Filling data gap for nicotinic acid, nicotinate esters and nicotinamide for the determination of permitted daily exposure by a category approach.

ABSTRACT: This study aimed to obtain necessary toxicological data using experimental and computational methods for the calculation of a common permitted daily exposure (PDE) which can be relevant for nicotinic acid and its esters and nicotinamide according to European Medicines Agency Guideline on setting health-based exposure limits. PDE calculation is mainly based on critical toxicological endpoints. During this procedure, critical toxicological endpoints data of an active pharmaceutical ingredient (API) may not be able to find satisfactorily. Hence, using toxicological data for another API that has a similar chemical structure can be a useful way. In this study, toxicological endpoints of nicotinic acid and its esters and nicotinamide were evaluated. Then, the data gaps in the toxicological endpo

SUBMITTER: Charehsaz M 

PROVIDER: S-EPMC8249511 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature