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Preclinical & clinical studies

Research and Development in pharmaceutical companies is a critical issue in terms of investment and patent protection. Every year, pharmaceutical and biotech companies screen 10,000 drugs. Only 250 drugs reach pre-clinical phase.

The goals of pre-clinical studies are to assess the pharmacodynamics (PD), pharmacokinetics (PK), ADME and toxicity of drugs in animals.

Non-clinical assesments are to be considered as a crucial step in terms of risk assesment prior first-in-man clinical trials. Indeed, due to rapid technology breakthroughs, preclinical studies can detect, in vitro and in vivo the compounds that have the less possible adverse effects to go to phase I studies. These data collected allows researchers to allometrically estimate a safe starting dose of drug for clinical trials.

Bertin Pharma offers services and expertises in the fields of preclinical & clinical studies including:

in accordance with GLP (Good Laboratory Practice) in ICH guidelines.

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