Publication

Pharmacometric Approaches to Guide Dose Selection of the Novel GPR40 Agonist TAK-875 in Subjects with Type 2 Diabetes Mellitus

The G-protein-coupled receptor 40 agonist (GPR40) TAK-875 is being developed as an adjunct to diet…

Certara2013 年 1 月 9 日

Publication

Absolute Abundance and Function of Intestinal Drug Transporters: A Prerequisite for Fully Mechanistic In Vitro-In Vivo Extrapolation of Oral Drug Absorption

The use of whole body physiological-based pharmacokinetic (PBPK) models linked with in vitro-in vivo extrapolation…

Certara2013 年 1 月 1 日

Publication

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…

Certara2012 年 12 月 26 日

Blog Knowledge Base

Calculating Urine PK Parameters

Pharmacokinetic analysis normally focuses on systemic exposure to a drug; however, much can be learned…

Certara2012 年 12 月 6 日

Publication

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…

Certara2012 年 12 月 4 日

知识库

What Can We Learn from a Human Mass Balance Study?

Mass balance studies are also called “C-14 studies” or “Absorption, Metabolism, and Excretion (AME) studies”.…

Certara2012 年 11 月 27 日

Blog Knowledge Base

生物利用度

Discover bioavailability in pharmacokinetics, its types, the first-pass effect, and calculations. Explore tools for accurate…

Certara2012 年 11 月 4 日

Publication

Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer

Simulations were performed for carboplatin/paclitaxel (C/P) plus motesanib or bevacizumab vs. C/P as first-line treatment…

Certara2012 年 11 月 1 日

Publication

Characterization of Exposure Versus Response of Edoxaban in Patients Undergoing Total Hip Replacement Surgery

Edoxaban is an oral direct factor Xa inhibitor approved for the prevention of venous thromboembolism…

Certara2012 年 11 月 1 日

Knowledge Base

Designing a Clinical Drug-drug Interaction Study

After a much longer delay that I expected, I am back to blogging on a…

Certara2012 年 10 月 29 日

Modeling and Simulation – PK/PD

Pharmacometric Approaches to Guide Dose Selection of the Novel GPR40 Agonist TAK-875 in Subjects with Type 2 Diabetes Mellitus

Absolute Abundance and Function of Intestinal Drug Transporters: A Prerequisite for Fully Mechanistic In Vitro-In Vivo Extrapolation of Oral Drug Absorption

Simulations to Assess Phase 2 Non-inferiority Trials of Different Doses of Capecitabine in Combination with Docetaxel for Metastatic Breast Cancer

Calculating Urine PK Parameters

Novel Biocompatible Disease Modifying Nanomedicine of VIP for Rheumatoid Arthritis

What Can We Learn from a Human Mass Balance Study?

生物利用度

Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer

Characterization of Exposure Versus Response of Edoxaban in Patients Undergoing Total Hip Replacement Surgery

Designing a Clinical Drug-drug Interaction Study

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