Interdisciplinary Pharmacometrics Linking Oseltamivir Pharmacology, Influenza Epidemiology and Health Economics to Inform Antiviral Use in Pandemics
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Authors: Patrick Smith
Certara’s Best of Blogs 2016
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
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Quantitative Pharmacology Strategies for Pediatric Drug Development
Pediatric patients are not simply small adults. Children differ from adults in both disease pathophysiology and pharmacokinetics/pharmacodynamics (PK/PD). Yet historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. In this blog post, I’ll discuss the challenges of developing drugs for children and explain how quantitative pharmacology […]
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Clinical Pharmacology Strategy, PK/PD Modeling & SimulationEarly Development and Translational/Quantitative Pharmacology Strategies in Pediatric Drug Development
This seminar described the application of early development strategies to enable development in children, in cases where limited adult data are available. Extensive use of translational science and quantitative modeling and simulation methods are key underpinnings to facilitate the successful execution of these programs.
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Characterization of the Transmembrane Transport and Absolute Bioavailability of the HCV Protease Inhibitor Danoprevir
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Pharmacokinetics and Pharmacodynamics of Setrobuvir, an Orally Administered Hepatitis C Virus Non-nucleoside Analog Inhibitor
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A Pharmacokinetic/Viral Kinetic Model to Evaluate the Treatment Effectiveness of Danoprevir Against Chronic HCV
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Oseltamivir Use in an Influenza Outbreak: Linking Pharmacology to Pharmacoeconomics
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Estimating Health Outcomes of Antiviral Use in Influenza Outbreaks by Linking PK/PD and Epidemiology via a Transmission Dynamic Model: A Novel Approach
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Understanding the Effect of the HCV Polymerase Inhibitor Mericitabine on Early Viral Kinetics in the Phase 2 JUMP-C and PROPEL Studies
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Comparative Benefit of Malaria Chemoprophylaxis Modeled in United Kingdom Travelers
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Exposure–Response Relationship of Cenicriviroc with Week 24 Virologic Outcomes in Treatment-naïve HIV-1-infected Adults with CCR5-tropic Virus
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Effect of Meal and Antisecretory Agents on the Pharmacokinetics of Danoprevir/Ritonavir in Healthy Volunteers
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Influence of Chronic Hepatitis C Infection on Cytochrome P450 3A4 Activity Using Midazolam as an In Vivo Probe Substrate
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Pharmacokinetics of a Three-way Drug Interaction Between Danoprevir, Ritonavir, and the Organic Anion Transporting Polypeptide (OATP) Inhibitor Ciclosporin
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Pharmacokinetic-pharmacodynamic Determinants of Oseltamivir Efficacy Using Data from Phase 2 Inoculation Studies
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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
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Impact of Low-dose Ritonavir on Danoprevir Pharmacokinetics: Results of Computer-based Simulations and a Clinical Drug-drug Interaction Study
Danoprevir, a potent, selective inhibitor of the hepatitis C virus (HCV) NS3/4A protease, is metabolized by cytochrome P450 (CYP) 3A. Clinical studies in HCV patients have shown a potential need for a high danoprevir daily dose and/or dosing frequency. Ritonavir, an HIV-1 protease inhibitor (PI) and potent CYP3A inhibitor, is used as a pharmacokinetic enhancer […]
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