groups » Ask An Expert » Where and how to obtain investigational drug/placebo formulations - a novel use of chloroquine in Tanzania

Please can anyone help me with sourcing a company/pharmacy that can produce chloroquine and placebo capsules?

I require non-standard doses of CQ (3 different doses - each in a single capsule) and identical placebo capsules.

I cannot obtain these from within Tanzania as CQ has been de-registered due to its ban of use for treatment of malaria. My trial is testing another potential beneficial effect in children with sickle cell anaemia, although CQ remains national malaria prevention adn control policy for use in SCD patietns, although we have never been able to obtain chlorquine for our patients.

Thus i need to register CQ as an investigational drug wiht the Tanzanian Food and Drug authority and will need an investigators brochure etc.

Any help appreciated - i am running out of time before this is going to delay the start of the trial!

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investigational drug registration

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