Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization

Suarez S, Abend A, Hoffelder T, Leblond D, Delvadia P, Kovacs E, et al. In vitro dissolution profiles similarity assessment in support of drug product quality: what, how, when—workshop summary report. AAPS J. 2020;22(4):74.

Hoffelder T, Leblond D, Van Alstine L, Diaz DA, Suarez-Sharp S, Witkowski K, et al. Dissolution profile similarity analyses-statistical principles, methods and considerations. AAPS J. 2022;24(3):54.

Article  CAS  PubMed  Google Scholar 

Abend A, Zhang L, Fredro-Kumbaradzi E, Hoffelder T, Cohen M, Anand O, et al. Current approaches for dissolution similarity assessment, requirements, and global expectations. AAPS J. 2022;24(3):50.

Nosal R. The Value of Similarity Testing in Drug Product Development. In: In vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality Workshop. Baltimore, MD; 2019. Available at: https://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/dissolution-similarity/nosal-slides.pdf.

European Medicines Agency. Committee for medicinal products for human use. Guideline on the investigation of bioequivalence CPMP/EWP/QWP/1401/98 Rev.1/Corr**. EMA guidance. 2010. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf

U.S. Department of Health and Human Services - Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry - dissolution testing of immediate release solid oral dosage forms. FDA; 1997. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dissolution-testing-immediate-release-solid-oral-dosage-forms.

Pereira VG. ANVISA’s current practice and challenges in the evaluation of dissolution profile comparisons in support of minor/moderate product quality changes: case studies. In: In vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality Workshop. Baltimore, MD; 2019. Available at: https://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/dissolution-similarity/pereira-slides.pdf.

Lum S. Health Canada’s current practice and challenges in the evaluation of dissolution profile comparisons in support of minor/moderate product quality changes: case studies. In: In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality Workshop. Baltimore, MD; 2019. Available at: https://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/dissolution-similarity/lum-slides_revised.pdf.

Abend A, Heimbach T, Cohen M, Kesisoglou F, Pepin X, Suarez S. Dissolution and translational modeling strategies enabling patient-centric drug product development: M-CERSI workshop summary report. AAPS J. 2018;20(3):60.

Article  PubMed  Google Scholar 

Suarez-Sharp S, Cohen M, Kesisoglou F, Abend A, Marroum P, Delvadia P, et al. Applications of clinically relevant dissolution testing: workshop summary report. AAPS Journal. 2018;20(6):93.

Article  PubMed  Google Scholar 

Davit B, Braddy AC, Conner DP, Yu LX. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences. AAPS J. 2013;15(4):974–90.

Article  PubMed  PubMed Central  Google Scholar 

Davit BM, Kanfer I, Tsang YC, Cardot J-M. BCS biowaivers: similarities and differences among EMA, FDA, and WHO requirements. AAPS J. 2016;18(3):612–8.

Article  PubMed  PubMed Central  Google Scholar 

Diaz DA, Colgan ST, Langer CS, Bandi NT, Likar MD, Van Alstine L. Dissolution similarity requirements: how similar or dissimilar are the global regulatory expectations? AAPS J. 2016;18(1):15–22.

Article  PubMed  Google Scholar 

Van Oudtshoorn JE, García-Arieta A, Santos GML, Crane C, Rodrigues C, Simon C, et al. A survey of the regulatory requirements for BCS-based biowaivers for solid oral dosage forms by participating regulators and organisations of the International Generic Drug Regulators Programme. J Pharm Pharm Sci. 2018;21(1):27–37.

Article  CAS  PubMed  Google Scholar 

Hermans A, Abend A, Kesisoglou F, Flanagan T, Cohen MJ, Diaz DA, et al. Approaches for establishing clinically relevant dissolution specifications during drug development. AAPS J. 2017;19(6):1537–49.

Article  CAS  PubMed  Google Scholar 

Mandula H. Rational statistical analysis practice in dissolution profile comparison: FDA perspective. In: In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality Workshop. Baltimore, MD; 2019. Available at: https://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/dissolution-similarity/mandula-slides.pdf.

U.S. Department of Health and Human Services - Food and Drug Administration, Center for Drug Evaluation and Research (CDER). The use of physiologically based pharmacokinetic analyses — biopharmaceutics applications for oral drug product development, manufacturing changes, and controls, draft guidance for industry. FDA; 2020. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-physiologically-based-pharmacokinetic-analyses-biopharmaceutics-applications-oral-drug-product.

FDA. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use. Biopharmaceutics Classification System-based Biowaivers M9. 2019. Available at: https://database.ich.org/sites/default/files/M9_Guideline_Step4_2019_1116.pdf.

U.S. Department of Health and Human Services - Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Bioavailability Studies Submitted in NDAs or INDs — General Considerations. FDA; 2022. Available at: https://www.fda.gov/media/121311/download.

