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Model Informed Drug Development

Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome Publication

Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome

Teduglutide, a synthetic glucagon-like peptide-2 (GLP-2) analog with activity relating to the regeneration, maintenance, and…
Certara
December 1, 2009
Pre-clinical Assessment of the Absorption, Distribution, Metabolism, and Excretion of GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide), an Orally Bioavailable Systemic Hedgehog Signaling Pathway Inhibitor Publication

Pre-clinical Assessment of the Absorption, Distribution, Metabolism, and Excretion of GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide), an Orally Bioavailable Systemic Hedgehog Signaling Pathway Inhibitor

GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide) is a potent, selective Hedgehog (Hh) signalling pathway inhibitor being developed for the…
Certara
November 1, 2009
The Conduct of In Vitro Studies to Address Time-dependent Inhibition of Drug-metabolizing Enzymes: A Perspective of the Pharmaceutical Research and Manufacturers of America (PhRMA) Publication

The Conduct of In Vitro Studies to Address Time-dependent Inhibition of Drug-metabolizing Enzymes: A Perspective of the Pharmaceutical Research and Manufacturers of America (PhRMA)

Time-dependent inhibition (TDI) of cytochrome P450 (P450) enzymes caused by new molecular entities (NMEs) is…
Certara
July 1, 2009