Artemisia amp; Malaria课件.ppt

Artemisia Malaria Presented By Tom Chapman M.R.PharmS Essential Nutrition, Brough, United Kingdom 精品文档 Artemisia : A History Over 2000 years of documented history for treating fevers in China. 1972 Artemisinin isolated in China. 1982 Antimalarial activity reported (BMJ). 1982 Toxicity study reported (China Cooperative Research Group). 1985 Clinical trial data reported (Journal Of TCM). 1987 HPLC method for assay reported (XD LUO et al). 精品文档 Problems In Producing Artemisinin Low yeilds. Overcome by selection – Rutgers (Jim Simon). Growing and harvesting. Drying. Extraction. Conversion to GMP product – Macfarlane Smith 精品文档 Problems In Producing Finished Products Local manufacture – GMP certificate. Pack design languages. Registration locally. Clinical trials. Registration fees. Time. 精品文档 The Market WHO – Combination Products. WHO – Not For Prophylaxis 精品文档 Why License Anyway ? Product liability insurance. Batch recall procedure. Pharmacovigilance. Adverse events reporting. Unable to export. 精品文档 Why Are So Few Products Licensed? No profit incentive for large companies (exceptions). Too expensive for small companies. Which combinations to use? How many patients in clinical trials? Where do you register? How do you distribute finished products? 精品文档 A Theoretical Solution WHO / MMV Agree combinations. Procure clinical trial supplies. Clinical trial each combination. Register each product with FDA / EMEA. Hold product licence. Sub License Manufacture To Suitable 3rd Parties Who Can Show: Acceptable GMP certificate. Availability of GMP API. Suitable batch recall and pharmacovigilance. Produce GMP certificate with C of A. 精品文档 Benefits Of This System Jobs – Input for the country in both agriculture and manufacture. Export revenues and import substitution. Very good product. Good local distribution. Choice of antimalarial for that region. Good pharmacovigilance. Lower cost to produce. 精品文档