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Pharmacokinetics, Pharmacodynamics, Physiologically-based Pharmacokinetic Modeling of Monoclonal Antibodies Blog Post

Development of monoclonal antibodies (mAbs) and their functional derivatives represents a growing segment of the development pipeline in the pharmaceutical industry. More than 25 mAbs and derivatives have been approved…

Pharmacometric Approaches to Guide Dose Selection of the Novel GPR40 Agonist TAK-875 in Subjects with Type 2 Diabetes Mellitus Blog Post

The G-protein-coupled receptor 40 agonist (GPR40) TAK-875 is being developed as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Pharmacometric approaches…

Autoinhibition of CYP3A4 Leads to Important Role of CYP2C8 in Imatinib Metabolism: Variability in CYP2C8 Activity May Alter Plasma Concentrations and Response Blog Post

Recent data suggest that the role of CYP3A4 in imatinib metabolism is smaller than presumed. This study aimed to evaluate the quantitative importance of different cytochrome P450 (P450) enzymes in…

Optimal Sampling Times for a Drug and Its Metabolite Using Simcyp Simulations as Prior Information Blog Post

Since 2007, it is mandatory for the pharmaceutical companies to submit a Pediatric Investigation Plan to the Pediatric Committee at the European Medicines Agency for any drug in development in…

Simulations to Assess Phase 2 Non-inferiority Trials of Different Doses of Capecitabine in Combination with Docetaxel for Metastatic Breast Cancer Blog Post

A phase II trial in metastatic breast cancer (MBC) (NO16853) failed to show noninferiority (progression-free survival, PFS) of capecitabine 825 mg/m2 plus docetaxel 75 mg/m2 to the registered capecitabine dose…

Calculating Urine PK Parameters Blog Post

Pharmacokinetic analysis normally focuses on systemic exposure to a drug; however, much can be learned from urinary pharmacokinetic parameters. Urinary PK parameters tell you about how much drug was absorbed (at...

Application of PBPK Modeling to Predict Monoclonal Antibody Disposition in Plasma and Tissues in Mouse Models of Human Colorectal Cancer Blog Post

This investigation evaluated the utility of a physiologically based pharmacokinetic (PBPK) model, which incorporates model parameters representing key determinants of monoclonal antibody (mAb) target-mediated disposition, to predict, a priori, mAb disposition in plasma and in tissues, including tumors that express…

What Can We Learn from a Human Mass Balance Study? Blog Post

Mass balance studies are also called “C-14 studies” or “Absorption, Metabolism, and Excretion (AME) studies”. It is important to understand what you are trying to learn from the experiment. The…

Bioavailability Blog Post

Discover bioavailability in pharmacokinetics, its types, the first-pass effect, and calculations. Explore tools for accurate PK/PD modeling with Phoenix.

Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer Blog Post

Simulations were performed for carboplatin/paclitaxel (C/P) plus motesanib or bevacizumab vs. C/P as first-line treatment for advanced non small-cell lung cancer (NSCLC) using a published drug disease model. With 700…

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