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Clinical Pharmacology and Biopharmaceutics Review Template Fda Form

Clinical Pharmacology and Biopharmaceutics Review Template Fda Form

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good morning and thanks a lot for the very kind introduction it's a pleasure to be here today to share my experience with regulatory review of by analysis specifically in the very similar space in this presentation I will start with a brief background about the biosimilars from a regulatory perspective and then move on to the typical components of a biosimilars application specifically the portions that are related to clinical pharmacology and pharmacokinetics assessment of the main objective of this background section is to highlight the very important role of bio analysis in the review of the by similar applications in the following section I will share with you some interesting case examples to highlight the importance of good practices in terms of assay validation and sample analysis I will conclude my presentation with a set of recommendations and provide references to what the FDA generally expects from a bio analysis perspective through the biologics price competition an

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