The Need for Non-Human Primates in Biomedical Research, Production and Testing of Products and Devices (Update 2017)

Published by EC

Non-Human Primate Model

EU opinon and legilastion on the suse of Non-human Primate in Biomedical Research. The European Commission strongly advocates the “3Rs principle”. now a legal obligation embedded in the EU legislation to: Replace non-human primates with viable alternatives whenever feasible, Reduce the use of non-human primates and Refine scientific procedures and the care and treatment of the animals

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The NIGMS Human Genetic Cell Repository

Published by NIGMS

Cell RepositoryiPS Cell Line

The NIGMS Human Genetic Cell Repository is a collection of well-characterized, high-quality human cells for use in biomedical research. Established by NIGMS in 1972 and housed at the Coriell Institute for Medical Research in Camden, New Jersey, the repository contains more than 11,300 cell lines and 5,700 DNA samples derived from them. The specimens, which are equally divided between those from males and those from females, were acquired from individuals with inherited diseases, apparently healthy individuals and individuals of diverse geographic origins. Almost 900 diseases and 40-plus population groups are currently represented in the repository. It also includes a collection of induced pluripotent stem (iPS) cell lines that carry disease gene mutations or are normal control iPS cell lines

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This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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