Towards understanding interchangeability of generic drugs

Yang Yu

Research output: ThesisDoctoral ThesisInternal

1551 Downloads (Pure)

Abstract

Registered generic drugs are considered interchangeable with brand-name drugs. However, concerns still exist in practice. In this dissertation, the role of individual-subject variation in the drug absorption and the effect of post-marketing drug quality changes were studied for generic and the brand-name drug interchangeability. Generic-generic drug interchangeability was studied in a clinical trial and inter-study comparisons. In conclusion, interchanges of generic to the brand-name drugs or generic to other generic drugs can be applied in clinical practice without clinical consequences. Current regulation for registration of a generic drug in Europe is reasonably strict to ensure the bioequivalence of the generic drug with the brand-name drug.
Original languageEnglish
Awarding Institution
  • Maastricht University
Supervisors/Advisors
  • Neef, Kees, Supervisor
  • Burger, D. , Supervisor, External person
  • Maliepaard, M., Advisor, External person
Award date19 May 2017
Place of PublicationMaastricht
Publisher
Print ISBNs9789461596833
DOIs
Publication statusPublished - 2017

Keywords

  • generic drug
  • brand-name drug
  • interchangeability
  • bioequivalence

Cite this