Výsledky vyhledávání - "Sada L. Turimella"

Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019

Autor: Alex Zwiers, Sada L. Turimella, Frans Metsers, Judith P. ter Horst

Publikováno v: Therapeutic Innovation & Regulatory Science

Background Quality by Design (QbD) is a systematic risk-based approach to development, with predefined characteristics and quality risk management throughout the life cycle of a product. International Conference on Harmonization (ICH) guidelines Q8�

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::421fec2b85704858eda38b3d96a694ce
http://europepmc.org/articles/PMC8021511

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