Nonlinear PK: What Does That Mean?
You may come across a phrase like the following and wonder what it means: “……
CertaraFebruary 17, 2013
Why Cmax is a Continuous Variable and Tmax is a Categorical Variable
The maximum observed concentration (Cmax) and the time of Cmax (tmax) are both obtained directly…
CertaraFebruary 11, 2013
What is Quantification Anyway?
Bioanalytical analysis is a fundamental tool for the pharmacokineticist. The results of a bioanalysis are…
CertaraFebruary 5, 2013
Inhibitory Effect of Ketoconazole on the Pharmacokinetics of a Multireceptor Tyrosine Kinase Inhibitor BMS-690514 in Healthy Participants: Assessing the Mechanism of the Interaction with Physiologically-based Pharmacokinetic Simulations
BMS-690514, a selective inhibitor of the ErbB and vascular endothelial growth factor receptors, has shown…
CertaraFebruary 1, 2013
Bioavailability of Intranasal vs. Rectal Diazepam
There remains an unmet medical need in the out-of-hospital management of seizure emergencies because older…
CertaraFebruary 1, 2013
Analysis of Level A In Vitro-In Vivo Correlations for an Extended-release Formulation with Limited Bioavailability
A two-stage, numerical deconvolution approach was employed to develop level A in vitro–in vivo correlations…
CertaraJanuary 21, 2013
Pharmacometric Approaches to Guide Dose Selection of the Novel GPR40 Agonist TAK-875 in Subjects with Type 2 Diabetes Mellitus
The G-protein-coupled receptor 40 agonist (GPR40) TAK-875 is being developed as an adjunct to diet…
CertaraJanuary 9, 2013
Absolute Abundance and Function of Intestinal Drug Transporters: A Prerequisite for Fully Mechanistic In Vitro-In Vivo Extrapolation of Oral Drug Absorption
The use of whole body physiological-based pharmacokinetic (PBPK) models linked with in vitro-in vivo extrapolation…
CertaraJanuary 1, 2013
Simulations to Assess Phase 2 Non-inferiority Trials of Different Doses of Capecitabine in Combination with Docetaxel for Metastatic Breast Cancer
A phase II trial in metastatic breast cancer (MBC) (NO16853) failed to show noninferiority (progression-free…
CertaraDecember 26, 2012
Calculating Urine PK Parameters
Pharmacokinetic analysis normally focuses on systemic exposure to a drug; however, much can be learned…
CertaraDecember 6, 2012
