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BOOK EXCERPT:
"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters."
Product Details :
Genre |
: Mathematics |
Author |
: Shein-Chung Chow |
Publisher |
: CRC Press |
Release |
: 1999-11-24 |
File |
: 606 Pages |
ISBN-13 |
: 1420002023 |
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BOOK EXCERPT:
Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva
Product Details :
Genre |
: Mathematics |
Author |
: Shein-Chung Chow |
Publisher |
: CRC Press |
Release |
: 2008-10-15 |
File |
: 758 Pages |
ISBN-13 |
: 9781420011678 |
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BOOK EXCERPT:
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 discrepancies and how to avoid them. This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions. The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.
Product Details :
Genre |
: Mathematics |
Author |
: Shein-Chung Chow |
Publisher |
: CRC Press |
Release |
: 2003-03-04 |
File |
: 352 Pages |
ISBN-13 |
: 9780824748234 |
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BOOK EXCERPT:
Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or "noninformativeness" of the censoring mechanisms relative to the event. Design and Analysis of Clinical Trials with Time-to-Event Endpoints provides a thorough presentation o
Product Details :
Genre |
: Mathematics |
Author |
: Karl E. Peace |
Publisher |
: CRC Press |
Release |
: 2009-04-23 |
File |
: 618 Pages |
ISBN-13 |
: 9781420066401 |
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BOOK EXCERPT:
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta
Product Details :
Genre |
: Mathematics |
Author |
: Shein-Chung Chow |
Publisher |
: CRC Press |
Release |
: 2007-05-30 |
File |
: 351 Pages |
ISBN-13 |
: 9781584889069 |
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BOOK EXCERPT:
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the w
Product Details :
Genre |
: Mathematics |
Author |
: Jen-pei Liu |
Publisher |
: CRC Press |
Release |
: 2012-07-26 |
File |
: 285 Pages |
ISBN-13 |
: 9781439846353 |
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BOOK EXCERPT:
The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Using examples from real clinical trials, Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority tr
Product Details :
Genre |
: Mathematics |
Author |
: Mark D. Rothmann |
Publisher |
: CRC Press |
Release |
: 2016-04-19 |
File |
: 451 Pages |
ISBN-13 |
: 9781584888055 |
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BOOK EXCERPT:
Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fu
Product Details :
Genre |
: Mathematics |
Author |
: Weichung Joe Shih |
Publisher |
: CRC Press |
Release |
: 2015-07-28 |
File |
: 240 Pages |
ISBN-13 |
: 9781482250503 |
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BOOK EXCERPT:
Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers in various healthcare systems. Although many books exist that address the theoretical or practical aspects of cost-effectiveness analysis, this book differentiates itself from the competition by detailing
Product Details :
Genre |
: Mathematics |
Author |
: Iftekhar Khan |
Publisher |
: CRC Press |
Release |
: 2015-11-11 |
File |
: 332 Pages |
ISBN-13 |
: 9781466505483 |
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BOOK EXCERPT:
Analyze Repeated Measures Studies Using Bayesian TechniquesGoing beyond standard non-Bayesian books, Bayesian Methods for Repeated Measures presents the main ideas for the analysis of repeated measures and associated designs from a Bayesian viewpoint. It describes many inferential methods for analyzing repeated measures in various scientific areas,
Product Details :
Genre |
: Mathematics |
Author |
: Lyle D. Broemeling |
Publisher |
: CRC Press |
Release |
: 2015-08-04 |
File |
: 568 Pages |
ISBN-13 |
: 9781482248203 |