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

Author:

Eichner AdinaORCID,Mrestani Yahya,Hukauf Martin,Wohlrab Johannes

Publisher

Springer Science and Business Media LLC

Reference16 articles.

1. European Medicines Agency (EMA). Concept paper on the development of product-specific guidance on demonstration of bioequivalence. 2013. https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-product-specific-guidance-demonstration-bioequivalence_en.pdf, Last accessed on 24 Jun 2024.

2. European Medicines Agency (EMA). Draft guideline on quality and equivalence of topical products. 2018. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-and-equivalence-topical-products_en.pdf, Last accessed on 24 Jun 2024.

3. Leal LB, et al. Bioequivalence methodologies for topical drug products: in vitro and ex vivo studies with a corticosteroid and an anti-fungal drug. Pharm Res. 2017;34(4):730–7.

4. Klein RR, et al. Development of an in vitro release test (IVRT) for a vaginal microbicide gel. Dissolut Technol. 2010;17:6–10.

5. Flaten GE, et al. In vitro skin models as a tool in optimization of drug formulation. Eur J Pharm Sci. 2015;75:10–24.

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