Categories
Technical
Study
Novel
Nonfiction
Health
-- Health
-- Medical
Tutorial
Entertainment
Business
Magazine
Arts & Design
Audiobooks & Video Training
Cultures & Languages
Family & Home
Law & Politics
Lyrics & Music
Software Related
eBook Torrents
Uncategorized
Study
Novel
Nonfiction
Health
-- Health
-- Medical
Tutorial
Entertainment
Business
Magazine
Arts & Design
Audiobooks & Video Training
Cultures & Languages
Family & Home
Law & Politics
Lyrics & Music
Software Related
eBook Torrents
Uncategorized
Share With Friends
Archive by Date
2012-08-06
2012-08-05
2012-08-04
2012-08-03
2012-08-02
2012-08-01
2012-07-31
2012-07-30
2012-07-29
2012-07-28
2012-08-05
2012-08-04
2012-08-03
2012-08-02
2012-08-01
2012-07-31
2012-07-30
2012-07-29
2012-07-28
Search Tag
McGuffey
Dementer
MaxiMoto
PUATraining
在人间
Inconcluso
Dunne
发财梦
Clitic
APPLIED
Accordion
1085
Cejrowski
Amboy
1067
vaterland
Syncrometer
Vraies
Witcobber
Cryogenics
Silan
Amulett
Brummer
boating
GOLF
Knoll
Blutiges
Caffey
Markovik
Golijov
SUPPORTS
图式符号
Mytoolsoft
Gufeld
ESPA
Morena
阿利埃尔
Buetow
Gebaude
bilim
Motwani
TEACHING
Chaney
Macgyver
Gomedia
Scholasticism
FebruaryMarch
Unhinged
religi
Oaks
Newest
Infrared Spectroscopy - Life and Biomedical Sciences
Medical Physiology - Principles for Clinical Medicine (4th edition)
Medical Physiology: Principles for Clinical Medicine (4th edition) [Repost]
Hypnosis: Medical, Scientific or Occultic? (repost)
Handbook of Antimicrobial Therapy by Medical Letter, Mark Abramowicz, M.D. and Gianna Zuccotti
Medical Management of the Thoracic Surgery Patient Expert Consult - Online and Print, 1e (Repost)
Achieving Excellence in Medical Education (2nd edition) [Repost]
Medical Dosage Calculations: A Dimensional Analysis Approach, 10th Edition (Repost)
A Guide to Methods in the Biomedical Sciences [Repost]
Medical Cirugia de Michans / Michan's Surgery (Spanish Edition)
Sherris Medical Microbiology, 5th Edition
Your Medical Mind: How to Decide What Is Right for You (Repost)
For Dummies Series PDF - [ Medical ]
Medical e-Books Megapack English
Mechanical Circulatory Support (Landes Bioscience Medical Handbook (Vademecum)) by Wayne E. Richenbacher (Repost)
Analyzing the Large Number of Variables in Biomedical and Satellite Imagery (Repost)
How to Study in Medical School
Biomedical Simulation (repost)
Polyphosphazenes for Biomedical Applications by A. K. Andrianov (Repost)
Costanza Medical Physiology Video Lectures
Medical Physiology - Principles for Clinical Medicine (4th edition)
Medical Physiology: Principles for Clinical Medicine (4th edition) [Repost]
Hypnosis: Medical, Scientific or Occultic? (repost)
Handbook of Antimicrobial Therapy by Medical Letter, Mark Abramowicz, M.D. and Gianna Zuccotti
Medical Management of the Thoracic Surgery Patient Expert Consult - Online and Print, 1e (Repost)
Achieving Excellence in Medical Education (2nd edition) [Repost]
Medical Dosage Calculations: A Dimensional Analysis Approach, 10th Edition (Repost)
A Guide to Methods in the Biomedical Sciences [Repost]
Medical Cirugia de Michans / Michan's Surgery (Spanish Edition)
Sherris Medical Microbiology, 5th Edition
Your Medical Mind: How to Decide What Is Right for You (Repost)
For Dummies Series PDF - [ Medical ]
Medical e-Books Megapack English
Mechanical Circulatory Support (Landes Bioscience Medical Handbook (Vademecum)) by Wayne E. Richenbacher (Repost)
Analyzing the Large Number of Variables in Biomedical and Satellite Imagery (Repost)
How to Study in Medical School
Biomedical Simulation (repost)
Polyphosphazenes for Biomedical Applications by A. K. Andrianov (Repost)
Costanza Medical Physiology Video Lectures
Useful Links
Medical Statistics In Drug Research: Methodologies and Recent Developments (Biostatistics, 10)
Posted on 2010-03-15
|
Statistics In Drug Research: Methodologies and Recent Developments (Biostatistics, 10) By Shein-Chung Chow Publisher: CRC
Number Of Pages: 367 Publication Date: 2002 Sales Rank: 1460072 ISBN / ASIN: 082470763X EAN: 9780824707637 Binding: Hardcover Manufacturer: CRC Studio: CRC Average Rating: 5 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 performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials. Review: belongs on desk of every pharmaceutical biostatistician This is a very new and unique book that covers the gamut of statistical issues through all phases of drug development. Shao is a distinguished professor from Wisconsin and Chow teaches at Temple but is known for his long career in the pharmaceutical industry. The book is good for biostatisticians and regulatory affairs specialists as a reference source. All the key statistical issues are addressed and the reader is given the perspective of the ICH and FDA guidance documents. The underlying statistical methodology that justifies the recommendations in the guidances is presented. This is a state-of-the-art book. Shao and Pigeot produced some of the recent research in individual bioequivalence that established a bootstrap procedure as an appropriate way to construct confidence intervals for the problem. Their method is recommended in an FDA guidance document. But more than just this one example, all the key issues that have been the subject of FDA workshops over the past several years are addressed in this book. These topics include calibration, assay and assay validation, dissolution testing, stability analysis, shelf life estimation, bioequivalence, randomization and blinding, what constitutes substantive evidence in clinical development, therapeutic equivalence and noninferiority, Bayesian approaches in clinical trials, problems involving missing and incomplete data, longitudinal methods, meta-analysis, quality of life studies and instrument validation, and medical imaging. Other prevalent issues in clinical trials include group sequential methods, hierarchical Bayesian models and multiple testing. These issues are not covered as much in this text as the others we have mentioned. But there is some discussion of multiplicity in the context of quality of life studies. An example of sequential testing is used to illustrate model selection in Chapter 2. The important issues of design and sample size requirements are presented throughout the book. While not all topics are covered in sufficient depth, the book is remarkable in the breadth of material covered in just 350 pages of text. The authors also provide a very authoritative list of references and regulatory guidances and other documents.pass: gigapedia.org
Rating:
2.5 out of 5 by Book123 |
Download Links | |
Server | Status |
---|---|
Direct Download Link 1 | Alive |
Direct Download Link 2 | Alive |
Download Link (Download Link 1) | Alive |
Download Link (Download Link 1) | Alive |
Buy This Book at Best Price >> |
Like this article?! Give us +1: