Vortex © 2012 Privacy Policy

Combining Private Enterprise

with Academic Excellence

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® software that was validated in-house.  We offer preclinical pharmacokinetics in multiple species:

 

         •    Mice

         •    Rats (cannulated for serial sampling or sparse sampling)

         •    Rabbits

         •    Dogs

         •    Minipigs

         •    Non-Human Primates

 

Input into study design, including preclinical-to-clinical considerations (allometric scaling) utilizing information from preclinical toxicokinetic studies

 

         •    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

 

Our pharmacokinetic consultancy service provides advice and support for all aspects of clinical pharmacokinetics and is offered as part of a complete development program, as a full-service single-study package, or as a stand-alone service. Upon request, pharmacokinetic parameter estimation output and reports may include a comprehensive text interpretation of the data.

Pharmacokinetics