Bioequivalence Studies and Assessment

Bioequivalence studies are done for Early and late clinical trial formulations, Formulations used in clinical trial and stability studies,  if different Clinical trial formulations and to-be-marketed drug product When it comes to  cost and productivity metrics, it’s often said that what gets measured gets done. Bioequivalence is determined based on the bioavailability of the innovator medicine versus the generic medicine. A typical outline for a bioequivalence study includes organization of the test and reference items on two events to volunteer subjects, with every organization isolated by a washout period. This Study involves parameters on (Cmax) and (AUC), Statistical evaluation.

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.

  • Bioequivalence Protocols : In vitro-In vivo correlation
  • Dissolution Studies
  • Drug-release studies
  • Genetic Phenotyping
  • Response of clinical studies

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