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LEADER |
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|a (OCoLC)ocn422635611
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|a GPO
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|a WWW
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|a 0499-T (online)
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|a HE 20.4702:OR 3
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245 |
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|a Guidance for industry :
|b M4, organization of the CTD.
|
246 |
3 |
0 |
|a M4, organization of the CTD
|
264 |
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1 |
|a Rockville, MD :
|b U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
|b Center for Biologics Evaluation and Research,
|c [2001]
|
300 |
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|a 7 pages :
|b digital, PDF file.
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|a text
|b txt
|2 rdacontent
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|a computer
|b c
|2 rdamedia
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|a online resource
|b cr
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|a Mode of access: Internet at the FDA web site. Address as of 7/6/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129873.pdf ; current access is available via PURL.
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500 |
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|a Title from PDF title page (viewed on July 6, 2009).
|
500 |
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|a "ICH".
|
500 |
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|a "August 2001".
|
500 |
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|a Electronic resource.
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650 |
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|a Drug approval
|x Government policy
|z United States.
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710 |
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|a Center for Drug Evaluation and Research (U.S.)
|
710 |
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|a Center for Biologics Evaluation and Research (U.S.)
|
711 |
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|a International Conference on Harmonisation.
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|a Texas A&M University
|b College Station
|c Electronic Resources
|d Available Online
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|e HE 20.4702:OR 3
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998 |
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