Complexgenerics

The Center for Research on Complex Generics

University of Maryland School of Pharmacy

Complex Generics: Topical Products, Part 1

U.S. Food and Drug Administration

Cutting Edge Science in Complex Generics

U.S. Food and Drug Administration

Overview of Current Science-Based Regulatory Standards (21of39) Complex Generics 2018

U.S. Food and Drug Administration

Complex Generics: Topical Products, Part 2

U.S. Food and Drug Administration

Overview of Comparative Analyses - Clinical Perspective (19of35) Complex Generics – Sep. 25-26, 2019

U.S. Food and Drug Administration

Combination Products: User-interface & Role of Comparative Analyses (29of39) Complex Generics 2018

U.S. Food and Drug Administration

Quantitative Methods and Modeling (29of35) Complex Generics – Sep. 25-26, 2019

U.S. Food and Drug Administration

Office of Generic Drugs Keynote (1of39) Complex Generics 2018

U.S. Food and Drug Administration

Strategies to Demonstrate Complex API Sameness (10of35) Complex Generics – Sep. 25-26, 2019

U.S. Food and Drug Administration

Strategies to Demonstrate Complex Excipient Sameness (15of35) Complex Generics – Sep. 25-26, 2019

U.S. Food and Drug Administration

Quantitative Clinical Pharmacology in LA Injectables (34of35) Complex Generics – Sep. 25-26, 2019

U.S. Food and Drug Administration

Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4of39) Complex Generics 2018

U.S. Food and Drug Administration

Dose-Scale Analysis in Pharmacodynamic Equivalence (31of35) Complex Generics – Sep. 25-26, 2019

U.S. Food and Drug Administration

In Vitro Release Testing for Complex Generics: A Bioequivalence Perspective

U.S. Food and Drug Administration

FDA’s Inactive Ingredient Database (IID) (3of35) Complex Generics – Sep. 25-26, 2019

U.S. Food and Drug Administration

Comparative Analyses: Injectable Combination Products (21of35) Complex Generics – Sep. 25-26, 2019

U.S. Food and Drug Administration

In Vitro Release Testing of Complex Formulations (11of39) Complex Generics 2018

U.S. Food and Drug Administration

About the Center for Research on Complex Generics

Center for Research on Complex Generics (CRCG)

Comparative Analyses: Device and User Interface (25of35) Complex Generics– Sep. 25-26, 2019

U.S. Food and Drug Administration