Open forum conference on the ICH M13A bioequivalence guideline


Blume H., Wedemeyer S., Seidlitz A., Beuerle G., Klein S., BİLENSOY E.

European Journal of Pharmaceutical Sciences, vol.196, 2024 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Review
  • Volume: 196
  • Publication Date: 2024
  • Doi Number: 10.1016/j.ejps.2024.106741
  • Journal Name: European Journal of Pharmaceutical Sciences
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, BIOSIS, CAB Abstracts, Chemical Abstracts Core, EMBASE, International Pharmaceutical Abstracts, MEDLINE, Veterinary Science Database, Directory of Open Access Journals
  • Keywords: Bioequivalence, Fasted and fed studies, ICH M13A draft guideline, Immediate release, pH-dependant solubility, Potency correction, Regulatory requirements
  • Hacettepe University Affiliated: Yes

Abstract

The Network on Bioavailability and Biopharmaceutics of EUFEPS (European Federation for Pharmaceutical Sciences) had organised an Open Discussion Forum on the ICH M13A draft “Guideline on bioequivalence for immediate-release solid oral dosage forms”. This conference was cosponsored by the Arbeitsgemeinschaft Pharmazeutische Verfahrenstechnik (APV) and the Frankfurt Foundation Quality of Medicines. Scientists from academia and industry attended this workshop on May 15, 2023, in Frankfurt/Germany, to discuss the suggested regulations with the European members of the ICH drafting group. The aim of this report is to summarise and highlight the main discussion points such as choice of study population (females and/or males), request for fasted and/or fed studies, consequences of differences in drug product content, handling of aberrant plasma profiles and additional requirements in case of pH-dependant solubility. During the discussion important arguments were presented for a revision of certain requirements suggested in the draft guideline.