The implications of regulatory framework for topical semisolid drug products: From critical quality and performance attributes towards establishing bioequivalence
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Due 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 pharmaceut...ical 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.
Ključne reči:
Equivalence with respect to efficacy / Extended pharmaceutical equivalence / Generic semisolid drug product / In vitro permeation testing / In vitro release testing / Microstructure / Qualitative and quantitative composition / Tape strippingIzvor:
Pharmaceutics, 2021, 13, 5Izdavač:
- MDPI AG
Finansiranje / projekti:
DOI: 10.3390/pharmaceutics13050710
ISSN: 1999-4923
WoS: 000662436800001
Scopus: 2-s2.0-85106874541
Institucija/grupa
PharmacyTY - JOUR AU - Ilić, Tanja AU - Pantelić, Ivana AU - Savić, Snežana PY - 2021 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3906 AB - Due 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. PB - MDPI AG T2 - Pharmaceutics T1 - The implications of regulatory framework for topical semisolid drug products: From critical quality and performance attributes towards establishing bioequivalence VL - 13 IS - 5 DO - 10.3390/pharmaceutics13050710 ER -
@article{ author = "Ilić, Tanja and Pantelić, Ivana and Savić, Snežana", year = "2021", abstract = "Due 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.", publisher = "MDPI AG", journal = "Pharmaceutics", title = "The implications of regulatory framework for topical semisolid drug products: From critical quality and performance attributes towards establishing bioequivalence", volume = "13", number = "5", doi = "10.3390/pharmaceutics13050710" }
Ilić, T., Pantelić, I.,& Savić, S.. (2021). The implications of regulatory framework for topical semisolid drug products: From critical quality and performance attributes towards establishing bioequivalence. in Pharmaceutics MDPI AG., 13(5). https://doi.org/10.3390/pharmaceutics13050710
Ilić T, Pantelić I, Savić S. The implications of regulatory framework for topical semisolid drug products: From critical quality and performance attributes towards establishing bioequivalence. in Pharmaceutics. 2021;13(5). doi:10.3390/pharmaceutics13050710 .
Ilić, Tanja, Pantelić, Ivana, Savić, Snežana, "The implications of regulatory framework for topical semisolid drug products: From critical quality and performance attributes towards establishing bioequivalence" in Pharmaceutics, 13, no. 5 (2021), https://doi.org/10.3390/pharmaceutics13050710 . .