Author:
Doneski Leon,Dong Michael
Abstract
The pharmaceutical industry develops and manufactures life-saving medicines and is regulated by government authorities to ensure drug products’ safety, efficacy, and quality before reaching patients. This article provides a high-level overview of pharmaceutical regulations and associated public quality standards.
Publisher
Multimedia Pharma Sciences, LLC
Reference21 articles.
1. Hill, R. G.; Rang H.P. (Eds). Drug Discovery and Development: Technology in Transition, 2nd ed., Churchill Livingston, Elsevier, 2012.
2. Ali, J.; Baboota, S. (Eds.) Regulatory Affairs in the Pharmaceutical Industry, 1st Edition, Academic Press, 2021.
3. Dong, M.W. HPLC and UHPLC for Practicing Scientists, 2nd Ed., Wiley, 2019, pp 221–243, 281-303.
4. Sarker, D. K. Quality Systems and Controls for Pharmaceuticals, Wiley, 2008.
5. Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report, US FDA, 2007, https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/pharmaceutical-quality-21st-century-risk-based-approach-progress-report (accessed 2023-04-18)
Cited by
3 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