CBSETs experience, technical and scientific expertise enable development and application of in-vitro and in-vivo kinetic models for combination products. Drug elution and polymer resorption characteristics, and disposition and elimination kinetics play a key role in the safety and efficacy of combination products. CBSET employs state of the art facilities to evaluate Absorption, Disposition, Metabolism, and Excretion (ADME) and has significant resources and expertise in the kinetic evaluation of combination products.
Pharmaceutical and Biotechnology Discovery Services: Currently offered
CBSET offers high throughput non-GLP in-vivo discovery screening services in small animals including: in-vivo ADMET, rapid pharmacokinetic screening, and pharmacology. CBSET offers quick study starts, accurate dosing, and rapid reporting.
Pharmacokinetic Data analysis: Currently offered
Pharmacokinetic data analysis for animal and human radiolabelled studies, human clinical trials and comprehensive interpretation of data:
- Study Design
- Model independent non-compartmental pharmacokinetics
- Compartmental pharmacokinetics /simulations - WinNonlin®
- Dose proportionality
- Repeat dose & multiple dose linearity
- Bioavailability and bioequivalence
- Drug interaction studies
- Pharmacodynamic and PK/PD modeling
Radiolabeled studies: (Q2/2007)
CBSET has full licensure for radioisotopes including: (3H, 14C, 125I, 131I, 99Tc). Study designs to be offered include:
- Mass Balance
- Tissue distribution
- Pharmacokinetics of radiolabeled compounds
