semlerresearch

Semler Research Center, in strategic collaboration with state-of-the-art, GLP compliant pre-clinical facilities, can design and implement comprehensive studies for NCEs and biologicals from lead to phase clinical studies.

Our formulation capabilities include:

• Proof-of-concept and prototype formulations for early stage animal studies as drug discovery support
• Bio-analytical support for animal pharmacokinetics and bioavailability studies
• Screening of potential formulations prior to pilot bioequivalence studies in human volunteers using CACO-2 cell permeability studies or animal studies

In addition, we conduct toxicology studies including in vitro genetic testing (Ames, Chromosome Aberration, Micronucleus) and in vivo studies that include acute to chronic toxicity, carcinogenicity, development and reproduction studies, safety pharmacology (core battery), micro-dosing (phase 0), immuno-toxicology (core battery) and environmental risk assessment.

We also offer customized studies to profile drug candidates or metabolites in vitro and in vivo. Our animal models include rodents and non-rodents (rat, mouse, rabbit, guinea pigs& dog) using all common routes of administration.