Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products
Joint Authors
Choi, Goya
Lee, Kyungjin
Jerng, Ui Min
Kim, Jung Hoon
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2019, Issue 2019 (31 Dec. 2019), pp.1-14, 14 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2019-10-20
Country of Publication
Egypt
No. of Pages
14
Main Subjects
Abstract EN
Quality consistencies of drug products are essential to guarantee expected therapeutic activities, and achieving consistent qualities for herbal products is challenging because of their physicochemical complexities and inherent variabilities.
Regulatory authorities worldwide have issued regulations or guidelines for stability testing parameters and testing procedures for herbal products stored in proposed conditions.
These testing parameters and methods for finished herbal products are detailed in the guidelines and regulations issued by 5 global authorities and 15 countries, that is, the Association of Southeast Asian Nations (ASEAN), the Eurasian Economic Commission (EEC), the European Medicines Agency (EMA), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the World Health Organization (WHO), Australia, Brazil, Canada, China, Egypt, Hong Kong, India, Japan, Kenya, Republic of Korea, the Philippines, Qatar, Switzerland, USA, and Zambia.
Physical, chemical, and biological stability tests were compared between different dosage forms, and the testing conditions (temperature and relative humidity) used for long-term, accelerated, or intermediate testing were included in the guidelines and regulations.
Comparisons of global regulations and guidelines addressing stability testing are fundamental for the international harmonization of herbal product quality assessments.
This review aids understanding of the global situation regarding the testing of herbal product quality with respect to storages.
American Psychological Association (APA)
Kim, Jung Hoon& Lee, Kyungjin& Jerng, Ui Min& Choi, Goya. 2019. Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products. Evidence-Based Complementary and Alternative Medicine،Vol. 2019, no. 2019, pp.1-14.
https://search.emarefa.net/detail/BIM-1150816
Modern Language Association (MLA)
Kim, Jung Hoon…[et al.]. Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products. Evidence-Based Complementary and Alternative Medicine No. 2019 (2019), pp.1-14.
https://search.emarefa.net/detail/BIM-1150816
American Medical Association (AMA)
Kim, Jung Hoon& Lee, Kyungjin& Jerng, Ui Min& Choi, Goya. Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products. Evidence-Based Complementary and Alternative Medicine. 2019. Vol. 2019, no. 2019, pp.1-14.
https://search.emarefa.net/detail/BIM-1150816
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1150816