Discussion of EMA Draft Guideline on Quality and Equivalence of Topical Products Based on Comparison of Approved Mometasone Furoate Drugs.
EMA draft guideline on quality and equivalence of topical products
In vitro penetration test (IVPT)
Mometasone furoate
Topical bioequivalence
Journal
Dermatology and therapy
ISSN: 2193-8210
Titre abrégé: Dermatol Ther (Heidelb)
Pays: Switzerland
ID NLM: 101590450
Informations de publication
Date de publication:
12 Jul 2024
12 Jul 2024
Historique:
received:
14
05
2024
accepted:
25
06
2024
medline:
13
7
2024
pubmed:
13
7
2024
entrez:
12
7
2024
Statut:
aheadofprint
Résumé
Today, the approval for a generic topical product includes the presentation of therapeutic equivalence to the originator based on clinical trials. To facilitate this procedure, in 2018 the European Medicines Agency (EMA) published a draft guideline on quality and equivalence of topical products, which includes request parameters regarding the quality of the newly developed generic product and test protocols for the implementation of equivalence tests regarding efficacy. To date, no data are available on the quality and evidence of the proposed test conditions. In this study, we performed an in vitro penetration test (IVPT) following the terms of the EMA draft guideline on two authorized topical products for which therapeutic equivalence was already proven during the approval process. The complex biometric data processing revealed that in vitro equivalence could not be observed for all skin sections for either originator or generic product. Moreover, the necessity of the negative control proposed in the draft guideline is more than questionable. From the results presented, there were indications that a reduced number of skin donors would be sufficient to achieve statistically significant equivalence in the comparison of all applied formulations. Here, n = 7 donors was proposed instead of n This bioequivalence study shows insufficient parameters, which should be discussed together with the EMA draft guideline.
Identifiants
pubmed: 38997617
doi: 10.1007/s13555-024-01222-z
pii: 10.1007/s13555-024-01222-z
doi:
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2024. The Author(s).
Références
European Medicines Agency (EMA). Concept paper on the development of product-specific guidance on demonstration of bioequivalence. 2013. https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-product-specific-guidance-demonstration-bioequivalence_en.pdf , Last accessed on 24 Jun 2024.
European Medicines Agency (EMA). Draft guideline on quality and equivalence of topical products. 2018. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-and-equivalence-topical-products_en.pdf , Last accessed on 24 Jun 2024.
Leal LB, et al. Bioequivalence methodologies for topical drug products: in vitro and ex vivo studies with a corticosteroid and an anti-fungal drug. Pharm Res. 2017;34(4):730–7.
doi: 10.1007/s11095-017-2099-1
pubmed: 28097506
pmcid: 5336544
Klein RR, et al. Development of an in vitro release test (IVRT) for a vaginal microbicide gel. Dissolut Technol. 2010;17:6–10.
doi: 10.14227/DT170410P6
Flaten GE, et al. In vitro skin models as a tool in optimization of drug formulation. Eur J Pharm Sci. 2015;75:10–24.
doi: 10.1016/j.ejps.2015.02.018
pubmed: 25746955
Franz TJ. Percutaneous absorption. On the relevance of in vitro data. J Investig Dermatol. 1975;64(3):190–5.
doi: 10.1111/1523-1747.ep12533356
pubmed: 123263
Franz TJ, Lehman PA, Raney SG. Use of excised human skin to assess the bioequivalence of topical products. Skin Pharmacol Physiol. 2009;22(5):276–86.
doi: 10.1159/000235828
pubmed: 19707043
pmcid: 2790798
Lehman PA, Franz TJ. Assessing topical bioavailability and bioequivalence: a comparison of the in vitro permeation test and the vasoconstrictor assay. Pharm Res. 2014;31(12):3529–37.
doi: 10.1007/s11095-014-1439-7
pubmed: 25005736
HMA—MRI Product Index. Product details Momecutan 1 mg/g Salbe. 2014. https://mri.cts-mrp.eu/portal/fulltext-search?term=momecutan , last accessed on 24 Jun 2024.
ICH - International council for harmonisation of technical requirements for pharmaceuticals for human use. ICH Q2(R2) Validation of analytical procedures - scientific guideline. 2022. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf , last accessed on 24 Jun 2024.
European Medicines Agency (EMA). Guideline on the investigation of bioequivalence. 2010. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf , last accessed on 24 Jun 2024.
U.S. Food And Drug Administration (FDA). In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs. 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/in-vitro-permeation-test-studies-topical-drug-products-submitted-andas , last accessed on 24 Jun 2024.
Praça FSG, et al. Evaluation of critical parameters for in vitro skin permeation and penetration studies using animal skin models. Eur J Pharm Sci. 2018;111:121–32.
doi: 10.1016/j.ejps.2017.09.034
pubmed: 28951120
Meidan VM, Roper CS. Inter- and intra-individual variability in human skin barrier function: a large scale retrospective study. Toxicol In Vitro. 2008;22(4):1062–9.
doi: 10.1016/j.tiv.2008.01.009
pubmed: 18321675
Health and Saftey Publications Organisation for Economic Cooperation and Development (OECD) Environment. Series on Testing and Assessment No. 156 - Guidance notes on dermal absorption. 2019. https://www.oecd.org/chemicalsafety/testing/48532204.pdf , last accessed on 24 Jun 2024.
Scientific Committee on Consumer Safety (SCCS). Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients. 2010. https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_002.pdf . Last accessed on 24 Jun 2024.