Release Date: 01 January, 2000
Hardcover
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From Book News, Inc.
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 recently developed statistical methods. The 72 alphabetically arranged entries include explanations of the Ames test, assay validation, carcinogenicity studies of pharmaceuticals, carry-forward analysis, data monitoring boards, dropout, ethnic factors, factorial designs, group sequential methods, multiple endpoints, pharmacoeconomics, sample size determination, stability matrix designs, subgroup analysis, and titration design.Book News, Inc.®, Portland, OR
Book Description
Remaining on the cutting-edge of this rapidly evolving field, this unequaled resource has expanded more than 70% of its original entries to review ammendments to regulatory requirements and recently developed statistical methods impacting the drug review/approval process and biopharmaceutical research and development. Alerts specialists to current standards and best practices in clinical, laboratory, manufacturing, and statistical design, investigation, and analysis.--This text refers to the Hardcover edition.
Book Info
User-friendly reference covers all key topics for evaluation of data at critical stages in the pharmaceutical research and development process-highlighting the vital areas of statistical design and regulatory requirements. Rating 5.0
provides articles on statistical terms used in drug studiesChow has done an excellent job of collecting articles from the leading researchers in the pharmaceutical and biologics industry including FDA employees. The terms are specialized but important to those industries. The articles are scholarly and informative. The quality is similar to those in the Encyclopedia of Statistical Science. Most of the terms are also of interest to statisticians like myself who work in the medical device industry. A sample of the items are "Adjustment for Covariates", "Bayesian Statistics", "Boassay", "Clinical Trials", "Equivalence Trials", "Food and Drug Administration", "Intention-to-Treat Analyses", "International Conference on Harmonization", "Multiple Comparisons", "Postmarketing Surveillance", "Sample Size Determination", and "Surrogate Endpoint".This is a particularly good reference for statisticians who work on clinical trials regulated by the FDA. However keep in mind that it is very specialized and is rather expensive. |
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