title: Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?
abstract: The objective of this article is to compare and contrast the international expectations associated with the model-independent similarity factor approach to comparing dissolution profiles. This comparison highlights globally divergent regulatory requirements to meet local dissolution similarity requirements. In effect, experiments customized to meet the current international regulatory expectations for dissolution and drug release unnecessarily increase manufacturing costs, hinder science and risk-based approaches, increase collective regulatory burden, reduce continuous improvement and innovation, and potentially delay patient access to urgently needed medication. Comparative assessment of regulatory differences in applying dissolution to demonstrate product similarity is crucial to reduce non-scientifically justified experiments and foster collaborative harmonization among global regulatory health authorities and the pharmaceutical industry.
authors.affiliation: Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA. dorys.argelia.diaz@pfizer.com.
authors.forename: Dorys Argelia
authors.initials: DA
authors.lastname: Diaz
authors.affiliation: Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA.
authors.forename: Stephen T
authors.initials: ST
authors.lastname: Colgan
authors.affiliation: Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA.
authors.forename: Connie S
authors.initials: CS
authors.lastname: Langer
authors.affiliation: Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc, 100 Route 206 North, Peapack, New Jersey, 07977, USA.
authors.forename: Nagesh T
authors.initials: NT
authors.lastname: Bandi
authors.affiliation: Worldwide Research and Development, Analytical Research and Development, Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Likar
authors.affiliation: Worldwide Research and Development, Analytical Research and Development, Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA.
authors.forename: Leslie
authors.initials: L
authors.lastname: Van Alstine
mesh_terms: D000465:Algorithms; D002626:Chemistry, Pharmaceutical / Q000592:standards*; D004345:Drug Industry / Q000592:standards; D005062:European Union; D006801:Humans; D007391:International Cooperation; D007880:Legislation, Drug; D012995:Solubility; D014481:United States
keywords: chemistry manufacturing and controls (CMC); comparative dissolution; f 2; global; regulatory; similarity factor