Media Summary: Cameron Smith from the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality covers the regulatory pathway for ... Kimberly Witzmann from the Office of Bioequivalence in CDER's Office of 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 - Detailed Analysis & Overview

Cameron Smith from the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality covers the regulatory pathway for ... Kimberly Witzmann from the Office of Bioequivalence in CDER's Office of Deyi Zhang from the Office of Research and Standards in the Office of Andrew J. Fine from the Division of Clinical Review in the Office of Michelle Lin from the Division of Clinical Review in the Office of Xiaoming Xu from the CDER Office of Pharmaceutical Division of Product Quality provides an overview of research, development, ...

Bita Mirzai-Azarm from CDER's Office of Pharmaceutical Quality discusses critical attributes of injectable combination products ... Yan Wang from the Division of Therapeutic Performance in the CDER Office of Presenters Cameron Smith, Deyi Zhang, and Xiaoming Xu answer audience questions. Learn more at ... Bin Qin from the Division of Therapeutic Performance in the Office of Satish Sharan from the Division of Quantitative Methods and Modeling in the Office of Tian Ma from the Office of Bioequivalence in the Office of

Brock Roughton from the Division of Modified Release Products in the Office of Pharmaceutical Quality covers quality by design ... Priyanka Ghosh from the Division of Therapeutic Performance in the Office of Sam Raney from the Division of Therapeutic Performance in CDER's Office of Presenters Karen Bengtson, Suneela Prodduturi and Susan Zuk answer audience questions. Learn more at ... Presenters Yan Wang, Bin Qin, Vidula Kolhatkar, and Bing Cai answer audience questions. Learn more at ... Lisa Bercu, Bing Cai, Kimberly Witzmann, Office of

Photo Gallery

Complex Peptide ANDAs: Test/Reference Comparability (11of35) Complex Generics – Sep. 25-26, 2019
Dose-Scale Analysis in Pharmacodynamic Equivalence (31of35) Complex Generics – Sep. 25-26, 2019
Comparative Analyses: Device and User Interface (25of35) Complex Generics– Sep. 25-26, 2019
Strategies to Demonstrate Complex API Sameness (10of35) Complex Generics – Sep. 25-26, 2019
Comparative Analyses: Injectable Combination Products (21of35) Complex Generics – Sep. 25-26, 2019
Overview of Comparative Analyses - Clinical Perspective (19of35) Complex Generics – Sep. 25-26, 2019
Considerations of Particle Analysis (12of35) Complex Generics – Sep. 25-26, 2019
Quality View on Injectable Product Considerations (20of35) Complex Generic Drugs – Sep. 25-26, 2019
BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019
Questions and Answers (13of35) Complex Generics – Sep. 25-26, 2019
Strategies to Demonstrate Complex Excipient Sameness (15of35) Complex Generics – Sep. 25-26, 2019
Quantitative Clinical Pharmacology in LA Injectables (34of35) Complex Generics – Sep. 25-26, 2019
Sponsored
Sponsored
View Detailed Profile
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 ...

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

Sponsored
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

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

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

Sponsored
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

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, ...

Quality View on Injectable Product Considerations (20of35) Complex Generic Drugs – Sep. 25-26, 2019

Quality View on Injectable Product Considerations (20of35) Complex Generic Drugs – Sep. 25-26, 2019

Bita Mirzai-Azarm from CDER's Office of Pharmaceutical Quality discusses critical attributes of injectable combination products ...

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

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 ...

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

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

BE for Bridging Studies with Orally Inhaled/Nasal Drugs (26of35) Complex Generics – Sep. 25-26, 2019

BE for Bridging Studies with Orally Inhaled/Nasal Drugs (26of35) Complex Generics – Sep. 25-26, 2019

Tian Ma from the Office of Bioequivalence in the Office of

Quality for Transdermal Delivery Systems (8of35) Complex Generic Drugs – Sep. 25-26, 2019

Quality for Transdermal Delivery Systems (8of35) Complex Generic Drugs – Sep. 25-26, 2019

Brock Roughton from the Division of Modified Release Products in the Office of Pharmaceutical Quality covers quality by design ...

Bioequivalence for Generic Topical and Transdermal (6of35) Complex Generics– Sep. 25-26, 2019

Bioequivalence for Generic Topical and Transdermal (6of35) Complex Generics– Sep. 25-26, 2019

Priyanka Ghosh from the Division of Therapeutic Performance in the Office of

Generic Topical and Transdermal Products (5of35) Complex Generics– Sep. 25-26, 2019

Generic Topical and Transdermal Products (5of35) Complex Generics– Sep. 25-26, 2019

Sam Raney from the Division of Therapeutic Performance in CDER's Office of

Referencing Approved Drug Products in ANDA Submissions (9of28) Generic Drugs Forum – Apr. 3-4, 2019

Referencing Approved Drug Products in ANDA Submissions (9of28) Generic Drugs Forum – Apr. 3-4, 2019

CDER 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 ...

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 ...

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