Virtual | Virtual
Event Title
A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
March 14, 2023
- Date:
- March 14, 2023
- Time:
- 10:00 AM - 12:00 PM ET
Topic & Presentations |
Speakers |
---|---|
FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence |
|
Liang Zhao, PhD |
|
Stella C. Grosser, PhD |
|
Sungwoo Choi, PhD |
|
Kimberly Raines, PhD |
|
Statistical Methods for Narrow Therapeutic Index and Highly Variable Drug Products |
Donald Schuirmann, MS |
Fairouz Makhlouf, PhD |
|
Wanjie Sun, PhD |
|
Wanjie Sun, PhD |
|
Bioequivalence Statistics for Adhesion and Irritation Studies |
Somesh Chattopadhyay, PhD |
Meng Hu, PhD |
|
Zhen Zhang, PhD |
|
Q&A Panel Discussion |
Speakers mentioned above Including: Lanyan (Lucy) Fang, PhD Ying Fan, PhD
|
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ABOUT THIS WEBINAR
In December 2022, FDA issued a draft guidance for industry entitled Statistical Approaches to Establishing Bioequivalence, which provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. This guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches generally and in specific situations. When finalized, this guidance will replace the February 2001 FDA guidance for industry “Statistical Approaches to Establishing Bioequivalence” and will represent FDA’s current thinking on this topic.
This webinar will take a deeper look into the draft guidance for new and revised content and provide clarification to comments received through the public docket.
TOPICS COVERED
- In Vitro Bioequivalence assessment
- Statistical Methods for Narrow Therapeutic Index and Highly Variable Drug Products
- Comparative Clinical Endpoint Bioequivalence Studies
- Studies in Multiple Groups
- Bioequivalence Statistics for Adhesion and Irritation Studies
- Dose Scale for Bioequivalence Assessment
LEARNING OBJECTIVES
- Provide an overview of the draft guidance
- Describe the major changes in the draft guidance from the 2001 guidance
- Provide clarification and rationale on selected topics to address comments received
INTENDED AUDIENCE
- Generic and new drug industry, including current and potential applicants who are interested in submitting an application for a generic drug or a new drug
- Regulatory reviewers for generic and new drug development and assessments
- Researchers working on generic drugs and new drugs
- Consultants focused on bioequivalence
- Clinical research coordinators
- Healthcare professionals specializing in prescribing and dispensing medications
- Foreign regulators
FDA RESOURCES
- FDA Draft Guidance: Statistical Approaches to Establishing Bioequivalence (December 2022)
- FDA Guidance: Bioequivalence Recommendations for Specific Products (June 2010)
- Product-Specific Guidances for Generic Drug Development (main page)
- FDA Draft Guidance: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (August 2021)
- FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations (April 2022)