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 survival, PFS) of capecitabine 825 mg/m2 plus docetaxel 75 mg/m2 to the registered capecitabine dose of 1,250 mg/m2 plus docetaxel 75 mg/m2 . We developed a modeling framework based on NO16853 and the pivotal phase III MBC study, SO14999, to … Continued

Changing Column Names and Units in Phoenix WinNonlin

One of the most common tasks when working with data in Phoenix WinNonlin is to change the column titles or units. In many software packages that consists of clicking on the data spreadsheet and re-typing the new information; however, with Phoenix, you have to take a few additional steps. Here’s some quick tips on how … Continued

How to Filter Data with Phoenix WinNonlin

Phoenix WinNonlin is Certara’s new implementation of the popular pharmacokinetic software that has been the mainstay of non-compartmental analysis for over 15 years. But, this newest version is the biggest change in the software since the original PC Nonlin was converted to the Windows-based “WinNonlin” (i.e. Windows Nonlin). In Phoenix WinNonlin, there are a powerful … Continued

Calculating Urine PK Parameters

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 a minimum), and how much drug is eliminated through the kidney. Often it provides easy access to metabolites that are also eliminated in the urine. … Continued

Plexxikon Selects Certara’s D360 for Scientific Data Access and Analysis

D360 allows Plexxikon’s researchers to easily query and analyze biological assay and chemical registration data from a single dashboard. ST. LOUIS, MO – December 5, 2012 – Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, announced that Plexxikon selected Certara’s D360™ software solution for scientific data … Continued

Novel Biocompatible Disease Modifying Nanomedicine of VIP for Rheumatoid Arthritis

Despite advances in rheumatoid arthritis (RA) treatment, efficacious and safe disease-modifying therapy still represents an unmet medical need. Here, we describe an innovative strategy to treat RA by targeting low doses of vasoactive intestinal peptide (VIP) self-associated with sterically stabilized micelles (SSMs). This spontaneous interaction of VIP with SSM protects the peptide from degradation or … Continued

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

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 target antigens. Monte Carlo simulation techniques were employed to predict the disposition of two mAbs, 8C2 (as a non-binding control mouse IgG1 mAb) and T84.66 (a high-affinity murine IgG1 anti-carcinoembryonic antigen … Continued