Regulatory affairs for chemistry, manufacturing, and controls-Reference-Cited by-同舟云学术

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Regulatory affairs for chemistry, manufacturing, and controls

Published:2022 Issue: Volume: Page:75-87
ISSN:
Container-title:Regulatory Affairs in the Pharmaceutical Industry
language:
Short-container-title:

Author:

Gupta Sonal,Baboota Sanjula,Ali Javed,Dang Shweta

Publisher

Elsevier

Reference33 articles.

1. Chemistry, manufacturing and control (CMC) evaluations of ANDA submission in the USA;Akshatha;Ind. J. Pharm. Educ. Res.,2019

2. The essential principles of safety and effectiveness for medical devices and role of standards;Altayyar;Med. Devices (Auckl.),2020

3. Stability testing of pharmaceutical products;Bajaj;J. Appl. Pharm. Sci.,2012

4. Influence of (QbR) question based review to revamp CMC submission review;Balasubramanian;World J. Pharm. Med. Res.,2018

5. ICH guidelines – “Q” series (quality guidelines)—a review;Bhavyasri;GSC Biol. Pharm. Sci.,2019

Cited by 1 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. Artificial Intelligence in Drug Regulatory Submissions in India;Applied Drug Research, Clinical Trials and Regulatory Affairs;2022-04

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