PHARMACOKINETICS

Our dedicated Pharmacokinetics group works closely with other operational departments to provide pharmacokinetic data for our preclinical studies, FDA Animal Rule studies, and veterinary clinical studies in a timely fashion. Utilizing industry-standard WinNonlin® system that was validated according to GLP requirements, the following types of study designs are provided:

• Non-compartmental pharmacokinetics
• Compartmental pharmacokinetics/simulations
• Ascending dose (assessment of dose proportionality)
• Repeat dose (assessment of multiple dose linearity)
• Bioavailability and bioequivalence
• Drug interaction studies
• Special populations
• Pharmacodynamic and PK/PD modeling
• Deconvolution