Preformulation Studies

In Vitro Bioequivalence

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mercoledì 13 aprile 2016

A statistical test is proposed for in vitro bioequivalence testing between drug products. We developed dedicated programs to meet all requirements necessary for in vitro bioequivalence and stability.

  • 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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