Creating and management of stability studies in AlkaSAP system
Author:
Affiliation:
1. Alkaloid AD Skopje, Blvd. Aleksandar Makedonski 12, 1000 Skopje, Republic of Macedonia
Publisher
Macedonian Pharmaceutical Association
Subject
General Medicine
Link
http://bulletin.mfd.org.mk/volumes/Volume%2068_3/68_3_059.pdf
Reference3 articles.
1. Bajaj, S., Singh, S., 2018. Methods for Stability Testing of Pharmaceuticals. Humana Press, 143-193. Available at: https://doi.org/10.1007/978-1-4939-7686-7_7
2. EudraLex, The Rules Governing Medicinal Products in the European Union, 2014. Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1, Chapter 6: Quality control. Available at: https://health.ec.europa.eu/system/files/2016-11/2014-11_vol4_chapter_6_0.pdf
3. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use; ICH guideline Q1A(R2) on Stability Testing of new Drug Substances and Products, 2003.Available at: https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf.
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