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
A Model-based Dose-response Meta-analysis of Ocular Hypotensive Agents as a Drug Development Tool to Evaluate New Therapies in Glaucoma Publication A Model-based Dose-response Meta-analysis of Ocular Hypotensive Agents as a Drug Development Tool to Evaluate New Therapies in Glaucoma PURPOSE: To characterize dose and response for intraocular pressure (IOP) reduction and incidence of hyperemia…CertaraMay 1, 2015
Month 2 Culture Status and Treatment Duration as Predictors of Recurrence in Pulmonary Tuberculosis: Model Validation and Update Publication Month 2 Culture Status and Treatment Duration as Predictors of Recurrence in Pulmonary Tuberculosis: Model Validation and Update New regimens capable of shortening tuberculosis treatment without increasing the risk of recurrence are urgently…CertaraApril 29, 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
Pharmacokinetics and Safety of Oseltamivir in Patients with End-stage Renal Disease Treated with Automated Peritoneal Dialysis Publication Pharmacokinetics and Safety of Oseltamivir in Patients with End-stage Renal Disease Treated with Automated Peritoneal Dialysis CertaraMarch 25, 2015
Chemotherapy of Second Stage Human African Trypanosomiasis: Comparison Between the Parenteral Diamidine DB829 and Its Oral Prodrug DB868 in Vervet Monkeys Publication Chemotherapy of Second Stage Human African Trypanosomiasis: Comparison Between the Parenteral Diamidine DB829 and Its Oral Prodrug DB868 in Vervet Monkeys Human African trypanosomiasis (HAT, sleeping sickness) ranks among the most neglected tropical diseases based on…CertaraFebruary 15, 2015