Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions Blog Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions Analogous to how a geologist surveys the “lay of the land” to determine if oil…CertaraFebruary 16, 2018
Model-informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor Publication Model-informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor CertaraFebruary 15, 2018
Prediction of Olanzapine Exposure in Individual Patients Using Physiologically-based Pharmacokinetic Modeling and Simulation Publication Prediction of Olanzapine Exposure in Individual Patients Using Physiologically-based Pharmacokinetic Modeling and Simulation CertaraNovember 30, 2017
Exposure-response of Veliparib to Inform Phase 2 Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Publication Exposure-response of Veliparib to Inform Phase 2 Trial Design in Refractory or Relapsed Patients with Hematological Malignancies CertaraNovember 1, 2017
Clinical Pharmacology Tools and Evaluations to Facilitate Comprehensive Dose Finding in Oncology: A Continuous Risk-Benefit Approach Publication Clinical Pharmacology Tools and Evaluations to Facilitate Comprehensive Dose Finding in Oncology: A Continuous Risk-Benefit Approach CertaraSeptember 15, 2017
Parent‐metabolite Pharmacokinetic Modeling and Pharmacodynamics of Veliparib (ABT‐888), a PARP Inhibitor, in Patients with BRCA 1/2–mutated Cancer or PARP‐sensitive Tumor Types Publication Parent‐metabolite Pharmacokinetic Modeling and Pharmacodynamics of Veliparib (ABT‐888), a PARP Inhibitor, in Patients with BRCA 1/2–mutated Cancer or PARP‐sensitive Tumor Types CertaraAugust 1, 2017
Response Analysis of Alvocidib (Flavopiridol) Treatment by Bolus or Hybrid Administration in Newly Diagnosed or Relapsed/Refractory Acute Leukemia Patients Publication Response Analysis of Alvocidib (Flavopiridol) Treatment by Bolus or Hybrid Administration in Newly Diagnosed or Relapsed/Refractory Acute Leukemia Patients CertaraJuly 15, 2017
Predicting Diclofenac Systemic and Synovial Fluid Concentrations After Dermal Application Using the Multi-phase Multi-layer MechDermA PBPK Model Poster Predicting Diclofenac Systemic and Synovial Fluid Concentrations After Dermal Application Using the Multi-phase Multi-layer MechDermA PBPK Model CertaraJune 6, 2017
Time Dependent Pharmacokinetics of Pembrolizumab in Patients with Solid Tumor and Its Correlation with Best Overall Response Publication Time Dependent Pharmacokinetics of Pembrolizumab in Patients with Solid Tumor and Its Correlation with Best Overall Response CertaraJune 1, 2017
Obeticholic Acid—From PK Model to Drug Label On-Demand Webinar Obeticholic Acid—From PK Model to Drug Label Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to…CertaraJune 1, 2017