Sirolimus: has it gained from experience with older drugs?
The immunosuppressive drug sirolimus, recently licensed in Europe for use following kidney transplantation, was developed against a background in which it was common practice to use blood concentration measurements as a guide to therapy. This article sets out to document the use of blood concentration measurements in the assessment of the early and pivotal clinical trials of the drug and the attention that has been paid to the validation of analytical techniques used to measure the drug. It is concluded that, building on experience from the older drugs used for immunosuppression, data relating drug concentrations with efficacy outcomes have played a significant role in formulating guidelines on sirolimus dosing.
Analytical Unit, St George's Hospital Medical School, London, UK. d.holt@sghms.ac.uk
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D002853:Chromatography, Liquid / Q000379:methods; D016903:Drug Monitoring / Q000379:methods; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D016030:Kidney Transplantation; D020123:Sirolimus / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics
D007166:Immunosuppressive Agents; D020123:Sirolimus