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13,267 articles

Original Research

Published on 20 Oct 2025

A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2

  • Alfredo García-Arieta
  • Andrew Tam
  • Florencia Tiseyra
  • Eduardo Agostinho Freitas Fernandes
  • Kelen Carine Costa Soares
  • Raphael Sanches Pereira
  • Henrike Potthast
  • Katalina Mettke
  • Ya-Wen Chang
  • Li-Feng Hsu
Journal of Pharmacy & Pharmaceutical Sciences
doi 10.3389/jpps.2025.14721