labelling medicine Humans Pharmacology (medical) Medical physics Dosing Investigational New Drug Application License New drug application Drug Labeling Clinical Trials as Topic Dose-Response Relationship Drug business.industry United States Food and Drug Administration Drugs Investigational Pharmacometrics United States Clinical trial Drug development business |
| Zdroj: | Clinical pharmacokinetics. 50(10) |
| ISSN: | 1179-1926 |
| Popis: | Pharmacometric analyses have become an increasingly important component of New Drug Application (NDA) and Biological License Application (BLA) submissions to the US FDA to support drug approval, labelling and trial design decisions. Pharmacometrics is defined as a science that quantifies drug, disease and trial information to aid drug development, therapeutic decisions and/or regulatory decisions. In this report, we present the results of a survey evaluating the impact of pharmacometric analyses on regulatory decisions for 198 submissions during the period from 2000 to 2008. Pharmacometric review of NDAs included independent, quantitative analyses by FDA pharmacometricians, even when such analysis was not conducted by the sponsor, as well as evaluation of the sponsor’s report. During 2000–2008, the number of reviews with pharmacometric analyses increased dramatically and the number of reviews with an impact on approval and labelling also increased in a similar fashion. We also present the impact of pharmacometric analyses on selection of paediatric dosing regimens, approval of regimens that had not been directly studied in clinical trials and provision of evidence of effectiveness to support a single pivotal trial. Case studies are presented to better illustrate the role of pharmacometric analyses in regulatory decision making. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink