Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications-Reference-Cited by-同舟云学术

Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications

Published:2024-08-22 Issue:5 Volume:26 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Marden Stacey^ORCID,Campbell John M.,Adams Neal,Coelho Ronan,Foti Chris,Franca Juçara Ribeiro,Hostyn Steven,Huang Zongyun,Ultramari Mariah,Zelesky Todd,Baertschi Steven W.

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1208/s12248-024-00961-3.pdf

Reference42 articles.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Stability Testing of New Drug Substances and Products, Q1A(R2). ICH. 2003.

2. World Health Organization Annex 6: Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: Quality part. WHO Technical Report Series No 986. 2014.

3. Guideline for obtainment of the degradation profile, and identification and qualification of degradation products in drugs, Guideline No. 04/2015 – Version 1. In: ANVISA, editor. Brazilian Ministry of Health National Health Surveillance Agency 2015.

4. Baertschi SW, Pack BW, HoaglundHyzer CS, Nussbaum MA. Assessing mass balance in pharmaceutical drug products: New insights into an old topic. TrAC, Trends Anal Chem. 2013;49:126–36. https://doi.org/10.1016/j.trac.2013.06.006.

5. Nussbaum MA, Kaerner, A, Jansen, PJ, Baertschi SW. Role of “mass balance” in pharmaceutical stress testing. In: Baertschi SW, Alsante KM, Reed RA, editors. Pharmaceutical Stress Testing: Predicting Drug Degradation, 2nd ed: Informa Healthcare, London, UK; 2011. p. 233–53.