Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) for analytical procedure development of related substances in tenofovir alafenamide fumarate tablets

Author:

Teng Jianhao,Zhu Chunmei,Lyu Jinyuan,Pan Linyu,Zhang Meng,Zhang Fuli,Wu Haoxiang

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference35 articles.

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4. VEKLURY (remdesivir) Approval Letter(s), Center for Drug Evaluation and Research, October 22, 2020. 〈https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000Approv.pdf〉 (Accessed 10 March 2021).

5. SOVALDI (sofosbuvir) Tablet Approval Letter(s), Center for Drug Evaluation and Research, December 06, 2013. 〈https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000Approv.pdf〉 (Accessed 10 March 2021).

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