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: Hypericum perforatum Rhodiola rosea Lavendelöl Pelargonium Echinacea Petasites Cimicifuga Silybum marianum Iberogast®

Content

Effektive Zeiten 14.45 - 15.30; 15.45-16.30) 16.09.2020 Qualität Arzneipflanzen-Fertigprodukte, Monographien (Kommission E, ESCOP, HMPC), Unterschiede hinsichtlich des Registrierungsstatus und -anforderungen: traditional use, well established use und new herbal entities, Methoden Produktentwicklung (Pflanzenauswahl, Anbau, Extraktentwicklung, präklinische und klinische Entwicklung) 23.9.2020 Pelargonium ssp. Echinacea ssp. 30.9.2020 Hypericum perforatum Grundlegende Begriffe der evidenzbasierten Medizin 7.10.2020 Rhodiola rosea Lavandula oelum 14.10.2020 Petasites (inklusive Pyrrolizidinalkaloid-Problematik) Iberogast 21.10.2020 Cimicifuga racemosa Silybum marianum 28.10.2020 Cannabis sativa Prüfung (MC)

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