1 / 9

Artemisia & Malaria

Artemisia & Malaria. Presented By Tom Chapman M.R.PharmS Essential Nutrition, Brough, United Kingdom. Artemisia : A History. Over 2000 years of documented history for treating fevers in China. 1972 Artemisinin isolated in China. 1982 Antimalarial activity reported (BMJ).

tevy
Télécharger la présentation

Artemisia & Malaria

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Artemisia & Malaria Presented By Tom Chapman M.R.PharmS Essential Nutrition, Brough, United Kingdom

  2. 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).

  3. Problems In Producing Artemisinin • Low yeilds. Overcome by selection – Rutgers (Jim Simon). • Growing and harvesting. • Drying. • Extraction. • Conversion to GMP product – Macfarlane Smith

  4. Problems In Producing Finished Products • Local manufacture – GMP certificate. • Pack design & languages. • Registration locally. • Clinical trials. • Registration fees. • Time.

  5. The Market • WHO – Combination Products. • WHO – Not For Prophylaxis

  6. Why License Anyway ? • Product liability insurance. • Batch recall procedure. • Pharmacovigilance. • Adverse events reporting. • Unable to export.

  7. 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?

  8. 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.

  9. 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.

More Related