Population PK & Dosing Implications for Cobimetinib in Cancer Patients
A population pharmacokinetic model was developed for cobimetinib in cancer patients. Covariates had minimal impact…
CertaraNovember 1, 2015
Pharmacokinetics of Tramadol and O-Desmethyltramadol Enantiomers Following Administration of Extended-release Tablets to Elderly and Young Subjects
Tramadol is frequently used in geriatric patients; however, pharmacokinetic (PK) publications on tramadol and O-desmethyltramadol…
CertaraOctober 27, 2015
Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients
The published OS model and resultant simulations can be leveraged to support Phase II design…
CertaraSeptember 1, 2015
Population Pharmacokinetic Modeling of Motesanib and Its Active Metabolite, M4, in Cancer Patients
Motesanib is a small molecule and potent multikinase inhibitor with antiangiogenic and antitumor activity. Population…
CertaraJuly 23, 2015
Prediction of Voriconazole Non-linear Pharmacokinetics Using a Pediatric Physiologically-based Pharmacokinetic Modeling Approach
We read with interest the report by Zane and Thakker entitled ‘‘A PBPK model for…
CertaraMay 1, 2015
Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment
Thrombomodulin alfa is a soluble recombinant human thrombomodulin that was reported to enhance the reversal…
CertaraMay 1, 2015
Does Age Affect Gastric Emptying Time? A Model-based Meta-analysis
Gastric emptying (GE) is often reported to be slower and more irregular in premature neonates than…
CertaraMay 1, 2015
Pediatric Drug Dosing: Tackling Big Problems for Little Patients
The challenges and complexities of pediatric drug development are well recognized. Pharmacometric modeling and simulation (M&S)…
CertaraApril 23, 2015
Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9
RG7652 is a fully humanized monoclonal antibody targeting human PCSK9, a regulator of serum low…
CertaraMarch 31, 2015
