Research Catalog

Guidance for industry : E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding catelgories.

Title
Guidance for industry : E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding catelgories.
Publication
Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008]

Available Online

https://purl.fdlp.gov/GPO/LPS111907

Details

Additional Authors
  • Center for Drug Evaluation and Research (U.S.)
  • Center for Biologics Evaluation and Research (U.S.)
  • International Conference on Harmonisation.
Description
i, 7 pages : digital, PDF file
Alternative Title
E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding catelgories
Subject
  • Genomics
  • Pharmacogenetics
  • Pharmacogenomics
Note
  • Title from PDF title page (viewed on Apr. 27, 2009).
  • "ICH".
  • "April 2008".
System Details (note)
  • Mode of access: Internet at the FDA CBER Web site. Address as of 4/27/09: http://www.fda.gov/cber/gdlns/iche15term.pdf ; current access is available via PURL.
Call Number
GPO Internet HE 20.4802:G 28/2
OCLC
marcive319434504
Title
Guidance for industry : E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding catelgories.
Publisher
Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008]
Type of Content
text
Type of Medium
computer
Type of Carrier
online resource
System Details
Mode of access: Internet at the FDA CBER Web site. Address as of 4/27/09: http://www.fda.gov/cber/gdlns/iche15term.pdf ; current access is available via PURL.
Connect to:
https://purl.fdlp.gov/GPO/LPS111907
Added Author
Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
International Conference on Harmonisation.
Gpo Item No.
0499-T-02 (online)
Sudoc No.
HE 20.4802:G 28/2
View in Legacy Catalog