PK/TK Analysis

Pharmacokinetic/Toxicokinetic Non-compartmental Analysis Services Navigating pre-clinical regulatory safety assessments for drug candidate selection and characterizing pharmacokinetics (PK) within single studies to make dose escalation decisions are crucial steps in the drug discovery and development process. Non-compartmental analysis (NCA)—an approach often used to estimate PK and toxicokinetic (TK) parameters, such as clearance, elimination half-life, Tmax, Cmax, […]

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

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 […]

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Potential Sources of Inter-subject Variability in Monoclonal Antibody Pharmacokinetics

Understanding inter-subject variability in drug pharmacokinetics and pharmacodynamics is important to ensure that all patients attain suitable drug exposure to achieve efficacy and avoid toxicity. Inter-subject variability in the pharmacokinetics of therapeutic monoclonal antibodies (mAbs) is generally moderate to high; however, the factors responsible for the high inter-subject variability have not been comprehensively reviewed. In […]

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Grant and Partnership Scheme

Grant and Partnership Scheme Overview: Certara is committed to supporting research at associate Academic Centers of Excellence and not-for-profit institutions. We have been proud to contribute to research on an ad-hoc basis in partnership with our academic associates. Following the success of these collaborations, and an increase in interest in matters relating to in vitro-in vivo […]

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Calculating the Elimination Rate Constant

Nathan Teuscher

The elimination rate constant is the rate at which drug is cleared from the body assuming first-order elimination. Various abbreviations are used to represent the elimination rate constant including ke, kel, λ, and λz. The calculation of the elimination rate constant can be done using pharmacokinetic parameters or it can be done directly from a […]

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Topics: PK/PD Modeling & Simulation

Bioanalysis from a PK Perspective

Nathan Teuscher

The field of bioanalytical chemistry, or bioanalysis, is an important area of research that has a direct impact on the work of pharmacokineticists. Essentially, bioanalysis converts a blood sample (or any other matrix) into a drug concentration by the use of analytical equipment. Over the next few weeks, I would like to cover a variety […]

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Topics: PK/PD Modeling & Simulation

What Can We Learn from Dose Normalization?

Nathan Teuscher

Dose normalization is a common calculation performed with pharmacokinetic parameters. The general process is to divide the PK parameters by the administered dose. This is performed for each individual or treatment group in a study, and then comparisons of dose-normalized parameters can be performed. But, why would we want to dose normalize PK parameters? What […]

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Topics: PK/PD Modeling & Simulation

Extrapolating AUC to Infinity

Nathan Teuscher

Area under the curve or AUC is a pharmacokinetic statistic used to describe the total exposure to a drug. More specifically, it is the time-averaged concentration of drug circulating in the body fluid analyzed (normally plasma, blood or serum). Standard calculation of AUC involves using non-compartmental techniques to calculate the AUC from time 0 to […]

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Topics: PK/PD Modeling & Simulation

Simplifying Deconvolution

Nathan Teuscher

Deconvolution is used to evaluate the absorption kinetics of a drug. Unfortunately the term can be confusing and explanations are generally even more confusing. While deconvolution is not a simple topic, I believe it can be understood so that more scientists can apply the principles to their work. Before I define deconvolution, let me define […]

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Topics: PK/PD Modeling & Simulation