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
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
Simplifying Deconvolution
Deconvolution is used to evaluate the absorption kinetics of a drug. Unfortunately the term can…
CertaraJanuary 13, 2014
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
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…
CertaraJanuary 1, 2014
Cassette Dosing: Advantages and Challenges
Cassette dosing is a technique primarily used in drug discovery efforts in non-clinical studies to…
CertaraDecember 16, 2013
Anatomical, Physiological and Metabolic Changes with Gestational Age During Normal Pregnancy: A Database for Parameters Required in Physiologically-based Pharmacokinetic Modeling
Pregnancy is associated with considerable changes in the physiological, anatomical and biochemical attributes in women.…
CertaraDecember 13, 2013
Bottom-up Modeling and Simulation of Tacrolimus Clearance: Prospective Investigation of Blood Cell Distribution, Sex and CYP3A5 Expression as Covariates and Assessment of Study Power
The objectives were to investigate the ability of population-based in vitro-in vivo extrapolation (IVIVE) to…
CertaraDecember 1, 2013
An Evaluation of the Pharmacokinetics of Treprostinil Diethanolamine in Subjects with Hepatic Impairment
Treprostinil diolamine (oral treprostinil) is a prostacyclin analogue under evaluation for the treatment for pulmonary…
CertaraDecember 1, 2013
