A comprehensive study on regulatory requirements for development and filing of generic drugs globally
Author:
Publisher
EManuscript Technologies
Subject
Pharmaceutical Science
Cited by 41 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
1. An Empirical Study on Generic Medicine and Branded Medicine;International Journal of Advanced Research in Science, Communication and Technology;2024-04-25
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3. Definições e escopo dos elementos-chave do Analytical Quality by Design (AQbD) para o desenvolvimento de métodos na indústria farmacêutica;Vigilância Sanitária em Debate;2023-10-05
4. Common chemistry, manufacturing, and control deficiencies in abbreviated new drug applications assessed by the US Food and drug administration: Hurdle to access cost-effective medicines;Journal of Pharmacological and Toxicological Methods;2023-09
5. Bridging the Gap: Aligning GMP Requirements for Generic Manufacturing across the US, EU and Japan;International Journal of Pharmaceutical Investigation;2023-07-08
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