Evidence Based Phytotherapy

Abstract

Based on epidemiology, economic importance and evidence-based medicine, basic principles of rational phytotherapy will be discussed: a) Identification of drug candidates, b) registration requirements, c) criteria to assess efficacy, d) biomarkers and pharmacokinetics, e) safety and f) principles of extract generation. Important prototypes will be discussed

Objective

Students should learn the importance of rational (= evidence based) pharmacotherapy with herbal extracts: They should get to know the development process of herbal drugs: o How are interesting development candidates are being identified? What are the strategies? o What are the regulatory requirements (traditional use, well-established use, new herbal entities)? o What are the selection criteria? o Assessment of efficacy (animal-/human studies, biomarker) o Pharmacokinetics o Safety (Toxicity, unwanted adverse effects, drug-drug interactions) o Pharmaceutical quality o Securing of herbal identity (collections, agriculture) o Quality management o selection of appropriate extraction procedures? Important prototy pes will be presented and critically discussed: see prgram below

Content

Effektive Zeiten 15.45 - 16.30; 16.45-17.30) 1) 22.09.2021 Einführung Qualität Arzneipflanzen-Fertigprodukte, Monographien (Kommission E, ESCOP, HMPC), Unterschiede hinsichtlich des Registrierungsstatus und -anforderungen: traditional use, well established use und new herbal entities; Extrakte, Qualität Arzneidrogen 2) 29.9.2021: Phasen der klinischen Entwicklung, Grundbegriffe der evidenzbasierten Medizin; Hypericum perforatum 3) 06.10.2020: Harpagophytum spp.; Echinacea ssp 4) 13.10.2020: Lavandula oelum; Iberogast 5) 20.10.2020: Cimicifuga racemosa; Serenoa repens 6) 27.10.2020: Silybum marianum; Cannabis sativa 7) 03.11.2020 Prüfung (MC)

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