Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission

Autor: Barbara M. Davit, Paulo Paixão, A. Garcia-Arieta, Jean-Michel Cardot, I. Tasevska
Přispěvatelé: Microbiologie Environnement Digestif Santé (MEDIS), INRA Clermont-Ferrand-Theix-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Agencia Española de Medicamentos y Productos Sanitarios, Partenaires INRAE, Instituto Nacional da Farmácia e do Medicamento, State Institute for Drug Control, Merck, Sharp and Dohme Corp, Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: European Journal of Pharmaceutical Sciences
European Journal of Pharmaceutical Sciences, Elsevier, 2018, 111, pp.399-408. ⟨10.1016/j.ejps.2017.10.013⟩
European Journal of Pharmaceutical Sciences, 2018, 111, pp.399-408. ⟨10.1016/j.ejps.2017.10.013⟩
ISSN: 0928-0987
1879-0720
Popis: International audience; This review describes the EMA requirements on biowaivers for additional strengths of immediate release and modified release oral solid dosage forms focused on generic applications and highlights the challenges for a simultaneous EMA and FDA submission. Some specificities of the current EMA guidelines are compared with the current FDA Guidance for Industry, with a special focus on the strength to be investigated in vivo, formulation suitability for biowaiver, and optimizing dissolution studies for additional strength biowaivers. In Europe, the same principles applied for generics may be considered for deriving the biowaivers for innovator products. Several case studies are presented to illustrate the challenges of applying for additional strength biowaivers in EMA and FDA simultaneously.
Databáze: OpenAIRE
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