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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).

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Artemisia & Malaria

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  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.

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