Model Informed Drug Development Archives

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

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

Model-based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

The pharmaceutical industry continues to face significant challenges. Very few compounds that enter development reach…

CertaraJuly 1, 2013

Publication

The Simcyp Population-based Simulator: Architecture, Implementation, and Quality Assurance

Developing a user-friendly platform that can handle a vast number of complex physiologically based pharmacokinetic…

CertaraJune 3, 2013

Publication

Evaluation of an In Silico PBPK Postbariatric Surgery Model through Simulating Oral Drug Bioavailability of Atorvastatin and Cyclosporine

An increasing prevalence of morbid obesity has led to dramatic increases in the number of…

CertaraJune 1, 2013

Publication

Characterizing Systemic Exposure of Inhaled Drugs: Application to the Long-acting β2-agonist PF-00610355

PF-00610355 is an orally inhaled long-acting β2-adrenoreceptor agonist that is being developed for the once-daily…

CertaraJune 1, 2013

Model Informed Drug Development

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

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

Model-based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

The Simcyp Population-based Simulator: Architecture, Implementation, and Quality Assurance

Evaluation of an In Silico PBPK Postbariatric Surgery Model through Simulating Oral Drug Bioavailability of Atorvastatin and Cyclosporine

Characterizing Systemic Exposure of Inhaled Drugs: Application to the Long-acting β2-agonist PF-00610355

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