Linked Life Data

10567956

Source:http://linkedlifedata.com/resource/pubmed/id/10567956

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pubmed-article:10567956pubmed:abstractTextBasiliximab is an immunosuppressant chimeric monoclonal antibody directed to the human interleukin-2 receptor alpha-chain used for prevention of acute rejection episodes in organ transplantation. The minimally effective serum concentration necessary to saturate receptor epitopes in kidney transplant patients is 0.2 microgram/ml. To guide dose selection for Phase 3 efficacy trials, a population pharmacostatistical model was fitted to intensively sampled Phase 2 pharmacokinetic data. This served as a basis from which to examine candidate dose regimens with respect to the duration over which receptor-saturating concentrations would be achieved posttransplant. Three prediction methods were assessed: one based on simulations, and two others based on first-order approximation using either inverse regression or inversion of confidence intervals. An 80% prediction interval was generated by each method to evaluate its predictive performance against prospectively collected Phase 3 data in 39 renal transplant patients who received two injections of 20 mg basiliximab, one prior to surgery and one on Day 4 posttransplant. All methods provided correct prediction of the duration of receptor-saturating concentration. As anticipated, the best performance was obtained from the simulation method which predicted 30 values in the 80% prediction interval, 19.7-52.7 days. The actually observed 80% interval from the Phase 3 data was 23.7-58.3 days.lld:pubmed
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pubmed-article:10567956pubmed:dateRevised2005-11-17lld:pubmed
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pubmed-article:10567956pubmed:articleTitleConstructing a prediction interval for time to reach a threshold concentration based on a population pharmacokinetic analysis: an application to basiliximab in renal transplantation.lld:pubmed
pubmed-article:10567956pubmed:affiliationINSERM U436, Paris, France.lld:pubmed
pubmed-article:10567956pubmed:publicationTypeJournal Articlelld:pubmed
pubmed-article:10567956pubmed:publicationTypeClinical Triallld:pubmed
pubmed-article:10567956pubmed:publicationTypeRandomized Controlled Triallld:pubmed
pubmed-article:10567956pubmed:publicationTypeClinical Trial, Phase IIlld:pubmed
pubmed-article:10567956pubmed:publicationTypeClinical Trial, Phase IIIlld:pubmed