April Braddy, Ph.D.

Director
US Food and Drug Administration

(T0930-10-56) Current Drug Substance Stability Issues Related to the Biopharmaceutics Classification System (BCS) Class III -Based Biowaivers in Abbreviated New Drug Applications (ANDAs)

Tuesday, October 22, 2024
9:30 AM – 10:30 AM MT
(M1030-06-32) Analytical Considerations of Drug Products Containing Isomeric Active Pharmaceutical Ingredients in Abbreviated New Drug Application (ANDA) Submissions

Monday, October 21, 2024
10:30 AM – 11:30 AM MT
(M1030-06-34) In Vitro Permeation Test Outlier Data Evaluation during Bioequivalence Assessment of Abbreviated New Drug Applications

Monday, October 21, 2024
10:30 AM – 11:30 AM MT
(T1430-02-09) Evaluation of Methods for Assessing Pre-Dose Steady-State Drug Concentration Attainment in Bioequivalence Studies in Abbreviated New Drug Application (ANDA) Submissions

Tuesday, October 22, 2024
2:30 PM – 3:30 PM MT
(M1430-02-11) Common Bioequivalence (BE) Deficiencies Identified in ANDAs Associated with Solid Oral Extended-Release Drugs in Various Therapeutic Areas: A Retrospective Survey of BE Study Data Submitted to the FDA

Monday, October 21, 2024
2:30 PM – 3:30 PM MT
(M1430-06-35) Avoiding Pitfalls in Selecting Quality Control Concentrations in Surrogate Matrix Approach for Endogenous Drugs

Monday, October 21, 2024
2:30 PM – 3:30 PM MT