535-0360-00L  Evidence Based Phytotherapy

SemesterAutumn Semester 2021
LecturersK. Berger Büter
Periodicityyearly recurring course
Language of instructionGerman


AbstractBased 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
Learning objectiveStudents 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
ContentEffektive 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)
Lecture notesDie Skripten werden vor den jeweiligen Vorlesungen per Email an die TeilnehmerInnen versandt