Discussion of EMA Draft Guideline on Quality and Equivalence of Topical Products Based on Comparison of Approved Mometasone Furoate Drugs

Abstract Introduction Today, the approval for a generic topical product includes the presentation of therapeutic equivalence to the originator based on clinical trials. To facilitate this procedure, in 2018 the European Medicines Agency (EMA) published a draft guideline on quality and equivalence of...

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Main Authors: Adina Eichner (Author), Yahya Mrestani (Author), Martin Hukauf (Author), Johannes Wohlrab (Author)
Format: Book
Published: Adis, Springer Healthcare, 2024-07-01T00:00:00Z.
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