Drug Delivery System
Online ISSN : 1881-2732
Print ISSN : 0913-5006
ISSN-L : 0913-5006
Feature articles “Development of new technologies toward the clinical trials of gene therapy” Editor : Mahito Nakanishi
Quality control and safety of human cell therapy products
Teruhide YamaguchiEriko Uchida
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2007 Volume 22 Issue 6 Pages 651-659

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Abstract
ICH gene therapy discussion group has been expected to exchange information with the following objectives:monitoring emerging scientific issues, developing new ways of communication to ensure that the outcomes of ICH are well understood and widely disseminated, proactively setting out principles that may have a beneficial impact on harmonizing regulation of gene therapy products. The group has been discussing and published the concept papers about reference materials for gene therapy vectors, virus/vector shedding, evaluation of risk of X-SCID gene therapy, oncolytic virus products, and risk of germline integration of gene therapy products.
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© 2007 Japan Society of Drug Delivery System
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