Altan S. Weibull model approach for similarity testing, preformance and limitations. In: In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality Workshop. Baltimore, MD; 2019. Available at: https://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/dissolution-similarity/altan-slides.pdf.

Wellek S. Testing statistical hypotheses of equivalence and noninferiority, 2nd edn. Boca Raton: Chapman & Hall/CRC; 2010.

Suarez-Sharp S, Abend A, Hoffelder T, Leblond D, Delvadia P, Kovacs E, et al. In vitro dissolution profiles similarity assessment in support of drug product quality: what, how, when-workshop summary report. AAPS J. 2020;22(4):74.

Article  PubMed  Google Scholar 

Siewert M. FIP Guidelines for dissolution testing of solid oral products. Pharm Ind. 1995;57:362–9.

Google Scholar 

Abend A, Curran D, Kuiper J, Lu X, Li H, Hermans A, et al. Dissolution testing in drug product development: workshop summary report. AAPS J. 2019;21(2):21.

Marroum PJ. Clinically relevant dissolution methods and specifications. Am Pharm Rev. 2012;15(1):36–41.

CAS  Google Scholar 

U.S. Department of Health and Human Services - Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. FDA; 1997. Available at: https://www.fda.gov/media/70939/download.

Kesisoglou F, Hermans A, Neu C, Yee KL, Palcza J, Miller J. Development of in vitro-in vivo correlation for amorphous solid dispersion immediate-release suvorexant tablets and application to clinically relevant dissolution specifications and in-process controls. J Pharm Sci. 2015;104(9):2913–22.

Article  CAS  PubMed  Google Scholar 

Davit B. Establishing clinical relevant specifications during product life cycle: case studies. In: Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development Workshop. Baltimore, MD; 2017. Available at: https://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/dissolution/day3_barbara-davit.pdf.

Pepin XJH. In silico PBPK modelling in support of drug product dissolution and drug substance particle size specifications. In: Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development Workshop. Baltimore, MD; 2017. Available at: https://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/dissolution/day2_xavier-pepin.pdf.

Pepin XJH, Flanagan TR, Holt DJ, Eidelman A, Treacy D, Rowlings CE. Justification of drug product dissolution rate and drug substance particle size specifications based on absorption PBPK modeling for lesinurad immediate release tablets. Mol Pharm. 2016;13(9):3256–69.

Article  CAS  PubMed  Google Scholar 

Heimbach T, Suarez-Sharp S, Kakhi M, Holmstock N, Olivares-Morales A, Pepin X, et al. Dissolution and translational modeling strategies toward establishing an in vitro-in vivo link—a workshop summary report. AAPS J. 2019;21(2):29.

Article  PubMed  Google Scholar 

Pepin XJH, Parrott N, Dressman J, Delvadia P, Mitra A, Zhang X, et al. Current state and future expectations of translational modeling strategies to support drug product development, manufacturing changes and controls: a workshop summary report. J Pharm Sci. 2021;110(2):555–66.

Article  CAS  PubMed  Google Scholar 

Laisney M, Heimbach T, Mueller-Zsigmondy M, Blumenstein L, Costa R, Ji Y. Physiologically based biopharmaceutics modeling to demonstrate virtual bioequivalence and bioequivalence safe-space for ribociclib which has permeation rate-controlled absorption. J Pharm Sci. 2022;111(1):274–84.

Article  CAS  PubMed  Google Scholar 

Pharmaceutical and Medicinal Product Agency (Japan). Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms. In: Ministry of Health and Welfare J, editors. Yakuji Nippo Ltd.; 2020. Available at: https://www.nihs.go.jp/drug/be-guide(e)/2020/GL3_formation_changes_2020.pdf.

Pharmaceutics and Medical Device Agency (PMDA). Guideline for bioequivalence studies of generic products. In: Ministry of Health and Welfare J, editor. Yakuji Nippo Ltd.; 2020. Available at: https://www.nihs.go.jp/drug/be-guide(e)/2020/GL1_BE_2020.pdf.

United States Pharmacopeia and the National Formulary (USP-NF). Chapter 711 Dissolution. Rockville; US Pharmacopeial Convention; 2022. Available at: https://www.uspnf.com/notices/711-dissolution-nitr-20220527.

Koziolek M, Grimm M, Becker D, Iordanov V, Zhou H, Shimizu J, et al. Investigation of pH and temperature profiles in the GI tract of fasted human subjects using the Intellicap® system. J Pharm Sci. 2015;104:2855–63.

CAS  Google Scholar 

Kambayashi A, Blume H, Dressman J. Understanding the in vivo performance of enteric coated tablets using an in vitro-in silico-in vivo approach: case example diclofenac. Eur J Pharm Biopharm. 2013;85:1337–47.

Article  CAS  PubMed  Google Scholar 

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