Arsenal Capital Partners Acquires Leading Model-based Drug Development Company Certara

NEW YORK, NY- Dec. 19, 2013 – Arsenal Capital Partners, a leading New York-based private equity firm that invests in middle market healthcare and specialty industrial companies, announced today the acquisition of Certara, the leading provider of model-based drug development and data analytics software and consulting services to the biopharmaceutical research and development market. Certara … Continued

Cassette Dosing: Advantages and Challenges

Cassette dosing is a technique primarily used in drug discovery efforts in non-clinical studies to collect pharmacokinetic data from multiple drug candidates in a single experiment. A typical cassette dosing pharmacokinetic study involves simultaneous administration of 5-10 compounds to a set of animals. Serial blood samples are obtained and LC/MS/MS techniques are used to measure … Continued

Anatomical, Physiological and Metabolic Changes with Gestational Age During Normal Pregnancy: A Database for Parameters Required in Physiologically-based Pharmacokinetic Modeling

Pregnancy is associated with considerable changes in the physiological, anatomical and biochemical attributes in women. These may alter the exposure to xenobiotics between pregnant and non-pregnant women who receive similar doses, with implications for different susceptibility to environmental pollutants or therapeutic agents. Physiologically based pharmacokinetic (PBPK) models together with in vitro in vivo extrapolation (IVIVE) … Continued

Certara Has Partnered With LabLogic Systems to Facilitate Faster Drug Discovery Analyses

Certara’s Phoenix WinNonlin Can Now be Integrated With LabLogic’s Debra Software – customers can now port ADME and protein-binding data directly from Debra to Phoenix ST. LOUIS, MO – Dec. 10, 2013 – Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, today … Continued

What is GLP (Good Laboratory Practice)?

Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must … Continued

Bottom-up Modeling and Simulation of Tacrolimus Clearance: Prospective Investigation of Blood Cell Distribution, Sex and CYP3A5 Expression as Covariates and Assessment of Study Power

The objectives were to investigate the ability of population-based in vitro-in vivo extrapolation (IVIVE) to reproduce the influence of haematocrit on the clearance of tacrolimus, observed previously, and to assess the power of clinical studies to detect the effects of covariates on the clearance of tacrolimus. A population-based pharmacokinetic simulator (Simcyp®) was used to simulate … Continued

An Evaluation of the Pharmacokinetics of Treprostinil Diethanolamine in Subjects with Hepatic Impairment

Treprostinil diolamine (oral treprostinil) is a prostacyclin analogue under evaluation for the treatment for pulmonary arterial hypertension (PAH). This study assessed the pharmacokinetics (PK) and safety of treprostinil following oral administration of a single sustained-release 1 mg dose in subjects with hepatic impairment. Four cohorts, including healthy volunteers, and subjects with mild, moderate and severe hepatic … Continued

Modeling of Pharmacokinetic Systems Using Stochastic Deconvolution

In environments where complete mechanistic knowledge of the system dynamics is not available, a synergy of first-principle concepts, stochastic methods and statistical approaches can provide an efficient, accurate, and insightful strategy for model development. In this work, a system of ordinary differential equations describing system pharmacokinetics (PK) was coupled to a Wiener process for tracking the … Continued

Differences in Cytochrome P450-mediated Pharmacokinetics Between Chinese and Caucasian Populations Predicted by Mechanistic Physiologically-based Pharmacokinetic Modeling

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines emphasize the need for better understanding of the influence of ethnicity on drug response to minimize duplication of clinical studies, thereby expediting drug approval. We have developed a Chinese database for the prediction of differences in the population kinetics of drugs mainly metabolized … Continued