Therapeutic Specialties Archives

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

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

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

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

Publication

Study Reanalysis Using a Mechanism-based Pharmacokinetic/Pharmacodynamic Model of Pramlintide in Subjects with Type 1 Diabetes

This report describes a pharmacokinetic/pharmacodynamic model for pramlintide, an amylinomimetic, in type 1 diabetes mellitus…

CertaraJanuary 1, 2015

Publication

The Effect of Plasmapheresis on Blood Pressure in Voluntary Plasma Donors

Donor plasmapheresis involves the removal of a weight-adjusted volume of plasma and the return of…

CertaraJanuary 1, 2015

Publication

Population Dose-response Analysis of Daily Seizure Count Following Vigabatrin Therapy in Adult and Pediatric Patients with Refractory Complex Partial Seizures

Vigabatrin is an irreversible inhibitor of γ-aminobutyric acid transaminase (GABA-T) and is used as an…

CertaraJanuary 1, 2015

Publication

Onartuzumab with or without Bevacizumab in Combination with Weekly Paclitaxel Does Not Prolong QTc or Adversely Affect Other ECG Parameters in Patients with Locally Recurrent or Metastatic Triple-negative Breast Cancer

The purpose of this study was to examine the potential effect of onartuzumab, when administered…

CertaraDecember 17, 2014

Publication

Meropenem in Children Receiving Continuous Renal Replacement Therapy: Clinical Trial Simulations Using Realistic Covariates

Meropenem is frequently prescribed in children receiving continuous renal replacement therapy (CRRT). Fluid overload is…

CertaraDecember 1, 2014

Publication

Vigabatrin Pediatric Dosing Information for Refractory Complex Partial Seizures: Results from a Population Dose-response Analysis

We predicted vigabatrin dosages for adjunctive therapy for pediatric patients with refractory complex partial seizures…

CertaraDecember 1, 2014

Therapeutic Specialties

Does Age Affect Gastric Emptying Time? A Model-based Meta-analysis

Pediatric Drug Dosing: Tackling Big Problems for Little Patients

Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9

Chemotherapy of Second Stage Human African Trypanosomiasis: Comparison Between the Parenteral Diamidine DB829 and Its Oral Prodrug DB868 in Vervet Monkeys

Study Reanalysis Using a Mechanism-based Pharmacokinetic/Pharmacodynamic Model of Pramlintide in Subjects with Type 1 Diabetes

The Effect of Plasmapheresis on Blood Pressure in Voluntary Plasma Donors

Population Dose-response Analysis of Daily Seizure Count Following Vigabatrin Therapy in Adult and Pediatric Patients with Refractory Complex Partial Seizures

Onartuzumab with or without Bevacizumab in Combination with Weekly Paclitaxel Does Not Prolong QTc or Adversely Affect Other ECG Parameters in Patients with Locally Recurrent or Metastatic Triple-negative Breast Cancer

Meropenem in Children Receiving Continuous Renal Replacement Therapy: Clinical Trial Simulations Using Realistic Covariates

Vigabatrin Pediatric Dosing Information for Refractory Complex Partial Seizures: Results from a Population Dose-response Analysis

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