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Agenda

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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In December 2022, FDA issued a draft guidance for industry entitled Statistical Approaches to Establishing Bioequivalence, which provides recommendations to sponsors and applicants who intend to use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This webinar will take a deeper look into the draft guidance for new and revised content and provide clarification to comments received through the public docket.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• Provide an overview of the draft guidance
• Describe the major changes in the draft guidance from the 2001 guidance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

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This webinar has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

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