Hussaarts L, Mühlebach S, Shah VP, McNeil S, Borchard G, Flühmann B, et al. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks. Ann N Y Acad Sci. 2017;1407(1):39–49.
Shah VP, Maibach HI, Jenner J. Topical drug bioavailability, bioequivalence, and penetration. Berlin: Springer; 2015.
Klein K, Borchard G, Shah VP, Flühmann B, McNeil SE, de Vlieger JSB. A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways. Ann N Y Acad Sci. 2021;1502(1):5–13.
Article PubMed PubMed Central Google Scholar
Lunawat S, Bhat K. Complex generic products: insight of current regulatory frameworks in US, EU and Canada and the need of harmonisation. Ther Innov Regul Sci. 2020;54(5):991–1000.
Holmgaard R, Benfeldt E, Bangsgaard N, Sorensen JA, Brosen K, Nielsen F, et al. Probe depth matters in dermal microdialysis sampling of benzoic acid after topical application: an ex vivo study in human skin. Skin Pharmacol Physiol. 2012;25(1):9–16.
Article CAS PubMed Google Scholar
Gaiser A, Lunter D. Investigation of the suitability of confocal Raman spectroscopy for the demonstration of bioequivalence of topical products. Int J Pharm. 2025;671:125214.
Article CAS PubMed Google Scholar
Cordery SF, Pensado A, Chiu WS, Shehab MZ, Bunge AL, Delgado-Charro MB, et al. Topical bioavailability of diclofenac from locally-acting, dermatological formulations. Int J Pharm. 2017;529(1–2):55–64.
Article CAS PubMed PubMed Central Google Scholar
Kasuga M, Kuwana K, Kuribayashi R. Regulation for the bioequivalence evaluation of generic topical dermatological drug products in Japan. Eur J Drug Metab Pharmacokinet. 2025;50(4):353–61.
Article CAS PubMed Google Scholar
Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol. 1987;123(10):1312–4.
Article CAS PubMed Google Scholar
Cornell RC, Stoughton RB. Correlation of the vasoconstriction assay and clinical activity in psoriasis. Arch Dermatol. 1985;121(1):63–7.
Article CAS PubMed Google Scholar
EMA. Guideline on quality and equivalence of locally applied, locally acting cutaneous products European Medicines Agency; 2024.
US-FDA. Draft guidance on topical dermatologic corticosteroids: In Vivo bioequivalence. U.S. Food and Drug Administration; 2023.
US-FDA. Guidance on residual drug in transdermal and related drug delivery systems. U.S. Food and Drug Administration; 2011.
Hadgraft J, Lane ME. Drug crystallization—implications for topical and transdermal delivery. Expert Opin Drug Deliv. 2016;13(6):817–30.
Article CAS PubMed Google Scholar
Lazar M, Zhang AD, Vashi NA. Topical treatments in atopic dermatitis: an expansive review. J Clin Med. 2024;13(8).
Alves C, Penedones A, Mendes D, Batel Marques F. Topical Janus kinase inhibitors in atopic dermatitis: a safety network meta-analysis. Int J Clin Pharm. 2023;45(4):830–8.
Article CAS PubMed PubMed Central Google Scholar
Montero-Vilchez T, Segura-Fernández-Nogueras MV, Pérez-Rodríguez I, Soler-Gongora M, Martinez-Lopez A, Fernández-González A et al. Skin barrier function in psoriasis and atopic dermatitis: transepidermal water loss and temperature as useful tools to assess disease severity. J Clin Med. 2021;10(2).
Feingold KR. Thematic review series: skin lipids. The role of epidermal lipids in cutaneous permeability barrier homeostasis. J Lipid Res. 2007;48(12):2531–46.
Article CAS PubMed Google Scholar
Jin X, Imran M, Mohammed Y. Topical semisolid products-understanding the impact of metamorphosis on skin penetration and physicochemical properties. Pharmaceutics. 2022;14(11).
OECD. Test No. 428: Skin Absorption: In Vitro Method. 2004.
OECD. Test No. 427: Skin Absorption: In Vivo Method. 2004.
Agency EM. Guideline on quality and equivalence of locally applied, locally acting cutaneous products. EMA; 2024.
Lourenço D, Miranda M, Sousa JJ, Vitorino C. Therapeutic-driven framework for bioequivalence assessment of complex topical generic drug products. Int J Pharm. 2024;661:124398.
US-FDA. Draft Guidance for Industry: Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs. 2022.
Baumann KY, Church MK, Clough GF, Quist SR, Schmelz M, Skov PS, et al. Skin microdialysis: methods, applications and future opportunities-an EAACI position paper. Clin Transl Allergy. 2019;9:24.
Ault JM, Riley CM, Meltzer NM, Lunte CE. Dermal microdialysis sampling in vivo. Pharm Res. 1994;11(11):1631–9.
Article CAS PubMed Google Scholar
Darvin ME. Optical methods for non-invasive determination of skin penetration: current trends, advances, possibilities, prospects, and translation into in vivo human studies. Pharmaceutics. 2023;15(9).
Pena AM, Chen X, Pence IJ, Bornschlögl T, Jeong S, Grégoire S, et al. Imaging and quantifying drug delivery in skin—part 2: fluorescence andvibrational spectroscopic imaging methods. Adv Drug Deliv Rev. 2020;153:147–68.
Comments (0)