Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?-Reference-Cited by-同舟云学术

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Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?

Published:2024-05 Issue: Volume:149 Page:105622
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Sündermann Jan^ORCID,Bitsch Annette,Kellner Rupert,Doll Theodor

Funder

Horizon 2020

Publisher

Elsevier BV

Reference44 articles.

1. Surface characterization of poly(methyl methacrylate) microgrooved for contact guidance of mammalian cells;Alaerts;Biomaterials,2001

2. Toward good read-across practice (GRAP) guidance;Ball;ALTEX,2016

3. Rheological and molecular weight comparisons of approved hyaluronic acid products - preliminary standards for establishing class III medical device equivalence;Braithwaite;J. Biomater. Sci. Polym. Ed.,2015

4. The new European medical device regulation: balancing innovation and patient safety;Bretthauer;Ann. Intern. Med.,2023

5. Upper and lower probability inferences based on a sample from a finite univariate population;Dempster;Biometrika,1967

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