Status of QSP Modeling in the Pharmaceutical Industry
A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to…
Certara2016 年 7 月 6 日
More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances
Rosuvastatin is a substrate of choice in clinical studies of organic anion-transporting polypeptide (OATP)1B1- and…
Certara2016 年 7 月 1 日
How Does the In Vivo Biliary Elimination of Drugs Change with Age? Evidence from In Vitro and Clinical Data Using a Systems Pharmacology Approach
Information on the developmental changes in biliary excretion (BE) of drugs is sparse. The aims…
Certara2016 年 7 月 1 日
Short-term Efficacy Reliably Predicts Long-term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-based Meta-analysis
The objective of this study was to assess the relationship between short-term and long-term treatment…
Certara2016 年 7 月 1 日
Potential Sources of Inter-subject Variability in Monoclonal Antibody Pharmacokinetics
Understanding inter-subject variability in drug pharmacokinetics and pharmacodynamics is important to ensure that all patients…
Certara2016 年 7 月 1 日
Considering Age Variation When Coining Drugs as High Versus Low Hepatic Extraction Ratio
The hepatic extraction ratio (EH) is commonly considered an "inherent attribute" of drug. It determines…
Certara2016 年 7 月 1 日
Pharmacokinetic Profile of Defibrotide in Patients with Renal Impairment
Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is an unpredictable, potentially life-threatening complication…
Certara2016 年 6 月 11 日
