Can QSP Save Lives? Lessons from the Bial Trial Debacle
One of the biggest challenges for the pharmaceutical industry is the high rate of drug…
CertaraMay 4, 2016
Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Growth Kinetics in Medullary Thyroid Cancer Patients Receiving Cabozantinib
Nonlinear mixed effects models were developed to describe the relationship between cabozantinib exposure and target…
CertaraApril 27, 2016
Breast Cancer Resistance Protein Abundance, but Not mRNA Expression, Correlates with Estron e-3-Sulfate Transport in Caco-2
Transporter mRNA and protein expression data are used to extrapolate in vitro transporter kinetics to in…
CertaraApril 1, 2016
Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia
X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting…
CertaraApril 1, 2016
Population Pharmacokinetics and Exposure-response of Trametinib, a MEK Inhibitor, in Patients with BRAF V600 Mutation-positive Melanoma
The purpose of this study was to characterize the pharmacokinetics of oral trametinib, a first in…
CertaraApril 1, 2016
Pharmacokinetics of a Single Dose of Oral and Subcutaneous Meloxicam in Caribbean Flamingos (Phoenicopterus ruber ruber)
To determine the pharmacokinetics of meloxicam in Caribbean flamingos ( Phoenicopterus ruber ruber), a pilot…
CertaraMarch 1, 2016
Population PK & Dosing Implications for Cobimetinib in Cancer Patients
A population pharmacokinetic model was developed for cobimetinib in cancer patients. Covariates had minimal impact…
CertaraNovember 1, 2015
