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Development of a limited sampling strategy for pharmacokinetic studies with pemetrexed.








Development of a limited sampling strategy for pharmacokinetic studies with pemetrexed.


Rob ter Heine


Radboud University Medical Center






25 September 2018


Pemetrexed is an important first line anticancer drug for treatment of non-small cell lung cancer and mesothelioma. We aim to perform minimally invasive pharmacokinetic studies with pemetrexed. To allow for a minimal invasive sampling strategy, we aim to develop a limited sampling strategy (LSS). Rich pharmacokinetic data, as obtained during drug development, is needed for the external validation of an LSS. For this purpose, we are requesting the clinical pharmacokinetic data of pemetrexed.



[{ "PostingID": 3864, "Title": "LILLY-H3E-MC-JMAS", "Description": "A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer" },{ "PostingID": 3865, "Title": "LILLY-H3E-MC-JMAW", "Description": "A Phase 1 Pharmacokinetic Trial of LY231514 Administered Intravenously Every 3 Weeks in Advanced Cancer Patients with Varying Degrees of Renal Function" }]

Statistical Analysis Plan