|Title:||Contributions to regulation of herbal medicinal products from scientific institutions|
|Authors :||Wolfram, Evelyn|
|Proceedings:||Planta Medica International Open|
|Conference details:||65th International Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research (GA 2017), Basel, September 3 rd to 6th 2017|
|Publisher / Ed. Institution :||Thieme|
|Language :||Englisch / English|
|Subject (DDC) :||000: Allgemeines, Wissenschaft|
615: Pharmakologie und Therapeutik
|Abstract:||In contrast to mono-substance pharmaceuticals, the compliant assurance of quality, safety and efficacy of herbal medicinal products requires a much more complex and process oriented approach. The scope for standardization, relevant data acquisition and documentation starts on the field and in the natural habitats with Good Agricultural and Collection Practice (GACP) and not only later at the doors of a GMP certified factory. In addition to common physico-chemical identity testing, botanical aspects are assessed. In contrast to analytical quality control methods searching for peaks of known active pharmaceutical ingredient (API) molecules with a characteristic spectrum or molecular mass, the valid analysis of the multi-compound natural product mixture (herbal extract) as the API requires a multivariate and wider approach for standardization. The scientific institutions are capable to offer regulatory authorities and industry from a non-profit and independent position important competences and academic methodologies in assessment of e.g. API content, activity, toxicology and contaminants. Moreover, the academic sector provides education and training of professionals in the area of quality management, quality control methods and regulatory affairs. Special study and advanced study programs are in need for the herbal sector, to meet the demand of industry and authorities for competent staff within this special field. Selected case studies from own experience of collaboration with Swissmedic, EDQM and herbal medicinal industry of challenges in analytical method development for monographs and common technical documents (CTD) provide for hands-on insights about the current and potential value of the academic sector for regulation. Among other examples, the focus will be on HPTLC identification by flavonoid fingerprints and HPLC assay of anthraquinones and their aglycones in Senna leaves and pods.|
|Departement:||Life Sciences und Facility Management|
|Organisational Unit:||Institut für Chemie und Biotechnologie (ICBT)|
|Publication type:||Konferenz: Paper / Conference Paper|
|Appears in Collections:||Publikationen Life Sciences und Facility Management|
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