Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients Publication 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
Derivation for Logarithmic Trapezoidal AUC Calculation Knowledge Base Derivation for Logarithmic Trapezoidal AUC Calculation Calculating area under the curve requires the use of two separate equations: one is follows…CertaraAugust 5, 2015
Synthesis and Pharmacokinetic Evaluation of Siderophore Biosynthesis Inhibitors for Mycobacterium Tuberculosis Publication Synthesis and Pharmacokinetic Evaluation of Siderophore Biosynthesis Inhibitors for Mycobacterium Tuberculosis CertaraJuly 23, 2015
Population Pharmacokinetic Modeling of Motesanib and Its Active Metabolite, M4, in Cancer Patients Publication 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
Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment Publication 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 Publication 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 Blog 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
Effect of Age and Sex on the Pharmacokinetics and Safety of Avibactam in Healthy Volunteers Publication Effect of Age and Sex on the Pharmacokinetics and Safety of Avibactam in Healthy Volunteers Avibactam is a novel non-β-lactam β-lactamase inhibitor currently being assessed in combination with ceftazidime, ceftaroline…CertaraApril 1, 2015
Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 Publication 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
Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Avibactam Alone and in Combination with Ceftazidime in Healthy Male Volunteers: Results of Two Randomized, Placebo-controlled Studies Publication Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Avibactam Alone and in Combination with Ceftazidime in Healthy Male Volunteers: Results of Two Randomized, Placebo-controlled Studies Avibactam is a novel non-β-lactam β-lactamase inhibitor effective against Ambler class A, C and some…CertaraMarch 27, 2015