Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability

CRC Press
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"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
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About the author

Chow, Shein-Chung; Liu, Jen-pei
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Additional Information

Publisher
CRC Press
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Published on
Oct 3, 2018
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Pages
580
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ISBN
9781482273137
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Best For
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Language
English
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Genres
Mathematics / Probability & Statistics / General
Medical / Pharmacology
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Content Protection
This content is DRM protected.
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Eligible for Family Library

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Praise for the Second Edition:

"... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study."

-Biometrics

"This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society

Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation.

Features:

Compares the relative merits and disadvantages of statistical methods for sample size calculations

Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages

Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health

Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches

This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

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