GENOTOXICITY

TRL offers drug metabolism and pharmacokinetic (DMPK) studies in support of drug candidate selection or regulatory submission.  Based on specified goals, our skilled in-vitro and in-vivo ADME scientists, together with our pharmacokineticists have the ability to design and interpret both in-vitro and in-vivo components of your drug metabolism studies.

The PK parameters assessed include AUC, half-life, volume of distribution, bioavailability, AUC, Cmax, Tmax, first order rate constant of absorption, terminal elimination rate constant; clearance, volume of distribution, and bioavailability. We have experience with a number of routes of administration, including intravenous (IV), oral (PO), transdermal, intra-peritoneal (IP), intra-muscular (IM), subcutaneous (SC), as well as other more specialized techniques, depending on the specific design and objective of the study.

The following study types are performed at TRL:

• Custom-designed ADME studies in multiple species of laboratory animals
• Drug kinetics in plasma
• Quantitative tissue distribution of drug
• Metabolic profiling of drug using animal and human microsomes, S9 and hepatocytes