pre-update Archives

Publication

Electrocardiographic Data Quality in Thorough QT/QTc Studies

Most drugs with systemic bioavailability have to undergo a thorough QT (TQT) study, which includes…

CertaraMarch 1, 2014

Publication

In Vitro-In Vivo Extrapolation of Drug-induced Proarrhythmia Predictions at the Population Level

Drug cardiotoxicity is a serious issue for patients, regulators, pharmaceutical companies and health service payers…

CertaraMarch 1, 2014

Publication

Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetics Studies: Which Measure of Variability Should be Used?

A new approach for calculation of sample size in pediatric clinical pharmacokinetic studies was suggested based on desired precision for a pharmacokinetic parameter…

CertaraMarch 1, 2014

Publication

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors…

CertaraFebruary 21, 2014

Publication

A Model-based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-malignant Pain

Pain is a major symptom in many medical conditions which can be relieved thanks to…

CertaraFebruary 13, 2014

Publication

Clinical Population Pharmacokinetics and Toxicodynamics of Linezolid

CertaraFebruary 10, 2014

Blog

Hyperlinking: Making the Most of Navigation in eCTD Submissions

When authors generate documents intended for electronic submission they use blue-colored font to indicate where…

CertaraFebruary 5, 2014

Publication

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

The level of the endocannabinoid anandamide is controlled by fatty acid amide hydrolase (FAAH). In…

CertaraJanuary 15, 2014

Knowledge Base

Simplifying Deconvolution

Deconvolution is used to evaluate the absorption kinetics of a drug. Unfortunately the term can…

CertaraJanuary 13, 2014

Publication

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac…

CertaraJanuary 1, 2014

pre-update

Electrocardiographic Data Quality in Thorough QT/QTc Studies

In Vitro-In Vivo Extrapolation of Drug-induced Proarrhythmia Predictions at the Population Level

Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetics Studies: Which Measure of Variability Should be Used?

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

A Model-based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-malignant Pain

Clinical Population Pharmacokinetics and Toxicodynamics of Linezolid

Hyperlinking: Making the Most of Navigation in eCTD Submissions

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

Simplifying Deconvolution

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

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