picture of Cardot Jean Michel

Prof. Jean-Michel Cardot

Pharm D, Ph. D.

Consultant for SAS Borvo

France

EMA published some new requirements for dissolution in the two last years. The description of the new requirements for delayed release formulation and for F2 calculation are presented associated with examples and impact on dossier submission.

Since the publication of the guidelines on LALA in GIT Q&A and product specific guidance were published. The description of the requirements are presented. Three examples: lozenges, antiacid drug, and drug acting through chelation are presented to illustrate the current requirement. A specific point will be made on the difference between EMA and FDA on acceptance criteria.

About the speaker:

He was Professor and head of the Department of Biopharmaceutics and Pharmaceutical Technology from the Auvergne University, France from 2002 to 2021. Before joining University, he was in research department of pharmaceutical industries in Switzerland and in France.

His research fields are Biopharmaceutical development of drugs, in vitro dissolution and in vivo bioequivalence and in vitro-in vivo correlation.