Devvrat T. Patel
Center for Drug Evaluation and Research
7 Papers
11 Citations
Devvrat T. Patel is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Bioequivalence & Generic drug. The author has an hindex of 5, co-authored 6 publications. Previous affiliations of Devvrat T. Patel include Food and Drug Administration.
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Papers
Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications
Barbara M. Davit,Dale P. Conner,Beth Fabian-Fritsch,Sam H. Haidar,Xiaojian Jiang,Devvrat T. Patel,Paul Seo,Keri Suh,Christina L. Thompson,Lawrence X. Yu +9 more
TL;DR: It was observed that most of the consistent and borderline highly variable drugs underwent extensive first pass metabolism and drug product dissolution variability was high for about half of the inconsistentlyhighly variable drugs.
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Reconciling sprinkle administration information in approved NDA labeling with sprinkle bioequivalence study recommendations in FDA product-specific guidances for generic drug development
S. C. Chun,Patrick E. Nwakama,Devvrat T. Patel,Ke Ren,April C. Braddy +4 more
- 19 Dec 2022
TL;DR: In this article , the authors searched the FDA external PSG database for availability of respective PSGs containing in vivo sprinkle study recommendations for those modified-release (MR) RLD products with approved NDA labeling for sprinkle administration.
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Analysis of Imprecision in Incurred Sample Reanalysis for Small Molecules
TL;DR: An understanding of the effect of IS imprecision on ISR pass rates and a framework for selection of ISR sample sizes is provided.
9
Bioequivalence of Highly Variable Drugs
Barbara M. Davit,Devvrat T. Patel +1 more
- 01 Jan 2014
TL;DR: A reference-scaled average bioequivalence (RSABE) approach, whereby the BE acceptance limits are scaled to the variability of the reference product, has been implemented successfully by the FDA, to date supporting approvals of both new generic drug products and reformulated modified-release (MR) new drug products.
5
Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration
Barbara M. Davit,Patrick E. Nwakama,Gary Buehler,Dale P. Conner,Sam H. Haidar,Devvrat T. Patel,Yongsheng Yang,Lawrence X. Yu,Janet Woodcock +8 more
TL;DR: The criteria used to evaluate generic drug bioequivalence studies support the FDA's objective of approving generic drug formulations that are therapeutically equivalent to their innovator counterparts.