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. 2016 Jan;18(1):15-22.
doi: 10.1208/s12248-015-9830-9. Epub 2015 Oct 1.

Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?

Dorys Argelia Diaz  1 , Stephen T Colgan  2 , Connie S Langer  2 , Nagesh T Bandi  3 , Michael D Likar  4 , Leslie Van Alstine  4
Affiliations

Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?

Dorys Argelia Diaz et al. AAPS J. 2016 Jan.

Erratum in

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.

Keywords: chemistry manufacturing and controls (CMC); comparative dissolution; f 2; global; regulatory; similarity factor.

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References

    1. Sathe P, Tsong Y, Shah P. In vitro dissolution profile comparison: statistics and analysis, model dependent approach. Pharm Res. 1996;13(12):1799–1803. doi: 10.1023/A:1016020822093. - DOI - PubMed
    1. Freitag G. Guidelines on dissolution profile comparison. Drug Inform J. 2001;35:865–874.
    1. Xie F, Ji S, Cheng Z. In vitro dissolution similarity factor (f2) and in vivo bioequivalence criteria, how and when do they match? using a BCS class II drug as a simulation example. Eur J Pharm Sci. 2015;66:163–172. doi: 10.1016/j.ejps.2014.10.002. - DOI - PubMed
    1. FDA Guidance for Industry. SUPAC-IR. Immediate release solid oral dosage forms. Scale-up and post approval changes. Chemistry, manufacturing and controls. In vitro dissolution testing and in vivo bioequivalence documentation. 1995.
    1. European Medicines Agency. Committee for medicinal products for human use. Guideline on the investigation of bioequivalence CPMP/EWP/QWP/1401/98 Rev.1/Corr**. 2010.

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