Design and Analysis of Clinical Trials(2nd Edition) Concepts and Methodologies (Wiley Series in Probability and Statistics) by Shein-ChungChow, Jen-Pei Liu Hardcover, 752 Pages, Published 2003 by Wiley-Interscience ISBN-13: 978-0-471-24985-6, ISBN: 0-471-24985-8
"Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." -Statistical Methods in Medicine A complete and balanced presentation now revised, updated ..."
"Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of d ..."
"Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of d ..."
"Methodologies and Recent Developments Shein-Chung Chow, Jun Shao. Note
that Chow, Shao, and Wang's test is different from the one recommended in FDA
(2001) (see §5.3.3). Theoretically, the asymptotic size of Chow, Shao, and
Wang's test is exactly the same as the nominal level 5%, whereas the asymptotic
size of FDA's test is smaller than 5% (see §5.3.3) and is inappropriate. Chow,
Shao, and Wang (2001b) studied and compared empirica ..."
"Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of d ..."
"Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of d ..."
"Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of d ..."
"Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of d ..."
"Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of d ..."
"On the other side, in (4.2.5) the same quantity is estimated by MLE under the null
hypothesis (p1=p2), which gives . We will refer to (4.2.1) ... However, a drawback
of the conditional approach is that it is difficult to be generalized to other testing
problems, e.g., superiority, non-inferiority/equivalence. Let When ... As a result, in
this section and also the following section, we will focus on the unconditional
method because ..."
"Methodologies and Recent Developments Shein-Chung Chow, Jun Shao.
whereas the estimator of Öh based on data from study h only is given by (5.3.2),
i.e., - 6, = "lik + J22h - J12h - #21h =— Chow and Shao (1999) showed that 5, is
not always better than 6. In fact, Var(5) – Var(5)=(c. – Ch)(giF-2phaeria BR),
where CH = (XX-1 c.')" < ch. That is, combining data sets leads to a more efficient
estimator of Óh if and only if the total var ..."
Statistics in Drug Research(1st Edition) Methodologies and Recent Developments (Chapman & Hall/CRC Biostatistics Series) by Shein-ChungChow, Jun. Chow Shao Hardcover, 384 Pages, Published 2002 by Crc Press International Edition ISBN-13: 978-0-8247-0763-7, ISBN: 0-8247-0763-X
"Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performanc ..."
""Tissue Engineering and Biodegradable Equivalents: Scientific and Clinical Applications" surveys a wide range of natural and synthetic compounds used in tissue, bone, muscle, cartilage, and organ replacement and discusses recent methods for processing, characterizing, and testing these biomaterials. The book offers effective techniques to manipulate cells and growth factors successfully in the construction, restoration, and regeneration ..."
"Intended to help scientists understand the statistical language in pharmaceutical development, this reference presents designs and analyses utilized at different stages of pharmaceutical development, current regulatory requirements, and ..."
"Reporting from the cutting-edge of this rapidly evolving field, this unequaled resource has expanded to review amendments to regulatory requirements and recently developed statistical methods impacting the drug review/approval process and biopharmaceutical research and development. It alerts specialists to current standards and best practices in clinical, laboratory, manufacturing, and statistical design, investigation, and analysis. Th ..."