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Month: July 2016

Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment

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Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime for the treatment of certain serious Gram-negative infections. As avibactam is primarily excreted unchanged in the urine, renal impairment may affect its pharmacokinetics. This Phase 1 study investigated the effect of renal impairment and hemodialysis on avibactam pharmacokinetics and safety. … Continued

A Tutorial on Pharmacodynamic Scripting Facility in Simcyp

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The Simcyp® Simulator provides a framework for mechanistic Physiologically-Based Pharmacokinetic/Pharmacodynamic modelling of potentially interacting drugs. It also provides a scripting facility, using the Lua language, for developing customised pharmacodynamic and toxicity models driven by drug concentrations at the site of action.

Informing Pediatric Drug Development: A Selection from Certara’s Best of Blogs

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A selection of short essays by Certara’s pediatric drug development experts. Learn about our technologies and strategies for pediatric drug development to inform dose selection, including PK/PD simulations using sparse data analysis and our Simcyp Pediatric Simulator. Certara’s regulatory writing consultancy, Synchrogenix, also offer regulatory strategy for pediatrics.

Certara’s Best of Blogs 2015

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A selection of short essays from our blog, written to empower our customers with biosimulation 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.

Status of QSP Modeling in the Pharmaceutical Industry

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A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to lack of efficacy,1 suggesting inadequate understanding in therapeutic targets’ biology and their relevance to disease progression or modulation. Quantitative systems pharmacology (QSP) has the promise of increasing the probability of success in R&D by bridging scientific gaps between disciplines to enable … Continued

More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances

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Rosuvastatin is a substrate of choice in clinical studies of organic anion-transporting polypeptide (OATP)1B1- and OATP1B3-associated drug interactions; thus, understanding the effect of OATP1B1 polymorphisms on the pharmacokinetics of rosuvastatin is crucial. Here, physiologically-based pharmacokinetic (PBPK) modeling was coupled with a power calculation algorithm to evaluate the influence of sample size on the ability to … Continued

How Does the In Vivo Biliary Elimination of Drugs Change with Age? Evidence from In Vitro and Clinical Data Using a Systems Pharmacology Approach

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Information on the developmental changes in biliary excretion (BE) of drugs is sparse. The aims of this study were to collate literature data on the pharmacokinetics of biliary excretion of drugs used in pediatrics and to apply a physiologically-based pharmacokinetic (PBPK) model to predict their systemic clearance (CL) with a view to elucidating age-related changes … Continued

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