Preclinical Safety Testing: Use of Transgenic Animals

Transgenic and genetically modified animal models are increasingly being used in the study of disease and for the safety assessment of new compounds.  Use of these models enhances understanding of the role that specific genes play in biological pathways.   The primary...

Preclinical Offshoring Anticipated to Continue: Survey

In the next 2-5 years, large pharmaceutical companies plan to increase outsourcing of preclinical work, with emphasis on Discovery and non-GLP Toxicology.  This trend is driven by the reductions in internal preclinical capability within Big Pharma.  In an apparent...

Zebrafish: Preclinical Screening and Toxicity Assessment

Zebrafish offer a nonclinical model for the high-throughput screening of drug compounds, including toxicity assessment, with resolution at the cellular level in living vertebrate organisms.  These small, freshwater, tropical fish share genetic and biochemical...

Drug Pharmacokinetic Comparison between Humans and Monkeys

To verify the availability of pharmacokinetic parameters in cynomolgus monkeys, hepatic availability (Fh) and the fraction absorbed (Fa) multiplied by intestinal availability (Fg) were evaluated to determine their contributions to absolute bioavailability (F) after...