Modeling and Simulation - PK/PD Archives | Page 26 of 38

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

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

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

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

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

Modeling and Simulation – PK/PD

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

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

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

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

Brain Extracellular γ-hydroxybutyrate Concentrations are Decreased by L-lactate in Rats: Role in the Treatment of Overdoses

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