Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
https://link.springer.com/content/pdf/10.1208/s12248-023-00837-y.pdf
Reference50 articles.
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3. Zhang L, Mao S. Application of quality by design in the current drug development. Asian J Pharm Sci. 2017;12(1):1–8. https://doi.org/10.1016/j.ajps.2016.07.006.
4. Guidance for industry. Q10: pharmaceutical quality system. 2009. https://www.fda.gov/media/71553/download. Accessed 02nd Apr 2023.
5. Flanagan T, Peer AV, Lindahl A. Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: where are we now and what are the gaps? Eur J Pharm Sci. 2016;91:84–90. https://doi.org/10.1016/j.ejps.2016.06.006.
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