Finding synergies for 3Rs - Toxicokinetics and read-across: Report from an EPAA partners' Forum.
Regul Toxicol Pharmacol
; 99: 5-21, 2018 Nov.
Article
em En
| MEDLINE
| ID: mdl-30144470
ABSTRACT
The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a Partners' Forum Toxicokinetics and Read-Across to provide an overview on research activities to develop in vitro toxicokinetics methods and physiologically-based kinetic (PBK) models and to find synergies to enhance use of toxicokinetic data to strengthen read-across. Currently, lacking toxicokinetic data often prevent the application of read-across. Preferably, toxicokinetic data should be generated using in vitro and in silico tools and anchored towards human relevance. In certain sectors, PBK modelling is being used for risk assessment, but less so in others. Specific activities were identified to facilitate the use of in vitro and in silico toxicokinetic data to support read-across The collation of available tools indicating the parameters and applicability domains covered; endpoint-specific guidance on toxicokinetics parameters required for read-across; case studies exemplifying how toxicokinetic data help support read-across. Activities to enhance the scientific robustness of read-across include the further user-friendly combination of read-across tools and formal guidance by the authorities specifying the minimum information requirements to justify read-across for a given toxicity endpoint. The EPAA was invited to continue dissemination activities and to explore possibilities to collate a contemporaneous list of open toxicokinetics tools that assist risk assessment.
Palavras-chave
Absorption; And elimination; Distribution; Excretion (ADME); Hazard and risk assessment; In vitro to in vivo extrapolation (IVIVE); Integrated approach for testing and assessment (IATA); Metabolism; Physiologically-based kinetic (PBK) modelling; Threshold of toxicological concern (TTC); Weight-of-evidence (WoE)
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Alternativas aos Testes com Animais
Tipo de estudo:
Diagnostic_studies
/
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Animals
/
Humans
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article