Pre-Clinical studies

Anistème offers a range of services for the management of studies designed to demonstrate drug safety and efficacy. These studies are performed at the premises of well known CROs or experimental farms on domestic species (livestock or companion animals). Laboratory analyses are outsourced to well known laboratories.

All these studies are performed in compliance with Good Laboratory Practice (EU Directive 2004/10) and European legislation for animal well-being (Directive 86/609 and applicable OECD guidelines).

Anistème manages all stages of GLP studies to meet regulatory requirements:

• Writing study plans and calls for tender.
  • Inclusion criteria.
  • Calculation of study sample size (bioequivalence study).
  • Choice of a feeding regimen that matches study goals.
  • Analytical technique requirements (limits of detection and quantification, linearity range, enantioselectivity, cost per analysis).
  • Choice of an experimental model.

• Selecting the best proposal.
• Protocol reviewing and commenting.
• In-life and in vitro phases support.
• Report reviewing and commenting.
• If necessary, requesting additional data or analyses to help the expert comment on study results.
• Performing specific additional statistical or pharmacokinetic analyses (eg PK/PD modeling).