Regulatory and safe-use considerations related to stability after opening of nonsterile dosage forms-Reference-Cited by-同舟云学术

Regulatory and safe-use considerations related to stability after opening of nonsterile dosage forms

Published:2022-03-07 Issue:3 Volume:52 Page:319-329
ISSN:2093-5552
Container-title:Journal of Pharmaceutical Investigation
language:en
Short-container-title:J. Pharm. Investig.

Author:

Lee Haesoo,Jin Minki,Jeon Woo-Jin,Kim Haeun,Jung Minwoo,Yoo Hyelim,Won Jong-Hee,Cho Cheong-Weon

Funder

National Institute of Food and Drug Safety Evaluation

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology, Toxicology and Pharmaceutics (miscellaneous),Pharmaceutical Science

Link

https://link.springer.com/content/pdf/10.1007/s40005-022-00564-0.pdf

Reference35 articles.

1. American Society of Health-System Pharmacists (1994) ASHP Technical Assistance Bulletin on Compounding Nonsterile Products in Pharmacies. Am J Health Syst Pharm 1994(51):1441–1448

2. European Medicines Agency (1998) Note for guidance on development pharmaceutics

3. European Medicines Agency (2001) Note for Guidance on In-use stability Testing of Human Medicinal Products

4. European Medicines Agency (2003) Note for guidance on stability testing: Stability testing of new drug substances and products

5. European Medicines Agency (2004) Guideline on stability testing: Stability testing of existing active substances and related finished products

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