Zobrazeno 1 - 10 of 25 pro vyhledávání: '"Karl K. Lin"'
1
Statistics in Pharmacology and Toxicology
Autor: Karl K. Lin, Mohammad Atiar Rahman
Publikováno v: Drug Discovery and Development ISBN: 9789811555336
In this chapter, we gave an introduction to basic statistics. The topics include definitions of statistical terminologies, sampling distributions, data presentation, and descriptive statistics, designs of an experiment, statistical inference, and reg
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::7f654007407cfbbfa7abe177ba529886
https://doi.org/10.1007/978-981-15-5534-3_18
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2
Comparisons of false negative rates from a trend test alone and from a trend test jointly with a control-high groups pairwise test in the determination of the carcinogenicity of new drugs
Autor: Mohammad Atiar Rahman, Karl K. Lin
Publikováno v: Journal of Biopharmaceutical Statistics. 29:128-142
Interest has been expressed in using a joint test procedure that requires that the results of both a trend test and a pairwise comparison test between the control and the high groups be statistically significant simultaneously at the levels of signif
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bfb457124f0bab48455e886b28fcca82
https://doi.org/10.1080/10543406.2018.1473874
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3
Exact Poly-KTest
Autor: Karl K. Lin, Ram C. Tiwari, Matthew Jackson, Mohammad A. Rahman
Publikováno v: Communications in Statistics - Simulation and Computation. 45:2257-2266
For animal carcinogenicity study with multiple dose groups, positive trend test and pairwise comparisons of treated groups with control are generally performed using the Cochran-Armitage, Peto test, or Poly-K test. These tests are asymptotically norm
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::681fc54c7d94fdd77e1b8f5c7c73bc1c
https://doi.org/10.1080/03610918.2014.901351
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4
Regulatory Nonclinical Statistics
Autor: Xiaoyu Dong, Meiyu Shen, Mohammad Atiar Rahman, Yi Tsong, Karl K. Lin
Publikováno v: Nonclinical Statistics for Pharmaceutical and Biotechnology Industries ISBN: 9783319235578
The nonclinical statistics teams in the Center of Drug Review and Research of the Food and Drug Administration (FDA) conduct regulatory reviews, statistical consultation, and statistical methodology development in nonclinical regulations. In this cha
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::3fb841a3acf0d730cb370e9662de6861
https://doi.org/10.1007/978-3-319-23558-5_2
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5
Recent Research Projects by the FDA’s Pharmacology and Toxicology Statistics Team
Autor: Matthew T. Jackson, Steven F. Thomson, Karl K. Lin, Min Min, Mohammad Atiar Rahman
Publikováno v: Nonclinical Statistics for Pharmaceutical and Biotechnology Industries ISBN: 9783319235578
In addition to regular review work, the Pharmacology and Toxicology Statistics Team in CDER/FDA is actively engaged in a number of research projects. In this chapter we summarize some of our recent investigations and findings.
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https://doi.org/10.1007/978-3-319-23558-5_12
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7
Evaluation of the Tg.AC Assay: Specificity Testing with Three Noncarcinogenic Pharmaceuticals that Induce Selected Stress Gene Promoters in Vitro and the Inhibitory Effects of Solvent Components
Autor: Jun Zhang, Karl K. Lin, Frank D. Sistare, Barry A. Rosenzweig, James L. Weaver, Karol L. Thompson
Publikováno v: Toxicological Sciences. 74:271-278
Understanding the strengths and limitations of alternative models, such as the Tg.AC assay, for evaluation of the potential carcinogenicity of pharmaceuticals requires assessment of assay specificity through studies that specifically target biologica
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::591f3398fa09999d4efaac3f0edca4a4
https://doi.org/10.1093/toxsci/kfg141
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8
PROGRESS REPORT ON THE GUIDANCE FOR INDUSTRY FOR STATISTICAL ASPECTS OF THE DESIGN, ANALYSIS, AND INTERPRETATION OF CHRONIC RODENT CARCINOGENICITY STUDIES OF PHARMACEUTICALS
Autor: Karl K. Lin
Publikováno v: Journal of Biopharmaceutical Statistics. 10:481-501
The U.S. Food and Drug Administration (FDA) is in the process of preparing a draft Guidance for Industry document on the statistical aspects of carcinogenicity studies of pharmaceuticals for public comment. The purpose of the document is to provide s
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a77b3146c6ee8fee8d9fa82d679c9588
https://doi.org/10.1081/bip-100101980
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10
CDER/FDA Formats for Submission of Animal Carcinogenicity Study Data
Autor: Karl K. Lin
Publikováno v: Drug Information Journal. 32:43-52
The Center for Drug Evaluation and Research/Food and Drug Administration (CDER/FDA) routinely requests that drug sponsors submit in their New Drug Applications' carcinogenicity studies electronic d...
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::3f28c6b51a28e00382c2552e83253025
https://doi.org/10.1177/009286159803200107
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