In addition to providing clients with traditional
PK data analysis, interpretation, and report preparation, Calvert scientists are
available for consultation in the experimental design of pharmacokinetic and
pharmacodynamic studies. We have developed cost-effective protocols to
determine initial PK profiles for lead candidates using virtually all routes of
administration in mouse, rat, rabbit, dogs, mini-pig and non-human primates.
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We offer comprehensive services in preclinical
pharmacokinetics from protocol design, formulation development, in-life, sample
and data analysis to report preparation. Calvert also provides
assistance in working with regulatory requirements to expedite product
development. In sharing a common goal, Calvert acts according
to clients’ needs by using innovative approaches for an unequivocal result to
a specific study objective, and making effective and efficient utilization of
resources and laboratory animals.
Summary of Pharmacokinetics Services:
- Preclinical pharmacokinetics from study design to
report
- Pharmacokinetics and toxicokinetics
- Multi-component PK screening
- Formulation evaluations/Bioavailability
- Simulation to assist pharmacology/toxicology studies
- Interspecies scaling and prediction of human exposure
- Non-Naive non-human primate colony
- Parallel or Crossover study designs
- Non-Naive dog colony
- Radioactive Mass balance studies
- Radioactive Tissue distribution studies
- Facility licensed for radioisotopes
3H, 14C, 123I, 125I, 131I,
99mTc, 35S, 45Ca, 47Ca, 51Cr,
51Fe, 111In, 67Ga, 67Cu, 32P
- Plasma Protein binding and blood cell partitioning
studies
- On-site analytical services:
UV-HPLC, fluorescence-HPLC, UV-VIS spectrophotometry,
ELISA
- On-site dosing formulation
analysis
- LC/MS/MS services availabel
through our preferred partner Frontage Laboratories, Inc., Malvern, PA
(www.frontagelab.com)
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