Therapeutic Specialties Archives

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

Publication

A Physiologically-based Pharmacokinetic (PBPK) Approach to Evaluate Pharmacokinetics in Patients with Cancer

Potential differences in pharmacokinetics (PK) between healthy subjects and patients with cancer were investigated using…

CertaraApril 1, 2013

Publication

Model-based Drug Development in Oncology: What’s Next?

Model-based estimates of tumor growth inhibition (TGI) metrics have the potential to enhance learning in…

CertaraApril 1, 2013

Publication

Model-supported Development of CS-8635: A Fixed-dose Combination of Olmesartan, Amlodipine, and Hydrochlorothiazide

CS-8635, a fixed-dose triple combination of olmesartan, amlodipine, and hydrochlorothiazide, was developed to address the…

CertaraApril 1, 2013

Therapeutic Specialties

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

A Physiologically-based Pharmacokinetic (PBPK) Approach to Evaluate Pharmacokinetics in Patients with Cancer

Model-based Drug Development in Oncology: What’s Next?

Model-supported Development of CS-8635: A Fixed-dose Combination of Olmesartan, Amlodipine, and Hydrochlorothiazide

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