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  4. A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence - 03/14/2023
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Event Title
A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
March 14, 2023

March 14, 2023
10:00 AM - 12:00 PM ET


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In December 2022, FDA issued a draft guidance for industry entitled Statistical Approaches to Establishing Bioequivalence, which provides recommendations to sponsors and applicants who intend to use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This webinar will take a deeper look into the draft guidance for new and revised content and provide clarification to comments received through the public docket.


  • 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


  • Provide an overview of the draft guidance
  • Describe the major changes in the draft guidance from the 2001 guidance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


  • 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


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