BE Studies and Assessment

BE 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 productivitymetrics, it’s often said that what gets measured gets done. Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. 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.

  • Drug-release studies
  • Bioequivalence Protocols : In vitro-In vivo correlation
  • Dissolution Studies
  • Genetic Phenotyping
  • Response of clinical studies
  • BE of Narrow Therapeutic Index Drugs
  • BE of Endogenous substances
  • BE testing-Geographical considerations
  • Documented standard operating procedures
  • BE-Highly variable drugs and drug products
  • BE -Strategies
  • BE assessment of IR and MR products
  • Alcoholic Beverage Effects on MR Drug Products
  • Analysis of BA/BE by Oral vs Parenteral

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