-
2
-
-
84856378855
-
Calculation assumes alpha = 0.05, power=0.8, drug proportion = 10 in 10,000, placebo proportion =1 in 10,000 equally sized groups, continuity correction to approximate binomial distribution
-
See, See also, by Joseph L. Fleiss, 2nd ed., 1981, John Wiley & Sons, NY), chapter 3
-
See www.statpages.org. Calculation assumes alpha = 0.05, power=0.8, drug proportion = 10 in 10,000, placebo proportion =1 in 10,000 equally sized groups, continuity correction to approximate binomial distribution. See also Statistical Methods for Rates and Proportions by Joseph L. Fleiss, 2nd ed., 1981, John Wiley & Sons, NY), chapter 3.
-
Statistical Methods for Rates and Proportions
-
-
-
4
-
-
79551652141
-
-
Note
-
Final rule: requirements on content and format of labeling for human prescription drug and biological products.
-
-
-
-
5
-
-
79551639453
-
-
Note
-
Guidance for industry, adverse events section of labeling for human prescription drug and biological products-content and format. US Dept HHS, FDA, CDER, CBER, Jan 2006.
-
-
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7
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-
79551617347
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Note
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Guidance for industry, revising ANDA labeling following revision of the RLD labeling, US Dept HHS, FDA, CDER, May 2006.
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8
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0036195685
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10
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84856377630
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Note
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World Health Organization adverse reaction terminology (WHO-ART) system is maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization collaborating centre for international drug monitoring; coding symbols for thesaurus of adverse reaction terms (COSTART) was developed by FDA and is being replaced by MedDRA. The medical dictionary for regulatory activities (MedDRA) is the international medical terminology developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), see www.meddramsso.com
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12544251868
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Mechanistic basis of adverse drug reactions: The perils of inappropriate dose schedules
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53249086098
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Women encounter ADRs more often than do men
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84856398146
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Calculation assumes alpha = 0.05, power=0.8, drug proportion = 5%, placebo proportion = 1%, equally sized groups, continuity correction to approximate binomial distribution. See also Statistical Methods for Rates and Proportions by Joseph L. Fleiss, 2nd ed, John Wiley & Sons, NY), chapter 3
-
See www.statpages.org. Calculation assumes alpha = 0.05, power=0.8, drug proportion = 5%, placebo proportion = 1%, equally sized groups, continuity correction to approximate binomial distribution. See also Statistical Methods for Rates and Proportions by Joseph L. Fleiss, 2nd ed., 1981, John Wiley & Sons, NY), chapter 3.
-
(1981)
-
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-
21
-
-
84856398147
-
-
Calculation assumes alpha = 0.05, power=0.8, drug proportion = 5%, placebo proportion = 1%, equally sized groups, continuity correction to approximate binomial distribution. See also Statistical Methods for Rates and Proportions by Joseph L. Fleiss, 2nd ed, John Wiley & Sons, NY), chapter 3
-
nd ed., 1981, John Wiley & Sons, NY), chapter 3.
-
(1981)
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22
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33644906137
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Brief communication: Better ways to question patients about adverse medical events: A randomized, controlled trial
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8744229000
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Better reporting of Harms in Randomized Trials: An extension of the CONSORT statement
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