Pre-formulation studies

In vitro bioequivalence

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mercoledì 13 aprile 2016

For approval of generic drug products, bioequivalence testing   is considered as a surrogate for clinical evaluation of the therapeutic   equivalence of drug products based on the fundamental bioequivalence assumption that when two drug products are equivalent in bioavailability, they will reach the same therapeutic effect. By performing in vitro studies we can have a control over the system. It also allows to mimic the biological conditions. In vitro studies reduce the cost and number of trials.

How can we help you?

  • Test generic drug products for which there is an approved Reference Listed Drug (RLD)
  • Test new drug products for which adequate clinical studies have already been conducted
  • Test reformulated drug products

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