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040 a| GPOc| GPOd| MvI;

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074 a| 0475 (online);

086 0 a| HE 20.4002:SA 1/8;

245 00 a| Post-approval safety data management :b| definitions and standards for expedited reporting.;

246 30 a| Definitions and standards for expedited reporting;

260 a| [Rockville, Md.? :b| U.S. Dept. of Health and Human Services, Food and Drug Administration,c| 2003];

300 a| 12 :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 web site. Address as of 6/19/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129458.pdf ; current access is available via PURL.;

500 a| Title from PDF title page (viewed on June 19, 2009).;

500 a| "ICH harmonised tripartite guideline draft".;

500 a| "Recommended for adoption at step 2 of the ICH process on July 19, 2003 by the ICH Steering Committee".;

500 a| "ICH E2E ver. 3.8".;

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

650 0 a| Drugsx| Side effectsx| Reporting.=| ^A888184;

650 0 a| Clinical pharmacology.=| ^A807728;

710 1 a| United States.b| Food and Drug Administration.=| ^A1253;

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

856 40 u| https://purl.fdlp.gov/GPO/LPS113940;

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

596 a| 1;

998 a| 1900595;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 1900595-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 9/16/2009x| EDOCUMENTz| JERESOURCEo| .STAFF. jlhb;

Post-approval safety data management : definitions and standards for expedited reporting.

Other author	United States. Food and Drug Administration.
Other author	International Conference on Harmonisation.
Format	Electronic
Publication Info	[Rockville, Md.? : U.S. Dept. of Health and Human Services, Food and Drug Administration, 2003]
Description	12 : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS113940
Subjects	Drugs--Side effects. --Reporting. Clinical pharmacology.

Portion of title	Definitions and standards for expedited reporting
General note	Title from PDF title page (viewed on June 19, 2009).
General note	"ICH harmonised tripartite guideline draft".
General note	"Recommended for adoption at step 2 of the ICH process on July 19, 2003 by the ICH Steering Committee".
General note	"ICH E2E ver. 3.8".
General note	GPO Cataloging Record Distribution Program (CRDP).
Technical details	Mode of access: Internet at the FDA web site. Address as of 6/19/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129458.pdf ; current access is available via PURL.
GPO item number	0475 (online)
Govt. docs number	HE 20.4002:SA 1/8

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Post-approval safety data management : definitions and standards for expedited reporting.

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