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

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 topical...

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Bibliographic Details
Published in:	Dermatology and therapy Vol. 14; no. 8; pp. 2153 - 2169
Main Authors:	Eichner, Adina, Mrestani, Yahya, Hukauf, Martin, Wohlrab, Johannes
Format:	Journal Article
Language:	English
Published:	Cheshire Springer Healthcare 01-08-2024 Springer Adis, Springer Healthcare
Subjects:	Comparative analysis Dermatology EMA draft guideline on quality and equivalence of topical products Generic drugs Health aspects In vitro penetration test (IVPT) Internal Medicine Medicine Medicine & Public Health Mometasone Mometasone furoate Oral and Maxillofacial Surgery Original Research Plastic Surgery Product introduction Quality management Quality of Life Research Skin Topical bioequivalence Topical medication Germany In vitro penetration test (IVPT) Mometasone furoate EMA draft guideline on quality and equivalence of topical products Topical bioequivalence
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