Author:
Lex Timothy R.,Rodriguez Jason D.,Zhang Lei,Jiang Wenlei,Gao Zongming
Publisher
Springer Science and Business Media LLC
Reference147 articles.
1. CDER. Assessing the effects of food on drugs in INDs and NDAs — clinical pharmacology considerations guidance for industry. 2019.
2. Chen ML, Blume H, Beuerle G, Davit B, Mehta M, Potthast H, et al. The Global Bioequivalence Harmonization Initiative: summary report for EUFEPS international conference. Eur J Pharm Sci. 2018;111:153–7.
3. CDER. M9 Biopharmaceutics Classification System-Based Biowaivers. 2021.
4. Malinowski H, Marroum P, Uppoor VR, Gillespie W, Ahn HY, Lockwood P, et al. Draft guidance for industry extended-release solid oral dosage forms. Development, evaluation and application of in vitro-in vivo correlations. Adv Exp Med Biol. 1997;423:269–88.
5. ICH. Final Concept Paper M13: Bioequivalence for immediate-release solid oral dosage forms 2020.
Cited by
15 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献