Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations.

Autor: Abend AM; Pharmaceutical Sciences, Merck, 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA. andreas_abend@merck.com., Zhang L; Analytical Strategies and Operation, Bristol Myers Squibb Company, New Brunswick, New Jersey, 08903, USA., Fredro-Kumbaradzi E; Biowaivers, Biocorrelation and Statistical Support, Global Research and Development, Apotex Inc, Toronto, Canada., Hoffelder T; Global Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216, Ingelheim am Rhein, Germany., Cohen MJ; Global Chemistry Manufacturing and Controls, Pfizer Worldwide Research & Development, Groton, Connecticut, USA., Anand O; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Delvadia P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Mandula H; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Zhang Z; Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Kotzagiorgis E; European Medicines Agency, Pharmaceutical Quality Office, 1083 HS, Amsterdam, Netherlands., Lum S; Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Toronto, Canada., Pereira VG; Office of Medicine Quality, Anvisa, SIA, Special Area 57, Brasília, DF, Brazil., Barker A; Global Quality Laboratories, Eli Lilly & Co., Lilly Corporate Center, Indianapolis, Indiana, 46285, USA., Lavrich D; Analytical Commercialization Technology, Merck, 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA., Kraemer J; DISSO GmbH, 66424, Homburg, Germany., Sharp-Suarez S; Regulatory Affairs, Simulations Plus Inc., Lancaster, California, USA.
Jazyk: angličtina
Zdroj: The AAPS journal [AAPS J] 2022 Mar 29; Vol. 24 (3), pp. 50. Date of Electronic Publication: 2022 Mar 29.
DOI: 10.1208/s12248-022-00691-4
Abstrakt: This report summarizes podium presentations and breakout sessions from the second day of the 2019 M-CERSI workshop on In Vitro Dissolution Similarity Assessment in Support of Drug Product Quality: What, How, and When? Presenters from the U.S. Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA), Brazilian Health Surveillance Agency (ANVISA), and the pharmaceutical industry shared experiences/concerns with dissolution profile similarity assessment supporting minor/moderate Chemistry, Manufacturing and Control (CMC) changes. Members from regulatory agencies explained that dissolution profile similarity testing is only part of the overall assessment of the acceptability of the proposed changes; decisions are usually made based on aggregate weight of evidence. Scientific shortcomings of f 2 were highlighted but no proposal on how to replace it was made. Controlling dissolution timepoint variability and application of pairwise batch-to-batch comparisons (PBC) of dissolution profiles caused considerable debate. Several industry participants suggested increased sample sizes to raise confidence in decision-making and to avoid PBC. They proposed identification of a single mathematical method with predefined acceptance criteria and suggested that dissolution timepoint selection should follow EMA and HC guidance. A majority of meeting attendees favored applying clinically relevant dissolution specifications (CRDS) and dissolution safe space to determine the impact of minor/moderate CMC changes as opposed to dissolution profile similarity assessment via statistical methods. Day 2 of the workshop highlighted the need and opportunities for global harmonization including variability, timepoint selection, role of CRDS, and statistical methods to address the ambiguity globally operating pharmaceutical companies are currently facing.
(© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
Databáze: MEDLINE
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