Impurity Case Studies: Pharmacology/Toxicology Generic Drugs Forum - Apr. 3-4, 2019

Impurity Case Studies: Pharmacology/Toxicology (22of28) Generic Drugs Forum – Apr. 3-4, 2019

U.S. Food and Drug Administration

Impurity Case Studies- FDA Generic Drug Forum 2019

Questions and Answers (19of28) Generic Drugs Forum – Apr. 3-4, 2019

U.S. Food and Drug Administration

Case Studies: Inadequate Bioequivalence Studies (18of28) Generic Drugs Forum – Apr. 3-4, 2019

U.S. Food and Drug Administration

Questions and Answers (28of28) Generic Drugs Forum – Apr. 3-4, 2019

U.S. Food and Drug Administration

Referencing Approved Drug Products in ANDA Submissions (9of28) Generic Drugs Forum – Apr. 3-4, 2019

U.S. Food and Drug Administration

Stability Case Studies (20of28) Generic Drugs Forum – Apr. 3-4, 2019

U.S. Food and Drug Administration

Drug Master Files (DMFs) from an ANDA Perspective (7of28) Generic Drugs Forum – Apr. 3-4, 2019

U.S. Food and Drug Administration

Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs

U.S. Food and Drug Administration

Manufacturing Process and Controls: Avoiding Assessment Issues (26of28) GDF – Apr. 3-4, 2019

U.S. Food and Drug Administration

Safety Evaluation of Drug Substance Impurities in Generics

U.S. Food and Drug Administration

Decrease RTR, IR, and CR Due to Dissolution Deficiencies (21of28) GDF – Apr. 3-4, 2019

U.S. Food and Drug Administration

Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017

U.S. Food and Drug Administration

Evaluation of Metal Impurities in Drug Substances

U.S. Food and Drug Administration

Selected Case Studies and Impurity Strategies for Drug Substances Part III: Exercise & Conclusion

Regis Technologies, Inc.

Generic Drugs Forum 2022 – Day 2, Session 3

U.S. Food and Drug Administration

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

Introduction to Using (Q)SAR for the Assessment of Potential Mutagenicity of Drug Impurities