535-0360-00L Evidence Based Phytotherapy
Semester | Autumn Semester 2018 |
Lecturers | J. Drewe, K. Berger Büter |
Periodicity | yearly recurring course |
Language of instruction | German |
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) 19.09.2018 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) 26.09.2019 Grundlegende Begriffe der evidenzbasierten Medizin Hypericum perforatum (inklusive Pyrrolizidinalkaloid Problematik 03.10.2018 Rhodiola rosea Lavendelöl 10.10.2018 Pelargonium Echinacea 17.10.2018 Petasites (inklusive Pyrrolizidinalkaloid-Problematik) 24.10.2017 Cimicifuga Silybum marianum 31.10.2018 Iberogast® Prüfung (MC) |
Lecture notes | Die Skripten werden vor den jeweiligen Vorlesungen per Email an die Teilnehmer versandt |