Nonlinear PK: What Does That Mean?
You may come across a phrase like the following and wonder what it means: “……
Certara2013 年 2 月 17 日
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…
Certara2013 年 2 月 11 日
What is Quantification Anyway?
Bioanalytical analysis is a fundamental tool for the pharmacokineticist. The results of a bioanalysis are…
Certara2013 年 2 月 5 日
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…
Certara2013 年 2 月 1 日
Bioavailability of Intranasal vs. Rectal Diazepam
There remains an unmet medical need in the out-of-hospital management of seizure emergencies because older…
Certara2013 年 2 月 1 日
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…
Certara2013 年 1 月 21 日
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…
Certara2013 年 1 月 9 日
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…
Certara2013 年 1 月 1 日
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…
Certara2012 年 12 月 26 日
Calculating Urine PK Parameters
Pharmacokinetic analysis normally focuses on systemic exposure to a drug; however, much can be learned…
Certara2012 年 12 月 6 日
