Clinical Pharmacology and Pharmacokinetics: Questions and Answers

16 December 2022 – the EMA published updated Q&A guidance on guideline requirements for parenteral oily solutions.

Section 3 Bioequivalence (general) - Question 3.12:

Clarification on Appendix II of the Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1/Corr**) on whether viscosity and/or other in vitro comparative data are needed to demonstrate comparable physicochemical characteristics of oily solutions, sufficient to support a biowaiver.

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