Assessment of Bioequivalence

Assessment of the bioequivalence of generic versions of certain reference drugs is complicated by the presence of endogenous levels of said compounds which cannot be distinguished from externally derived compound levels following drug administration. If unaccounted for, the presence of endogenous compound biases towards equivalence in bioequivalence studies of these drugs. Bioequivalence assessments may be complicated further as disposition of the exogenous analogue can be subject to various endogenous processes resulting in nonlinear pharmacokinetics. To overcome these inherent biases a number of different strategies have been employed. 

  • Solubility based on highest dose strength of an IR product
  • Establishment of bioequivalence criteria
  • Drugs possessing narrow therapeutic index
  • Waivers of In Vivo Study Requirements
  • Biopharmaceutics Classification System (BCS)
  • Topical dosage forms
  • Respiratory dosage forms
  • Transdermal dosage forms
  • Evaluation of highly variable drugs and drug products

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