Publication Archives

Publication

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin

Digoxin is the recommended substrate for assessment of P-glycoprotein (P-gp)-mediated drug-drug interactions (DDIs) in vivo.…

CertaraSeptember 1, 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

Accounting for Transporters in Renal Clearance: Towards a Mechanistic Kidney Model (Mech KiM)

The impact of transporters in modulating the disposition of drugs in the liver and their…

CertaraAugust 20, 2013

Publication

Temporal Profile of Lymphocyte Counts and Relationship with Infections with Fingolimod Therapy

Reduction in peripheral blood lymphocytes is an expected pharmacodynamic outcome of fingolimod therapy. The objective…

CertaraAugust 15, 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

Pharmacokinetic-pharmacodynamic Determinants of Oseltamivir Efficacy Using Data from Phase 2 Inoculation Studies

CertaraAugust 1, 2013

Publication

Basic Concepts in Physiologically-based Pharmacokinetic Modeling in Drug Discovery and Development

The aim of this tutorial is to introduce the concept of physiologically based pharmacokinetic (PBPK)…

CertaraAugust 1, 2013

Publication

Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-patient Study Designs in Psoriasis

Clinical trial simulation (CTS) and model-based meta-analysis (MBMA) can increase our understanding of small, first-in-patient…

CertaraJuly 24, 2013

Publication

A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine

The interplay between liver metabolizing enzymes and transporters is a complex process involving system-related parameters such as liver blood perfusion…

CertaraJuly 24, 2013

Publication

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin

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

Accounting for Transporters in Renal Clearance: Towards a Mechanistic Kidney Model (Mech KiM)

Temporal Profile of Lymphocyte Counts and Relationship with Infections with Fingolimod Therapy

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

Pharmacokinetic-pharmacodynamic Determinants of Oseltamivir Efficacy Using Data from Phase 2 Inoculation Studies

Basic Concepts in Physiologically-based Pharmacokinetic Modeling in Drug Discovery and Development

Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-patient Study Designs in Psoriasis

A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine

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