2016

White Paper

Transform Your Early Drug Development with Population Pharmacokinetic Analysis

Population pharmacokinetic analysis has become a key tool for Clinical Pharmacology experts when working with…

CertaraApril 19, 2016

Publication

Recent Advances in Development and Application of Physiologically-based Pharmacokinetic (PBPK) Models: A Transition from Academic Curiosity to Regulatory Acceptance

There is a renewed surge of interest in applications of physiologically-based pharmacokinetic (PBPK) models by the…

CertaraApril 14, 2016

Publication

Pharmacokinetics and Pharmacodynamics of Gamithromycin in Pulmonary Epithelial Lining Fluid in Naturally Occurring Bovine Respiratory Disease in Multisource Commingled Feedlot Cattle

The objectives of this study were to determine (i) whether an association exists between individual…

CertaraApril 1, 2016

Publication

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

Publication

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

Publication

A Critical Evaluation of the Experimental Design of Studies of Mechanism-based Enzyme Inhibition, with Implications for In Vitro-In Vivo Extrapolation

The published literature on mechanism based inhibition (MBI) of CYPs was evaluated with respect to…

CertaraApril 1, 2016

Publication

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

Blog

Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications

Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3…

CertaraMarch 14, 2016

Publication

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

Publication

Drug-drug Interactions and QT Prolongation as a Commonly Assessed Cardiac Effect—Comprehensive Overview of Clinical Trials

CertaraMarch 1, 2016

Transform Your Early Drug Development with Population Pharmacokinetic Analysis

Recent Advances in Development and Application of Physiologically-based Pharmacokinetic (PBPK) Models: A Transition from Academic Curiosity to Regulatory Acceptance

Pharmacokinetics and Pharmacodynamics of Gamithromycin in Pulmonary Epithelial Lining Fluid in Naturally Occurring Bovine Respiratory Disease in Multisource Commingled Feedlot Cattle

Breast Cancer Resistance Protein Abundance, but Not mRNA Expression, Correlates with Estron e-3-Sulfate Transport in Caco-2

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

A Critical Evaluation of the Experimental Design of Studies of Mechanism-based Enzyme Inhibition, with Implications for In Vitro-In Vivo Extrapolation

Population Pharmacokinetics and Exposure-response of Trametinib, a MEK Inhibitor, in Patients with BRAF V600 Mutation-positive Melanoma

Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications

Pharmacokinetics of a Single Dose of Oral and Subcutaneous Meloxicam in Caribbean Flamingos (Phoenicopterus ruber ruber)

Drug-drug Interactions and QT Prolongation as a Commonly Assessed Cardiac Effect—Comprehensive Overview of Clinical Trials

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