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dc.creatorIlić, Tanja
dc.creatorPantelić, Ivana
dc.creatorSavić, Snežana
dc.date.accessioned2021-06-08T08:07:56Z
dc.date.available2021-06-08T08:07:56Z
dc.date.issued2021
dc.identifier.issn1999-4923
dc.identifier.urihttps://farfar.pharmacy.bg.ac.rs/handle/123456789/3906
dc.description.abstractDue to complex interdependent relationships affecting their microstructure, topical semisolid drug formulations face unique obstacles to the development of generics compared to other drug products. Traditionally, establishing bioequivalence is based on comparative clinical trials, which are expensive and often associated with high degrees of variability and low sensitivity in detecting formulation differences. To address this issue, leading regulatory agencies have aimed to advance guidelines relevant to topical generics, ultimately accepting different non-clinical, in vitro/in vivo surrogate methods for topical bioequivalence assessment. Unfortunately, according to both industry and academia stakeholders, these efforts are far from flawless, and often upsurge the potential for result variability and a number of other failure modes. This paper offers a comprehensive review of the literature focused on amending regulatory positions concerning the demonstration of (i) extended pharmaceutical equivalence and (ii) equivalence with respect to the efficacy of topical semisolids. The proposed corrective measures are disclosed and critically discussed, as they span from mere demands to widen the acceptance range (e.g., from 10% to 20%/25% for rheology and in vitro release parameters highly prone to batch-to-batch variability) or reassess the optimal number of samples required to reach the desired statistical power, but also rely on specific data modeling or novel statistical approaches.
dc.publisherMDPI AG
dc.relationinfo:eu-repo/grantAgreement/MESTD/inst-2020/200161/RS//
dc.rightsopenAccess
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.sourcePharmaceutics
dc.subjectEquivalence with respect to efficacy
dc.subjectExtended pharmaceutical equivalence
dc.subjectGeneric semisolid drug product
dc.subjectIn vitro permeation testing
dc.subjectIn vitro release testing
dc.subjectMicrostructure
dc.subjectQualitative and quantitative composition
dc.subjectTape stripping
dc.titleThe implications of regulatory framework for topical semisolid drug products: From critical quality and performance attributes towards establishing bioequivalence
dc.typearticle
dc.rights.licenseBY
dcterms.abstractСавић, Снежана; Илић, Тања; Пантелић, Ивана;
dc.citation.volume13
dc.citation.issue5
dc.citation.rankM21
dc.identifier.wos000662436800001
dc.identifier.doi10.3390/pharmaceutics13050710
dc.identifier.scopus2-s2.0-85106874541
dc.identifier.fulltexthttps://farfar.pharmacy.bg.ac.rs/bitstream/id/8995/The_Implications_of_pub_2021.pdf
dc.type.versionpublishedVersion


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Приказ основних података о документу