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001 ocn318815382;

003 OCoLC;

005 20090420160359.0;

006 m d f ;

007 cr a||||||||||;

008 090420s2008 mdu o f000 0 eng d;

040 a| GPOc| GPOd| MvI;

049 a| ERE#;

074 a| 0499-T-02 (online);

086 0 a| HE 20.4802:D 49/2;

245 00 a| E2f development safety update report.;

246 30 a| Development safety update report;

300 a| 33 p. :b| digital, PDF file;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

538 a| Mode of access: Internet at the FDA CDER Web site. Address as of 4/20/09: http://www.fda.gov/cder/guidance/8413dft.pdf ; current access is available via PURL.;

500 a| Title from PDF title page (viewed on Apr. 20, 2009).;

500 a| "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use"--PDF p.1.;

500 a| "ICH harmonised tripartite guideline"--PDF p. 1.;

500 a| "Draft"-- PDF p. 1.;

500 a| "Current step 2 version, 05 June 2008"--PDF p. 1.;

500 a| GPO Cataloging Record Distribution Program (CRDP).;

650 0 a| Drug developmentx| Evaluation.=| ^A443888;

710 2 a| Center for Drug Evaluation and Research (U.S.)=| ^A431016;

710 2 a| Center for Biologics Evaluation and Research (U.S.)=| ^A368272;

711 2 a| International Conference on Harmonisation.=| ^A998855;

856 40 u| https://purl.fdlp.gov/GPO/LPS111600;

949 a| Click on web addressw| asish| joyner94;

596 a| 1;

998 a| 1898048;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 1898048-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 9/11/2009x| EDOCUMENTz| JERESOURCEo| .STAFF. jlhb;

E2f development safety update report.

Other author	Center for Drug Evaluation and Research (U.S.)
Other author	Center for Biologics Evaluation and Research (U.S.)
Other author	International Conference on Harmonisation.
Format	Electronic
Publication Info	[Silver Spring, MD : Center for Drug Evaluation and Research ; Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2008]
Description	33 p. : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS111600
Subjects	Drug development--Evaluation.

Portion of title	Development safety update report
General note	Title from PDF title page (viewed on Apr. 20, 2009).
General note	"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use"--PDF p.1.
General note	"ICH harmonised tripartite guideline"--PDF p. 1.
General note	"Draft"-- PDF p. 1.
General note	"Current step 2 version, 05 June 2008"--PDF p. 1.
General note	GPO Cataloging Record Distribution Program (CRDP).
Technical details	Mode of access: Internet at the FDA CDER Web site. Address as of 4/20/09: http://www.fda.gov/cder/guidance/8413dft.pdf ; current access is available via PURL.
GPO item number	0499-T-02 (online)
Govt. docs number	HE 20.4802:D 49/2

E2f development safety update report.

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