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| 001 |
in00002490878 |
| 005 |
20211202191451.0 |
| 006 |
m d f |
| 007 |
cr bn||||||||| |
| 008 |
090424s2008 mdu ob f000 0 eng c |
| 035 |
|
|
|a (OCoLC)ocn319178291
|
| 040 |
|
|
|a GPO
|c GPO
|d GPO
|d MvI
|d UtOrBLW
|
| 042 |
|
|
|a pcc
|
| 049 |
|
|
|a WWW
|
| 074 |
|
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|a 0499-T-02 (online)
|
| 086 |
0 |
|
|a HE 20.4802:C 42/2
|
| 245 |
0 |
0 |
|a Guidance for FDA reviews and sponsors :
|b content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs).
|
| 246 |
3 |
0 |
|a Content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
|
| 264 |
|
1 |
|a Rockville, MD :
|b U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,
|c [2008]
|
| 300 |
|
|
|a 1 online resource (ii, 34 pages)
|
| 336 |
|
|
|a text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a computer
|b c
|2 rdamedia
|
| 338 |
|
|
|a online resource
|b cr
|2 rdacarrier
|
| 500 |
|
|
|a Title from PDF title page (viewed on Apr. 24, 2009).
|
| 538 |
|
|
|a Mode of access: Internet at the GPO Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/gtindcmc.pdf ; current access is available via PURL.
|
| 500 |
|
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|a Title from title screen (viewed on Apr. 24, 2009).
|
| 500 |
|
|
|a "April 2008".
|
| 504 |
|
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|a Includes bibliographical references (pages 32-34).
|
| 500 |
|
|
|a Electronic resource.
|
| 650 |
|
0 |
|a Gene therapy.
|
| 650 |
|
0 |
|a Drug approval
|z United States.
|
| 710 |
2 |
|
|a Center for Biologics Evaluation and Research (U.S.)
|
| 856 |
4 |
0 |
|u https://purl.fdlp.gov/GPO/LPS111884
|t 0
|
| 999 |
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|a MARS
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| 999 |
f |
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|i af677325-ee93-3d80-9ecb-5ad413644c2c
|t 0
|
| 952 |
f |
f |
|a Texas A&M University
|b College Station
|c Electronic Resources
|d Available Online
|t 0
|e HE 20.4802:C 42/2
|h Superintendent of Documents classification
|
| 998 |
f |
f |
|a HE 20.4802:C 42/2
|t 0
|l Available Online
|