First-tier testing

Artist impression of a cell membrane

Important first indications

Typically, first-tier tests on digestion, absorption, on-target availability or activity, as well as pilot studies on biomarkers or health effects are far less costly and take less time than second-tier tests that may follow. Still, first-tier tests can be predictive to some extent. Their outcome generates useful information that helps making decisions on timing, on investments, on further testing and dossier preparation and on overall communication and business development strategy.




Services provided for first-tier testing may include, for instance, one or more of the following:

  • selection of testing laboratories (based on considerable experience at lsbi with studies in vitro, in animals and in human volunteers)
  • monitoring of contract studies (for instance: investigating digestion, fermentation or availability for absorption using an in vitro model, membrane transport or other cell, tissue or organ culture tests, studies in animal models, kinetic, mechanistic or proof-of-concept studies in human volunteers, or in target animals)
  • consulting with authorities
  • consulting with external experts to address specific issues
  • adapting test strategy if necessary and defining second tier tests, based on proven examples where possible, and based on opinions and guidance from authorities where available (for instance: from EFSA’s NDA Panel)
  • estimating the costs and timing of testing and further scientific/regulatory development
  • estimating overall feasibility and chance of success
  • providing a basis for further decisions