Journal of Pharmacovigilance

Quality and bioequivalence of modified release products regulatory aspects

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

Muhaned Al-Hindawi

Ontargetpharma Consultancy Limited, UK

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

The most recent position of the European Medicines Agency (EMA) concerning the quality and clinical evaluation of modified release dosage forms reflected by the publication of two separate guidelines is reviewed and the main points discussed in these two guidelines are highlighted. The definition and criteria of modified release products along with the objective behind their clinical use to differ from immediate release dosage forms is covered. Driven by popularity, focus on the quality and bioequivalence of oral modified release products is made. For quality, the development pharmaceutics and choice of composition leading to scaling up to commercial size batches is highlighted. In addition to achieving consistent quality, the importance of pharmaceutical development concept to establish the quality from pharmacokinetic parameters through in vivo drug release to in vitro dissolution is briefly overviewed. The dissolution method criteria being discriminatory, it�??s in vivo implication or link to the quality of the finished product and how comparison between dissolution profiles after variation in order to justify biowaiver is carefully discussed. The effect of alcohol and food on the bioavailability of the drug substance and clinical implication is also discussed. Finally, the requirement for bioequivalence studies of generic modified release product versus the brand as per the SPC recommendation and posology to comply with requirements of the guideline under fast and fed states are covered.

Biography :

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