4th Global Bioequivalence Harmonisation Conference Report has just been published

News of October 9th, 2021

In Dec 2019 GBHI conference took place in Bethesda, USA. Together with international regulatory authorities the following topics were discussed:

  • assessment of BE for long-acting injectables and implants
  • necessity of assessing BE for immediate-release (IR) dosage forms in the fed and/or fasted state,
  • current challenges for demonstration of therapeutic equivalence for orally inhaled drug products (OIDPs)

The open discussions help to better understand the intentions behind the guideline requirements and, most importantly, to anticipate future trends.

The Conference report is now available

All fine on single