Media Summary: Xiaoming Xu from the CDER Office of Pharmaceutical Division of Product Quality provides an overview of research, development, ... Lisa Bercu, Bing Cai, Kimberly Witzmann, Office of Presenters Cameron Smith, Deyi Zhang, and Xiaoming Xu answer audience questions. Learn more at ...

Considerations Of Particle Analysis 12of35 Complex Generics Sep 25 26 2019 - Detailed Analysis & Overview

Xiaoming Xu from the CDER Office of Pharmaceutical Division of Product Quality provides an overview of research, development, ... Lisa Bercu, Bing Cai, Kimberly Witzmann, Office of Presenters Cameron Smith, Deyi Zhang, and Xiaoming Xu answer audience questions. Learn more at ... Michelle Lin from the Division of Clinical Review in the Office of Presenters Karen Bengtson, Suneela Prodduturi and Susan Zuk answer audience questions. Learn more at ... Kimberly Witzmann from the Office of Bioequivalence in CDER's Office of

Presenters Yan Wang, Bin Qin, Vidula Kolhatkar, and Bing Cai answer audience questions. Learn more at ... Yan Wang from the Division of Therapeutic Performance in the CDER Office of Ross Walenga in the Division of Quantitative Methods and Modeling in the Office of Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of Liang Zhao from the Division of Quantitative Methods and Modeling in the Office of Satish Sharan from the Division of Quantitative Methods and Modeling in the Office of

Andrew J. Fine from the Division of Clinical Review in the Office of Lisa Bercu, Regulatory Counsel in the Office of Deyi Zhang from the Office of Research and Standards in the Office of Cameron Smith from the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality covers the regulatory pathway for ... Bin Qin from the Division of Therapeutic Performance in the Office of Liang Zhao, Yaning Wang, Robert Lionberger, and Murray Ducharme from Learn and Confirm, Inc., respond to audience ...

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Considerations of Particle Analysis (12of35) Complex Generics – Sep. 25-26, 2019
Questions and Answers (22of35) Complex Generics – Sep. 25-26, 2019
Questions and Answers (13of35) Complex Generics – Sep. 25-26, 2019
Overview of Comparative Analyses - Clinical Perspective (19of35) Complex Generics – Sep. 25-26, 2019
Questions and Answers (4of35) Complex Generics – Sep. 25-26, 2019
Comparative Analyses: Device and User Interface (25of35) Complex Generics– Sep. 25-26, 2019
Questions and Answers (17of35) Complex Generics – Sep. 25-26, 2019
BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019
Credibility for Computational Fluid Dynamics Models (33of35) Complex Generics – Sep. 25-26, 2019
Dose-Scale Analysis in Pharmacodynamic Equivalence (31of35) Complex Generics – Sep. 25-26, 2019
Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019
Quantitative Methods and Modeling (29of35) Complex Generics – Sep. 25-26, 2019
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Considerations of Particle Analysis (12of35) Complex Generics – Sep. 25-26, 2019

Considerations of Particle Analysis (12of35) Complex Generics – Sep. 25-26, 2019

Xiaoming Xu from the CDER Office of Pharmaceutical Division of Product Quality provides an overview of research, development, ...

Questions and Answers (22of35) Complex Generics – Sep. 25-26, 2019

Questions and Answers (22of35) Complex Generics – Sep. 25-26, 2019

Lisa Bercu, Bing Cai, Kimberly Witzmann, Office of

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Questions and Answers (13of35) Complex Generics – Sep. 25-26, 2019

Questions and Answers (13of35) Complex Generics – Sep. 25-26, 2019

Presenters Cameron Smith, Deyi Zhang, and Xiaoming Xu answer audience questions. Learn more at ...

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

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

Michelle Lin from the Division of Clinical Review in the Office of

Questions and Answers (4of35) Complex Generics – Sep. 25-26, 2019

Questions and Answers (4of35) Complex Generics – Sep. 25-26, 2019

Presenters Karen Bengtson, Suneela Prodduturi and Susan Zuk answer audience questions. Learn more at ...

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

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

Kimberly Witzmann from the Office of Bioequivalence in CDER's Office of

Questions and Answers (17of35) Complex Generics – Sep. 25-26, 2019

Questions and Answers (17of35) Complex Generics – Sep. 25-26, 2019

Presenters Yan Wang, Bin Qin, Vidula Kolhatkar, and Bing Cai answer audience questions. Learn more at ...

BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019

BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019

Yan Wang from the Division of Therapeutic Performance in the CDER Office of

Credibility for Computational Fluid Dynamics Models (33of35) Complex Generics – Sep. 25-26, 2019

Credibility for Computational Fluid Dynamics Models (33of35) Complex Generics – Sep. 25-26, 2019

Ross Walenga in the Division of Quantitative Methods and Modeling in the Office of

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

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

Xiajing (Jean) Gong from CDER Office

Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019

Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019

Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of

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

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

Liang Zhao from the Division of Quantitative Methods and Modeling in the Office of

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

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

Satish Sharan from the Division of Quantitative Methods and Modeling in the Office of

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

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

Andrew J. Fine from the Division of Clinical Review in the Office of

Keynote with Sally Choe (1of35) Complex Generics – Sep. 25-26, 2019

Keynote with Sally Choe (1of35) Complex Generics – Sep. 25-26, 2019

Director of the Office of

What Constitutes Complex Drug-Device Combination (18of35) Complex Generics – Sep. 25-26, 2019

What Constitutes Complex Drug-Device Combination (18of35) Complex Generics – Sep. 25-26, 2019

Lisa Bercu, Regulatory Counsel in the Office of

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

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

Deyi Zhang from the Office of Research and Standards in the Office of

Complex Peptide ANDAs: Test/Reference Comparability (11of35) Complex Generics – Sep. 25-26, 2019

Complex Peptide ANDAs: Test/Reference Comparability (11of35) Complex Generics – Sep. 25-26, 2019

Cameron Smith from the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality covers the regulatory pathway for ...

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

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

Bin Qin from the Division of Therapeutic Performance in the Office of

Panel Questions and Discussion (35of35) Complex Generics – Sep. 25-26, 2019

Panel Questions and Discussion (35of35) Complex Generics – Sep. 25-26, 2019

Liang Zhao, Yaning Wang, Robert Lionberger, and Murray Ducharme from Learn and Confirm, Inc., respond to audience ...