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generic drug product development
0:14:48
Comparative Analyses: Injectable Combination Products (21of35) Complex Generics – Sep. 25-26, 2019
1:44:40
Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1
1:07:58
New drug discovery and development | pre clinical studie | Clinical studies | innovator and generics
1:34:14
Advancing Generic Drug Development Translating Science to Approval Day 2–Session 8 & Closing Remarks
2:29:20
Navigating Controlled Correspondences to Support Generic Drug Development
0:04:50
GDUFA II Training - Pre ANDA Program Pre Submission Meetings, Robert Lionberger
0:19:58
Lab Science to Support Generic Complex Drug Product Assessment
0:17:17
Keynote from Sally Choe, Director, Office of Generic Drugs (OGD)
0:19:32
Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies
1:01:29
Best Practices for Topical Generic Product Development and ANDA Submission–Introduction & Session 1
0:17:27
Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4of39) Complex Generics 2018
1:42:27
Generic Drugs Forum 2022 – Day 2, Session 1
0:55:15
Harmonization and Global Efforts for Safe and Effective Generic Drugs
0:15:23
Dissolution Method Development for Generic Drugs (24/28) Generic Drugs Forum 2017
1:39:03
Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 2
0:30:23
Pre-ANDA Program Update (2of35) Complex Generics– Sep. 25-26, 2019
0:19:46
In vitro bioequivalence testing for topical ophthalmic suspension products (17of39) Complex Generics
0:32:50
Complex Product Characterization/Analysis - Session 2B
0:06:36
Keynote with Sally Choe (1of35) Complex Generics – Sep. 25-26, 2019
0:37:00
The Patient Voice in Generic Medicine Development
0:13:21
Overview of the FDA Product-Specific Guidance Program
1:47:48
Advancing Generic Drug Development: Translating Science to Approval – Day 2 – Session 5
0:23:06
GDUFA II Pre-ANDA Program Meetings: Advice for Success (10of27) Generic Drugs Forum 2018
0:24:50
Considerations of Particle Analysis (12of35) Complex Generics – Sep. 25-26, 2019
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