The development and preparation of a quality control dossier for registration of Artemisia Afra capsules for the treatment of chronic Asthma by the South African health products regulatory authority
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Date
2018
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
University of the Western Cape
Abstract
The aim of this study was to determine quality control specifications needed for a dossier and an investigator's brochure of A. afra capsules, which can be used to motivate the registration and clinical testing of A. afra capsules in chronic asthma. The specific objectives were: (1) to establish the minimum product quality requirements for registration of A. afra capsules, (2) to prepare and pharmaceutically characterize a capsule product of A. afra freeze dried aqueous extract (FDAE) suitable for registration, and (3) to identify pharmaceutical product quality aspects of an investigator's brochure (IB) that would be appropriate for use in motivating a clinical trial of A. afra capsules in chronic asthma.
Description
Magister Pharmaceuticae - Mpharm
Keywords
Artemisia afra, Freeze dried aqueous extract, Quality control, Herbal capsules, South African Medicines Control Council / South African Health Products Regulatory Authority, Dossier, Investigational Drug Brochure