http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS)
Center for Biologics Evaluation and Research (U.S.)
Title from PDF title page (viewed on Apr. 24, 2009).
Mode of access: Internet at the FDA CBER Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/cmcsomcell.pdf ; current access is available via PURL.
Includes bibliographical references (pages 27-29).