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Model-based Meta-analysis for Quantifying Paclitaxel Dose Response in Cancer Patients Blog Post

Model-based meta-analysis of dose response is a sophisticated method to guide dose and regimen selection. In this report, the effects of paclitaxel dose and regimen (weekly or every 3 weeks)…

What Can We Learn from Dose Normalization? Blog Post

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...

Exploratory Modeling and Simulation to Support Development of Motesanib in Asian Patients with Non-small Cell Lung Cancer Based on MONET1 Study Results Blog Post

The motesanib phase III MONET1 study failed to show improvement in overall survival (OS) in non–small cell lung cancer, but a subpopulation of Asian patients had a favorable outcome. We…

Physiologically-based Pharmacokinetic Modeling Framework for Quantitative Prediction of an Herb–Drug Interaction Blog Post

Herb–drug interaction predictions remain challenging. Physiologically based pharmacokinetic (PBPK) modeling was used to improve prediction accuracy of potential herb–drug interactions using the semipurified milk thistle preparation, silibinin, as an exemplar…

Population Pharmacokinetics of Azithromycin in Whole Blood, Peripheral Blood Mononuclear Cells, and Polymorphonuclear Cells in Healthy Adults Blog Post

Azithromycin’s extensive distribution to proinflammatory cells, including peripheral blood mononuclear cells (PBMCs) and polymorphonuclear cells (PMNs), may be important to its antimicrobial and anti-inflammatory properties. The need to simultaneously predict…

Impact of Electrocardiographic Data Quality on Moxifloxacin Response in Thorough QT/QTc Studies Blog Post

Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive control, typically moxifloxacin, with a well-described QTc effect. This study tested two hypotheses: that (i)…

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers Blog Post

Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 approved for second line treatment of advanced renal cell carcinoma. The…

Hyperlinking: Making the Most of Navigation in eCTD Submissions Blog Post

When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information….

A Systems Pharmacology Perspective on the Clinical Development of Fatty Acid Amide Hydrolase Inhibitors for Pain Blog Post

The level of the endocannabinoid anandamide is controlled by fatty acid amide hydrolase (FAAH). In 2011, PF-04457845, an irreversible inhibitor of FAAH, was progressed to phase II clinical trials for…

Simplifying Deconvolution Blog Post

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…