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040 a| GPOc| GPOd| MvI;

049 a| ERE#;

074 a| 0499-T (online);

086 0 a| HE 20.4702:L 11;

245 00 a| Guidance for industry :b| clinical lactation studies; study design, data analysis, and recommendations for labeling.;

246 30 a| Clinical lactation studies; study design, data analysis, and recommendations for labeling;

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 (19 p).;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

500 a| "Clinical pharmacology".;

500 a| "February 2005".;

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

504 a| Includes bibliographical references (p. 18-19).;

650 0 a| Lactation.=| ^A5735;

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 40 u| https://purl.fdlp.gov/GPO/LPS115955;

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

596 a| 1;

998 a| 2136342;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 2136342-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 10/21/2009x| EDOCUMENTz| JERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 2i| 2136342-1002l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 10/21/2009x| EDOCUMENTz| JERESOURCE;

Guidance for industry : clinical lactation studies; study design, data analysis, and recommendations for labeling.

Other author	Center for Drug Evaluation and Research (U.S.)
Other author	Center for Biologics Evaluation and Research (U.S.)
Format	Electronic
Publication Info	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
Description	1 online resource (19 p).
Supplemental Content	https://purl.fdlp.gov/GPO/LPS115955
Subjects	Lactation. Drugs--Labeling. --Government policy. --United States. Biologicals--Labeling. --Government policy. --United States.

Portion of title	Clinical lactation studies; study design, data analysis, and recommendations for labeling
General note	"Clinical pharmacology".
General note	"February 2005".
General note	GPO Cataloging Record Distribution Program (CRDP).
Bibliography note	Includes bibliographical references (p. 18-19).
GPO item number	0499-T (online)
Govt. docs number	HE 20.4702:L 11

Guidance for industry : clinical lactation studies; study design, data analysis, and recommendations for labeling.

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