Bioequivalence assessment of pharmaceutical aerosol products through IVIVC

Autor:	Dennis Sandell
Rok vydání:	2021
Předmět:	Aerosols IVIVC Drug Development Pharmaceutical Preparations Therapeutic Equivalency Computer science Drug Evaluation Preclinical Humans Pharmaceutical Science Pharmacokinetics Biochemical engineering Bioequivalence Models Biological
Zdroj:	Advanced Drug Delivery Reviews. 176:113895
ISSN:	0169-409X
DOI:	10.1016/j.addr.2021.113895
Popis:	Many pharmaceutical developers of generic orally inhaled products (OIPs) are facing significant issues in passing the regulatory requirement to show pharmacokinetic (PK) bioequivalence (BE) to the originator product. The core of the issue is that no reliable in vitro-in vivo correlation (IVIVC) is available to guide their development. In this paper, several issues are identified and means to improve the data used for developing an IVIVC are discussed. The article also presents an "IVIVC-free" approach for developing a formulation matching the originator's PK performance.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f31a66bc2da4380b0f9db01a4992be67 https://doi.org/10.1016/j.addr.2021.113895 Zobrazit plný text záznamu Full Text from ScienceDirect