Media Summary: Xiaoming Xu from the Office of Pharmaceutical Quality discusses Advancing Innovative Science in Generic Drug Changning Guo from the Office of Pharmaceutical Quality discusses new microscopy methods that provide high resolution ...

Developing Validating Commonly Employed Particle - Detailed Analysis & Overview

Xiaoming Xu from the Office of Pharmaceutical Quality discusses Advancing Innovative Science in Generic Drug Changning Guo from the Office of Pharmaceutical Quality discusses new microscopy methods that provide high resolution ... Xiaoming Xu from the CDER Office of Pharmaceutical Division of Product Quality provides an overview of research, Panelists Mindy Ehrenfried, Manivannan Ethirajan, Eric Pang, and Daniela Verthelyi discuss audience questions. Learn more at ... Asif Rasheed, Yan Wang and Hiren Patel discuss audience questions. Learn more at ...

Commissioner of Food and Drugs, Robert M. Califf MD, MACC, delivers his Keynote Address to the 2023 Advancing Generic Drug ... Presenters Changning Guo, Xiaoming Xu, and Meng Hu respond to audience questions. Learn more at ... The discussion begins with an introduction to bioanalytical methods, their importance for FDA submissions, and the method ... Dr. Chris Leptak of the FDA's Center for Drug Evaluation and Research discusses the three primary sources for biomarker ...

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Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality
Developing and Validating Commonly Employed Particle Sizing Methods to Support Bioequivalence BE
Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence
Considerations of Particle Analysis (12of35) Complex Generics – Sep. 25-26, 2019
Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods
Panel on Development and Validation Considerations for Drug Release and Permeation Testing
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 1
Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions
Advancing Generic Drug Development: Translating Science to Approval – Day 1 – Session 3
Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1
Advancing bioanalytical method development and validation for small molecules
Analytical Method Development; From Design to Validation
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Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality

Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality

Xiaoming Xu from the Office of Pharmaceutical Quality discusses

Developing and Validating Commonly Employed Particle Sizing Methods to Support Bioequivalence BE

Developing and Validating Commonly Employed Particle Sizing Methods to Support Bioequivalence BE

Advancing Innovative Science in Generic Drug

Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence

Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence

Changning Guo from the Office of Pharmaceutical Quality discusses new microscopy methods that provide high resolution ...

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,

Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods

Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods

Panelists Mindy Ehrenfried, Manivannan Ethirajan, Eric Pang, and Daniela Verthelyi discuss audience questions. Learn more at ...

Panel on Development and Validation Considerations for Drug Release and Permeation Testing

Panel on Development and Validation Considerations for Drug Release and Permeation Testing

Asif Rasheed, Yan Wang and Hiren Patel discuss audience questions. Learn more at ...

Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 1

Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 1

Commissioner of Food and Drugs, Robert M. Califf MD, MACC, delivers his Keynote Address to the 2023 Advancing Generic Drug ...

Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions

Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions

Presenters Changning Guo, Xiaoming Xu, and Meng Hu respond to audience questions. Learn more at ...

Advancing Generic Drug Development: Translating Science to Approval – Day 1 – Session 3

Advancing Generic Drug Development: Translating Science to Approval – Day 1 – Session 3

This workshop focused on

Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1

Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1

This workshop focused on

Advancing bioanalytical method development and validation for small molecules

Advancing bioanalytical method development and validation for small molecules

The discussion begins with an introduction to bioanalytical methods, their importance for FDA submissions, and the method ...

Analytical Method Development; From Design to Validation

Analytical Method Development; From Design to Validation

Analytical

Pathways for Using Biomarkers in Drug Development

Pathways for Using Biomarkers in Drug Development

Dr. Chris Leptak of the FDA's Center for Drug Evaluation and Research discusses the three primary sources for biomarker ...