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The New EMA Bioequivalence Guideline: Key Considerations
The Biopharmaceutics and Pharmacokinetics Focus Group of the International Association for Pharmaceutical Technology (APV), among other organisations, had the opportunity to comment on the Draft version of the guidance,2 thus leading to this final version.
Overall, key changes have been made to the design and conduct of bioequivalence studies, the application of statistical acceptance criteria and the biowaiver options available in order to replace in vivo bioequivalence trials by in vitro studies.
The question of how to demonstrate and evaluate bioequivalence for drug products is of importance to both innovator and generic drug companies. While previously an in vivo bioequivalence study in humans was required by regulatory bodies to demonstrate bioequivalence, today several alternatives (biowaivers) have been developed to avoid these time consuming and costly studies.
As a result of these modified requirements, APV organised a seminar on 14 June 2010 in Titisee, Germany to discuss "The New EMA Bioequivalence Guideline — What's in it, how to implement it?" A panel of experts, including those actively involved in the development of the guideline revision from industry, academia and regulatory agencies, explained the changes in the regulatory and scientific requirements to meeting attendees.
Peter Langguth, Professor at Johannes Gutenberg-Universitšt in Mainz, Germany, head of the Focus Group and one of the seminar workshop leaders explained: "In order to substantiate the claims on the product label, bioequivalence is a key requirement; it justifies changes in the formulation of drug products from early clinical batches to the marketed drug product and also in the substitution of products containing the same active ingredients. That's why the new guideline effective in August 2010 is of particular importance. The guideline not only provides a thorough description of how pharmacokinetic-based bioequivalence studies should be conducted and evaluated but it also includes recommendations on biowaivers".
The APV seminar has clarified and provided case examples for the additions and modifications made in the latest guidelines.
The most important changes that have been incorporated into the new guidance in comparison to the previous guidance are as
The next project of interest for the Focus Group will be the CPMP announced revision of guidance for oral modified release and transdermal dosage forms. APV will shortly announce its activities encompassing the discussion of these updated guidelines.
APV (International Association for Pharmaceutical Technology) is a non-profit scientific association located in Mainz, Germany. The association publishes EJPB (European Journal of Pharmaceutics and Biopharmaceutics) and organises various events ranging from expert meetings and seminars to in-house trainings. APV also organises international scientific congresses, such as the PBP World Meeting, and is the conceptual sponsor of the TechnoPharm annual meeting in Nuremberg. The organisation is supported by experts from academia and industry.
For detailed information on the APV's workshop programme, please visit www.apv-mainz.de
Peter Langguth is Professor at the Department of Pharmaceutical Technology and Biopharmaceutics at Johannes Gutenberg University, Mainz, Germany and Head of the APV Focus Group Biopharmaceutics and Pharmacokinetics.
1. Guideline on the investigation of bioequivalence (Committee for Medicinal Products for Human Use, EMA, London, UK, 20 January 2010). www.ema.europa.eu
2. D. Barends, et al., Pharm. Ind. 71(2), 258–263 (2009).