水曜日, 11月 29, 0018

EMEA ICH related document

ICH関連でいくつかEMEAから出ました:
28/11/06 Note for Guidance on establishing definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories
http://www.emea.europa.eu/pdfs/human/ich/43798606en.pdf

28/11/06 Updated Questions & Answers - Common Technical Document for the Registration of Pharmaceuticals for Human Use
http://www.emea.europa.eu/pdfs/human/ich/082006en.pdf

27/11/06 ICH Considerations - General principles to address the risk of inadvertent germline integration of gene therapy vectors
http://www.emea.europa.eu/pdfs/human/ich/46999106en.pdf

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