Abstract:
:A statistic, W, for measuring change from baseline is developed. Its distribution is found. Simulations using W and analysis of covariance (ANCOVA) are run and the results are compared. W is found to be less powerful than ANCOVA, yet is not seen to suffer some of the ill effects to which ANCOVA can fall prey, namely bias introduced by chance covariate imbalance.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Donahue RMdoi
10.1080/10543409708835187subject
Has Abstractpub_date
1997-05-01 00:00:00pages
287-99issue
2eissn
1054-3406issn
1520-5711journal_volume
7pub_type
杂志文章abstract::Sample size calculation based on normal approximations is often associated with the loss of statistical power for a single-arm trial with a time-to-event endpoint. Recently, Wu (2015) derived the exact variance for the one-sample log-rank test under the alternative and showed that a single-arm one-stage study based on...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2020.1730869
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2011.616972
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abstract::Frequentist design for two-arm randomized Phase II clinical trials with outcomes from the exponential dispersion family was proposed previously, where the total sample sizes are minimized under multiple constraints on the standard errors of the estimated group means and their difference. This design was generalized fr...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2017.1402779
更新日期:2018-01-01 00:00:00
abstract::The concept of quality by design (QbD) as published in ICH-Q8 is currently one of the most recurrent topics in the pharmaceutical literature. This guideline recommends the use of information and prior knowledge gathered during pharmaceutical development studies to provide a scientific rationale for the manufacturing p...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2014.979197
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abstract::Bowker's test, a generalization of McNemar's test, performs well under the hypothesis of symmetry, but the estimator of variance used in the test is biased when the table is asymmetric and this calls into question the test's performance in non-null situations. We seek an alternative to Bowker's test in search of metho...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2017.1293081
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 临床试验,杂志文章
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更新日期:1994-07-01 00:00:00
abstract::An attractive application of expression technologies is to predict drug efficacy or safety using expression data of biomarkers. To evaluate the performance of various classification methods for building predictive models, we applied these methods on six expression datasets. These datasets were from studies using micro...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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abstract::In clinical trials of drug development, patients are often followed for a certain period of time, and the outcome variables are measured at scheduled time intervals. The main interest of the trial is the treatment efficacy at a prespecified time point, which is often the last visit. In such trials, patient dropout is ...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543400903242753
更新日期:2009-11-01 00:00:00
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543400701329497
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2014.919936
更新日期:2015-01-01 00:00:00
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2013.834914
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2020.1832110
更新日期:2020-11-11 00:00:00
abstract::In recent years, development of biosimilar products has attracted considerable attention. Because of the structural complexity of biologics, it is difficult to demonstrate that a biosimilar product is identical to the reference product. Therefore, for the development of biosimilar products, we need to adopt an approac...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2014.941983
更新日期:2014-01-01 00:00:00
abstract::Pressures for rapid drug development, especially for treatments that may affect public health significantly, drive a need to reconsider what is necessary to establish the "substantial evidence" of efficacy and safety required for regulatory approval. The concept of substantial evidence of effect can be stated fairly s...
journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1081/bip-120005740
更新日期:2002-02-01 00:00:00
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2013.813519
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
doi:10.1080/10543406.2013.813516
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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journal_title:Journal of biopharmaceutical statistics
pub_type: 杂志文章
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