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1
Guidance for industry : Q3A impurities in new drug substances.
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, 2008

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Government Document Conference Proceeding Book
2
Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER), 2008

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Government Document Conference Proceeding Book
3
Guidance for industry : E 10 choice of control group and related issues in clinical trials.
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, 2001

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Government Document Conference Proceeding Book
4
Guidance for industry : E 10 choice of control group and related issues in clinical trials.
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, 2001

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Government Document Conference Proceeding Book
5
Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter.
Silver Spring, MD : Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Center for Biologics Evaluation and Research (CBER), 2009

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Government Document Conference Proceeding Book
6
Guidance for industry M2 : eCTD specification : questions & answers and change requests.
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

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Government Document Conference Proceeding Book
7
Guidance for industry : Q3A impurities in new drug substances.
Sliver Spring, MD : 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, 2008

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Government Document Conference Proceeding Book
8
Guidance for industry Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter.

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Government Document Electronic Conference Proceeding Book
9
Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions annex 5, disintegration test general chapter.
[Silver Spring, MD : [Rockville, MD : Center for Drug Evaluation and Research ; U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2008

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Government Document Electronic Conference Proceeding Book
10
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for Extractable Volume of Parenteral Preparations General Chapter.

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Government Document Electronic Conference Proceeding Book
11
Guidance for industry : Q3C tables and list.
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, 2003

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Government Document Conference Proceeding Book
12
Guidance for industry : Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products.
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, 1999

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Government Document Conference Proceeding Book
13
Guidance for industry : E2E pharmacovigilance planning.
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

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Government Document Conference Proceeding Book
14
Guidance for industry : E2BM data elements for transmission of individual case safety reports.
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, 2002

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Government Document Conference Proceeding Book
15
Guidance for industry.
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, 2008
Revision 2

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Government Document Conference Proceeding Book
16
Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
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

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Government Document Conference Proceeding Book
17
Guidance for industry.
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, 2001

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Government Document Conference Proceeding Book
18
Guidance for industry : S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals.
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, 1997

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Government Document Conference Proceeding Book
19
Guidance for industry : Q1B photostability testing of new drug substances and products.
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, 1996

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Government Document Conference Proceeding Book
20
Guidance for industry : Q3C impurities, residual solvents.
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, 1997

This item is not available through EZBorrow. Please contact your institution’s interlibrary loan office for further assistance.
Government Document Conference Proceeding Book
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