Quality by design (QbD) approach in marketing authorization procedures of Non-Biological Complex Drugs: A critical evaluation-Reference-Cited by-同舟云学术

Quality by design (QbD) approach in marketing authorization procedures of Non-Biological Complex Drugs: A critical evaluation

Published:2022-09 Issue: Volume:178 Page:1-24
ISSN:0939-6411
Container-title:European Journal of Pharmaceutics and Biopharmaceutics
language:en
Short-container-title:European Journal of Pharmaceutics and Biopharmaceutics

Author:

Zagalo Daniela M.,Sousa João,Simões Sérgio

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference188 articles.

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3. Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey;Oner;Ann. N. Y. Acad. Sci.,2017

4. Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation;Lunawat;Ther. Innov. Regul. Sci.,2020

5. The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations;Klein;Eur. J. Pharm. Sci.,2019

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