A 2019 workshop highlighted current practices to assess dissolution profile similarity.
“The pharmaceutical industry and regulatory agencies rely on dissolution similarity testing to make critical product performance decisions as part of drug product life cycle management,” explains Sandra Suarez-Sharp, Andreas Abend, Thomas Hoffelder, et al. in the recently published AAPS Journal article In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report. This article is part of the digital theme issue Current and Novel Approaches towards Dissolution Profile Comparison Harmonization, guest edited by Andreas Abend, Dorys Argelia Diaz, and Sandra Suarez-Sharp.
The authors summarize presentations and breakout session discussions from the 2019 University of Maryland, Baltimore, workshop In Vitro Dissolution Similarity Assessment in Support of Drug Product Quality: What, How, When, which was formed to “highlight current practices to assess dissolution profile similarity and to strive towards global harmonization.”
Dissolution testing is used to evaluate the impact of chemistry, manufacturing, and controls variations within a formulation, which may undergo changes in composition, manufacturing process, or manufacturing site during the lifecycle of the drug.
The Food and Drug Administration, the European Medicines Agency, and other regulatory agencies worldwide provide guidances on the use of mathematical approaches to evaluate dissolution profile similarity. However, those guidances are not harmonized around the similarity factor f2 and other statistical approaches.
Key points highlighted in this AAPS Journal article include: “(1) contrasting the advantages and disadvantages of several statistical methods; (2) the importance of experimental design for successful similarity evaluation; (3) the value of similarity evaluation in light of clinically relevant specifications; and (4) the need for creating a robust and scientifically appropriate path (e.g., non-prescriptive decision tree) for dissolution profile similarity assessment as a stepping stone for global harmonization.”
While the meeting participants agreed on the need for harmonized guidance, “[they] were not unified as far as the need to develop a decision tree to guide the ‘selection’ of the appropriate statistical method to be used when f2 cannot be applied.”
Read the full article to learn more about the sessions and conversations at this important workshop on the harmonization of dissolution testing standards. This article is free access through August 2020, so make sure to read and share with your colleagues! You can always read articles in AAPS’ journals for free as an AAPS member. Join today!
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