pre-update Archives

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

A Randomised Study of the Effect of Danoprevir/Ritonavir or Ritonavir on Substrates of Cytochrome P450 (CYP) 3A and 2C9 in Chronic Hepatitis C Patients Using a Drug Cocktail

CertaraJuly 20, 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

Intravenous Topiramate: Safety and Pharmacokinetics Following a Single Dose in Patients with Epilepsy or Migraines Taking Oral Topiramate

Although topiramate is widely prescribed for epilepsy and migraine, there is no intravenous product. We…

CertaraJune 1, 2013

Publication

Intravenous Topiramate: Comparison of Pharmacokinetics and Safety with the Oral Formulation in Healthy Volunteers

Although oral topiramate (TPM) products are widely prescribed for migraines and epilepsy, injectable TPM is not available…

CertaraJune 1, 2013

Publication

Application of In Vitro-In Vivo Extrapolation (IVIVE) and Physiologically-based Pharmacokinetic Modeling to Investigate the Impact of the CYP2C8 Polymorphism on Rosiglitazone Exposure

The purpose of this study was to predict the impact of the CYP2C8*3 genotype on…

CertaraJune 1, 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

pre-update

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

A Randomised Study of the Effect of Danoprevir/Ritonavir or Ritonavir on Substrates of Cytochrome P450 (CYP) 3A and 2C9 in Chronic Hepatitis C Patients Using a Drug Cocktail

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

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

Intravenous Topiramate: Safety and Pharmacokinetics Following a Single Dose in Patients with Epilepsy or Migraines Taking Oral Topiramate

Intravenous Topiramate: Comparison of Pharmacokinetics and Safety with the Oral Formulation in Healthy Volunteers

Application of In Vitro-In Vivo Extrapolation (IVIVE) and Physiologically-based Pharmacokinetic Modeling to Investigate the Impact of the CYP2C8 Polymorphism on Rosiglitazone Exposure

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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