Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements
Author:
Publisher
Elsevier BV
Subject
Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology
Reference2 articles.
1. 16th international conference of drug regulatory authorities (ICDRA) and its recommendations;WHO Drug Inf,2014
2. WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27–28 April 2017;Biologicals,2018
Cited by 2 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. Biosimilars: evolution of approaches to the development, regulation, life cycle control and interchangeability management;Remedium;2021-12-01
2. WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25–26 June 2019;Biologicals;2020-05
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