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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
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter.

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Government Document Conference Proceeding Book
3
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
4
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Dissolution Test General Chapter.

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Government Document Conference Proceeding Book
5
Proceedings of the Sixth International Symposium on Pertussis :
Bethesda, Md. : Department of Health and Human Services, United States Public Health Service, Food and Drug Administration, 1990

Government Document Conference Proceeding Book
6
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
7
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

This item is not available through EZBorrow. Please contact your institution’s interlibrary loan office for further assistance.
Government Document Conference Proceeding Book
8
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
9
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
10
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

This item is not available through EZBorrow. Please contact your institution’s interlibrary loan office for further assistance.
Government Document Conference Proceeding Book
11
Proceedings of the Sixth International Symposium on Pertussis
Bethesda, Md. : Dept. of Health and Human Services, U.S. Public Health Service, Food and Drug Administration, 1990

This item is not available through EZBorrow. Please contact your institution’s interlibrary loan office for further assistance.
Government Document Conference Proceeding Book
12
Proceedings of the Sixth International Symposium on Pertussis, Jack Masur Auditorium, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland, September 26-28, 1990 /
Bethesda, Md. : [Springfield, Va. : Dept. of Health and Human Services, U.S. Public Health Service, Food and Drug Administration ; Available from the National Technical Information Service], 1991

Government Document Conference Proceeding Book
13
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
14
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
15
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
16
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
17
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
18
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Dosage Units, General Chapter.
[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research], 2008

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Government Document Conference Proceeding Book
19
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
20
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

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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