FDA in Bio-equivalence

The Unites States Food and Drug administration (FDA) has defined bioequivalence as. “the absence of a major distinction within the ratee and extent to that the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes obtainable at the site of drug action when administered at the same molar dose under the similar conditions in an appropriately designed study.

  • Track 1-1 IND (Investigational New Drug)
  • Track 2-2 NDA (New Drug Application)

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