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International Conference on Harmonisation.
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1
Structure and content of clinical study reports
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], 1996
Description: 1 online resource (various pagings) : forms, charts.
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2
Studies in support of special populations, geriatrics
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Center for Drug Evaluation], 1994
Description: 1 online resource (6 pages).
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3
Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], 2007
Description: 4 unnumbered pages : digital, PDF file.
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4
Q4B, annex 3, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particles
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], 2007
Description: 7 unnumbered pages : digital, PDF file.
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5
Guidance for industry granularity document : annex to M4, organization of the CTD
Published: 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: 10 pages : digital, PDF file.
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6
Guidance for industry M4Q, the CTD, quality
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2001
Description: 29 pages : digital, PDF file.
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7
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Dosage Units, General Chapter
Published: [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research], 2008
Description: 3 pages : digital, PDF file.
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8
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter
Description: 10 pages : digital, PDF file.
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9
S9 nonclinical evaluation for anticancer pharmaceuticals
Published: [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research], 2009
Description: 10 unnumbered pages : digital, PDF file.
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10
Post-approval safety data management definitions and standards for expedited reporting
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 2003
Description: 12 : digital, PDF file.
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11
Principles for clinical evaluation of new antihypertensive drugs
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 2000
Description: i, 8 pages : digital, PDF file.
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12
S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2008
Description: 1 online resource (37 pages)
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13
Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Dissolution Test General Chapter
Description: 4 unnumbered pages, 3 pages : digital, PDF file.
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14
Quality of biotechnological products analysis of the expression construct in cells used for production of r-DNA derived protein products
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], 1996
Description: 1 online resource ( i, 4, 1 page).
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15
Dose-response information to support drug registration
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], 1994
Description: 1 online resource (15 pages).
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16
Addendum to ICH S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration], 2009
Description: 1 online resource (iv, 14 pages)
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17
Guidance for industry E 10 choice of control group and related issues in clinical trials
Published: 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
Description: 1 online resource (ii, 33 pages) : chart.
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18
Guidance for industry Q1B photostability testing of new drug substances and products
Published: 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
Description: 1 online resource (i, 11 pages)
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19
Guidance for industry Q1C stability testing for new dosage forms
Published: 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
Description: 1 online resource (1 pages)
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20
Guidance for industry Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 1998
Description: 1 online resource (i, 30 pages)
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