Population Pharmacokinetics and Pharmacokinetic-Pharmacodynamic Relationships for Docetaxel
作者： René Bruno , Nicole Vivier , Christine Veyrat-Follet , Guy Montay , Gerald R. Rhodes
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摘要: The population approach has been implemented prospectively in the clinical development of docetaxel (Taxotere). Overall 640 patients were evaluable for PK/PD analysis. PK analysis evidenced significant covariates explaining inter-patient variability clearance and demonstrated that was a predictor several safety endpoints. In with chemistry suggestive mild to moderate liver function impairment (SGOT and/or SGPT > 1.5 x ULN concomitant alkaline phosphatase >2.5 ULN), total body lowered by an average 27%. Specific analyses these are at significantly higher risk than others severe docetaxel-induced side effects. Population data fully integrated into regulatory dossier labeling worldwide. models being used elaborate simulation model predict survival non-small cell lung cancer treated docetaxel.
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