ECU Libraries Catalog
Librarian View
LEADER 02228cam 2200457 a 4500
001
ocn400009435
003
OCoLC
005
20120912150042.0
006
m d f
007
cr b||||||||||
008
090615s2005 mdu ob f000 0 eng c
040
a| GPO
c| GPO
d| GPO
d| MvI
042
a| pcc
049
a| ERE#
074
a| 0499-T (online)
086
0
a| HE 20.4702:B 52/2
245
0
0
a| Guidance for industry :
b| Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process.
246
3
0
a| Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process
246
3
0
a| Comparability of biotechnological/biological products subject to changes in their manufacturing process
260
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| [2005]
300
a| 1 online resource (14 p.)
336
a| text
b| txt
2| rdacontent
337
a| computer
b| c
2| rdamedia
338
a| online resource
b| cr
2| rdacarrier
538
a| Mode of access: Internet at the FDA web site. Address as of 6/15/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128076.pdf ; current access is available via PURL.
500
a| Title from title screen (viewed on June 16, 2009).
500
a| "ICH".
500
a| "June 2005".
500
a| GPO Cataloging Record Distribution Program (CRDP).
504
a| Includes bibliographical references (p. 14).
650
0
a| Biotechnological process monitoring.
=| ^A856194
650
0
a| Pharmaceutical biotechnology.
=| ^A492454
650
0
a| Biological products.
=| ^A132664
611
2
0
a| International Conference on Harmonisation.
=| ^A998855
710
2
a| Center for Drug Evaluation and Research (U.S.)
=| ^A431016
710
2
a| Center for Biologics Evaluation and Research (U.S.)
=| ^A368272
856
4
0
u| https://purl.fdlp.gov/GPO/LPS113768
949
a| Click on web address
w| asis
h| joyner94
596
a| 1
998
a| 1900457
999
a| CLICK ON WEB ADDRESS
w| ASIS
c| 1
i| 1900457-1001
l| JNET
m| JOYNER
r| Y
s| Y
t| JNE1DO
u| 9/16/2009
x| EDOCUMENT
z| JERESOURCE
o| .STAFF. jlhb