Therapeutic Specialties Archives

Publication

Prediction of Overall Survival or Progression Free Survival by Disease Control Rate at Week 8 Is Independent of Ethnicity: Western Versus Chinese Patients with First-line Non-small Cell Lung Cancer Treated with Chemotherapy with or without Bevacizumab

Categorizations of best response observed at week 8 of first-line treatment in two studies of…

CertaraOctober 22, 2013

Publication

Differential Pharmacokinetics of Ganitumab in Patients with Metastatic Pancreatic Cancer Versus Other Advanced Solid Cancers

Ganitumab is an investigational, fully human monoclonal antibody antagonist of the insulin-like growth factor-1 receptor…

CertaraOctober 1, 2013

Publication

Exposure-response Analysis of Pertuzumab in HER2-positive Metastatic Breast Cancer: Absence of Effect on QTc Prolongation and Other ECG Parameters

The phase III trial of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus…

CertaraSeptember 3, 2013

Publication

Using Historical Control Information for the Design and Analysis of Clinical Trials with Overdispersed Count Data

Results from clinical trials are never interpreted in isolation. Previous studies in a similar setting…

CertaraSeptember 1, 2013

Publication

Siponimod for Patients with Relapsing-remitting Multiple Sclerosis (BOLD): An Adaptive, Dose-ranging, Randomized, Phase 2 Study

Siponimod is an oral selective modulator of sphingosine 1-phosphate receptor types 1 and type 5,…

CertaraSeptember 1, 2013

Publication

A Pilot Study Assessing the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration in Healthy Volunteers

Diazepam rectal gel (Diastat®) is the only FDA-approved product indicated for acute repetitive seizures. Despite…

CertaraAugust 1, 2013

Publication

Age Related Changes in Fractional Elimination Pathways for Drugs: Assessing the Impact of Variable Ontogeny on Metabolic Drug-drug Interactions

The magnitude of any metabolic drug-drug interactions (DDIs) depends on fractional importance of inhibited pathway…

CertaraMay 30, 2013

Publication

Biodistribution and Pharmacokinetics of EGFR-targeted Thiolated Gelatin Nanoparticles Following Systemic Administration in Pancreatic Tumor-bearing Mice

The objective of this study was to evaluate qualitative and quantitative biodistribution of epidermal growth…

CertaraMay 6, 2013

Publication

Brain Extracellular γ-hydroxybutyrate Concentrations are Decreased by L-lactate in Rats: Role in the Treatment of Overdoses

L-lactate represents a potential treatment for GHB overdose by inhibiting GHB renal reabsorption mediated by…

CertaraMay 1, 2013

Publication

Do Children Have the Same Vulnerability to Metabolic Drug-drug Interactions as Adults? A Critical Analysis of the Literature

Many drug–drug interactions (DDIs) in the pediatric population are managed based on data generated in…

CertaraMay 1, 2013

Therapeutic Specialties

Prediction of Overall Survival or Progression Free Survival by Disease Control Rate at Week 8 Is Independent of Ethnicity: Western Versus Chinese Patients with First-line Non-small Cell Lung Cancer Treated with Chemotherapy with or without Bevacizumab

Differential Pharmacokinetics of Ganitumab in Patients with Metastatic Pancreatic Cancer Versus Other Advanced Solid Cancers

Exposure-response Analysis of Pertuzumab in HER2-positive Metastatic Breast Cancer: Absence of Effect on QTc Prolongation and Other ECG Parameters

Using Historical Control Information for the Design and Analysis of Clinical Trials with Overdispersed Count Data

Siponimod for Patients with Relapsing-remitting Multiple Sclerosis (BOLD): An Adaptive, Dose-ranging, Randomized, Phase 2 Study

A Pilot Study Assessing the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration in Healthy Volunteers

Age Related Changes in Fractional Elimination Pathways for Drugs: Assessing the Impact of Variable Ontogeny on Metabolic Drug-drug Interactions

Biodistribution and Pharmacokinetics of EGFR-targeted Thiolated Gelatin Nanoparticles Following Systemic Administration in Pancreatic Tumor-bearing Mice

Brain Extracellular γ-hydroxybutyrate Concentrations are Decreased by L-lactate in Rats: Role in the Treatment of Overdoses

Do Children Have the Same Vulnerability to Metabolic Drug-drug Interactions as Adults? A Critical Analysis of the Literature

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