pre-update Archives

刊物

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…

Certara2014 年 3 月 1 日

Publication

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

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

Certara2014 年 2 月 21 日

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…

Certara2014 年 2 月 13 日

Publication

Clinical Population Pharmacokinetics and Toxicodynamics of Linezolid

Certara2014 年 2 月 10 日

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…

Certara2014 年 2 月 5 日

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…

Certara2014 年 1 月 15 日

Knowledge Base

Simplifying Deconvolution

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

Certara2014 年 1 月 13 日

刊物

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…

Certara2014 年 1 月 1 日

Publication

Incorporating Target Shedding into a Minimal PBPK-TMDD Model for Monoclonal Antibodies

Shedding of a pharmacological target from cells, giving rise to a soluble target that can also bind therapeutic proteins, is…

Certara2014 年 1 月 1 日

Knowledge Base

Cassette Dosing: Advantages and Challenges

Cassette dosing is a technique primarily used in drug discovery efforts in non-clinical studies to…

Certara2013 年 12 月 16 日

pre-update

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?

Incorporating Target Shedding into a Minimal PBPK-TMDD Model for Monoclonal Antibodies

Cassette Dosing: Advantages and Challenges

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