Tema de trabajo aprobado
ISO/AWI TS 24830
Application of in-silico/read-across approaches for identifying a medical device constituent analogue
Reference number
ISO/AWI TS 24830
Edition 1
Tema de trabajo aprobado
ISO/AWI TS 24830
88203
Un grupo de trabajo ha preparado un borrador.

Resumen

This document specifies the process and provide guidance on how to justify and document the selection of appropriate read-across analogues to support the estimation of a point-of-departure (POD) in context of normative requirements in .This document also defines common terms used for read-across analysis.The document is applicable to describe the process required to support any toxicological risk assessment for which a relevant POD is missing.The document does not apply to selection of specific algorithms and computational tools. The process described in this document applies, and does not apply, to the same information or circumstances described in Clause 1 in ISO 10993-17.

Informaciones generales

  •  : En desarrollo
    : Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
  •  : 1
  • ISO/TC 194
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