Webinar Session 6: Challenges and Issues in Meeting Regulatory Requirements for In Vitro Dissolution Testing

  • Wednesday, February 23, 2022
  • 11:00 AM - 1:00 PM

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Join us Wednesday, February 23, 2022 for our next webinar session.
SAAMnow will present its sixth webinar session on February 23, 2022. The session will be up to 2 hours duration with three presentations of 30-40 minutes followed by chat questions and answers. 

Why Should You Attend:
This session will feature three speakers (James Polli, Sandra Suarez-Sharp and Thomas Hoffelder) and will focus on the challenges and issues in meeting regulatory requirements for in vitro dissolution testing.

The f2 parameter in dissolution testing of solid oral dose products is a standard tool for assessing similarity of dissolution profiles for obtaining biowaivers in an ANDA and under SUPAC. To conclude that two dissolution curves are similar, the value for f2 must be between 50 and 100. FDA restricts the use of the standard calculation of the f2 parameter to situations where the relative standard deviation (RSD) is not more than 20% at the earlier time points and not more than 10% at other time points. Although the FDA recommends alternative methods when high variability exists, how to use these methods and interpret the results is often unclear. This is especially true considering FDA’s evolving position on dissolution profile comparisons. 

Via this webinar we want to fill the gap in understanding the various methods being advocated by FDA to evaluate similarity of dissolution profiles and how to apply these methods.
Webinar Session 6: Challenges and Issues in Meeting Regulatory Requirements for In Vitro Dissolution Testing
When: Wednesday, February 23rd  | 11:00 am EST (Eastern US) | Duration: 120 minutes

Presenter 1: James Polli, PhD, Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell 
Endowed Professor in Industrial Pharmacy and Pharmaceutics, University of Maryland:
Biopharmaceutical Considerations in Dissolution

Areas Covered:
This presentation will provide an overview of biopharmaceutical considerations in dissolution testing including the following:

  • Dissolution in M9 and further opportunities for harmonization 
  • Justifying f2 values <50 based on pharmaceutics considerations 

Presenter 2: Sandra Suarez-Sharp, PhD, Vice President Regulatory Affairs, Simulations Plus, Inc: 
Rational Implementation of Dissolution Similarity Testing in Support of Regulatory Decision Making

Areas Covered:
This presentation will provide details on how to apply dissolution similarity testing in the current regulatory environment including the following:

  • SUPAC – post-change versus pre-change comparisons 
  • Biowaivers: non-biostudy strengths and BCS classification 
  • In-vitro bioequivalence: NDA vs. ANDA requirements

Presenter 3: Thomas Hoffelder, Non-Clinical Statistician for Boehringer Ingelheim: 
Dissolution Profile Similarly Analyses – Statistical Considerations

Areas Covered:
This presentation will discuss the various statistical methods used to evaluate similarity of dissolution profiles including the following:
•    Dissolution Statistics:  MSD vs f2
•    What to do when there is more than a single lot of Test and Reference