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
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
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
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
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
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
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
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
The Future of the Pharmaceutical Sciences and Graduate Education: Recommendations from the AACP Graduate Education Special Interest Group
Despite pharma's recent sea change in approach to drug discovery and development, U.S. pharmaceutical sciences…
CertaraMay 13, 2013
