Model-based Meta-analysis: An Innovative Methodology Comes of Age
MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions.…
CertaraJuly 14, 2016
Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment
Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime…
CertaraJuly 12, 2016
A Tutorial on Pharmacodynamic Scripting Facility in Simcyp
The Simcyp® Simulator provides a framework for mechanistic Physiologically-Based Pharmacokinetic/Pharmacodynamic modelling of potentially interacting drugs.…
CertaraJuly 9, 2016
Status of QSP Modeling in the Pharmaceutical Industry
A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to…
CertaraJuly 6, 2016
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…
CertaraJuly 1, 2016
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…
CertaraJuly 1, 2016
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…
CertaraJuly 1, 2016
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…
CertaraJuly 1, 2016
