Therapeutic-driven framework for bioequivalence assessment of complex topical generic drug products.
Int J Pharm
; 661: 124398, 2024 Aug 15.
Article
en En
| MEDLINE
| ID: mdl-38964491
ABSTRACT
Despite the continuous research on understanding how topical drugs and the skin interact, the development of a topical generic product remains a challenge. Due to their local action effect rather than systemic, establishing suitable frameworks for documenting bioequivalence between reference and test formulations is anything but straightforward. In previous years, clinical endpoint trials were considered the gold standard method to demonstrate bioequivalence between topical products. Nevertheless, significant financial and time resources were required to be allocated owing to the inherent complexity of these studies. To address this problem, regulatory authorities have begun to accept alternative approaches that could lead to a biowaiver, avoiding the need for clinical endpoint trials. These alternatives encompass various in vitro and/or in vivo techniques that have been analysed and the benefits and drawbacks of each method have been considered. Furthermore, other factors like the integration of a quality by design framework to ensure a comprehensive understanding of the product and process quality attributes have also been taken into account. This review delves into international regulatory recommendations for semisolid topical products, with a focus on those established by the European Medicines Agency, as well as the Food and Drug Administration. Both approaches were carefully examined, discussing aspects such as acceptance criteria, sample size, and microstructure evaluation. Additionally, novel and innovative therapeutic-driven approaches based on in vitro disease models for the rapid and effective development of topical generic products are presented.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Equivalencia Terapéutica
/
Administración Tópica
/
Medicamentos Genéricos
Límite:
Animals
/
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Int J Pharm
Año:
2024
Tipo del documento:
Article
País de afiliación:
Portugal
Pais de publicación:
Países Bajos