Case Studies: Inadequate Bioequivalence Studies (18of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 23:31 4 years ago 676 Скачать Далее
Stability Case Studies (20of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 46:55 4 years ago 842 Скачать Далее
Impurity Case Studies: Pharmacology/Toxicology (22of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 25:40 4 years ago 1 674 Скачать Далее
Orange Book - Its Role in ANDAs (8of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 16:29 4 years ago 921 Скачать Далее
Complex Product Development (3of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 23:10 4 years ago 653 Скачать Далее
Filing and Refuse to Receive (RTR) (16of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 21:56 4 years ago 784 Скачать Далее
Questions and Answers (28of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 10:36 4 years ago 632 Скачать Далее
Referencing Approved Drug Products in ANDA Submissions (9of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 16:19 4 years ago 1 411 Скачать Далее
Drug Master Files (DMFs) from an ANDA Perspective (7of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 42:28 4 years ago 1 772 Скачать Далее
Pre-ANDA Meeting or Controlled Correspondence? (4of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 19:49 4 years ago 1 029 Скачать Далее
Tips on Using the CDER NextGen Collaboration Portal (12of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 12:48 4 years ago 861 Скачать Далее
Keynote: Generic Drug Program Update (1of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 20:05 4 years ago 340 Скачать Далее
Manufacturing Process and Controls: Avoiding Assessment Issues (26of28) GDF – Apr. 3-4, 2019 U.S. Food and Drug Administration 45:48 4 years ago 1 242 Скачать Далее
505(b)(2) NDA or ANDA? (10of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 20:08 4 years ago 4 967 Скачать Далее
Best Practices for Conducting Bioequivalence Studies (16of27) Generic Drugs Forum 2018 U.S. Food and Drug Administration 30:26 4 years ago 3 449 Скачать Далее
Review of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 19:20 3 years ago 1 478 Скачать Далее
Decrease RTR, IR, and CR Due to Dissolution Deficiencies (21of28) GDF – Apr. 3-4, 2019 U.S. Food and Drug Administration 35:21 4 years ago 1 648 Скачать Далее
A New Possible Way to Evaluate Bioequivalence of Topical Drugs U.S. Food and Drug Administration 0:54 5 years ago 2 675 Скачать Далее
Integrated Process and Facilities Assessment (26of27) Generic Drugs Forum 2018 U.S. Food and Drug Administration 25:50 4 years ago 976 Скачать Далее
