Module 3 Presentations

07/05/2024

3.2.P.2.1 Drug Product

3.2.P.2.2.1 Formulation Development ● brief summary describing the development of the drug product, taking into consideration the proposed route of administration and usage. ● differences between clinical formulations and the formulation (i.e. composition) described in 3.2.P.1 ● Results from comparative in vitro studies (e.g., dissolution) or comparative in vivo studies (e.g., bioequivalence), when appropriate.

The Organisation for Professionals in Regulatory Affairs

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3.2.P.2.2.1 Formulation Development

The Organisation for Professionals in Regulatory Affairs

22