Encyclopedia of Biopharmaceutical Statistics, Second Edition / Edition 2

Encyclopedia of Biopharmaceutical Statistics, Second Edition / Edition 2

by Shein-Chung Chow, Chow Chow
     
 

ISBN-10: 0824742613

ISBN-13: 9780824742614

Pub. Date: 06/04/2003

Publisher: Taylor & Francis

The only encyclopedia that specifically focuses on biopharmaceutical statistics, the 3rd Edition provides a well-balanced summary of current regulatory requirements, along with a comprehensive and unified presentation of designs and analyses used at different stages of biopharmaceutical and clinical research and development. This is the definitive statistical guide

Overview

The only encyclopedia that specifically focuses on biopharmaceutical statistics, the 3rd Edition provides a well-balanced summary of current regulatory requirements, along with a comprehensive and unified presentation of designs and analyses used at different stages of biopharmaceutical and clinical research and development. This is the definitive statistical guide for the entire pipeline of drug/pharmaceutical product development: from non-clinical and pre-clinical assessments and manufacturing processes through to clinical trials, regulatory processes and postmarketing surveillence.

Thoroughly exploring emerging technologies, concepts, and trends, this edition incorporates 89 brand new chapters on subjects such as biomarker development, target clinical trials and follow-on biologics. Previous contents of this title have been revised and updated, and cover topics ranging from in vitro bioequivalence testing and dissolution profile comparison to bridging studies, MedDRA, vaccine clinical trials and medical devices. The encyclopedia also includes popular topics that are currently under discussion within regulatory agencies and the pharmaceutical/biotech industry, such as pharmacoeconomics, reproducibility and probability in clinical research.

Available in hard copy and online formats, this highly specialised book is a must-have resource for pharmaceutical R&D departments as well as for statisticians and researchers who work on clinical trials regulated by the FDA.

Product Details

ISBN-13:
9780824742614
Publisher:
Taylor & Francis
Publication date:
06/04/2003
Edition description:
2nd Edition, Revised & Expanded
Pages:
1000
Product dimensions:
8.60(w) x 11.10(h) x 2.40(d)

Table of Contents

Adjustment for Covariates-- Thomas Permutt
Ames Test-- Wherly P. Hoffman and Michael L. Garriott
Assay Development-- Timothy L. Schofield
Assay Validation-- Timothy L. Schofield
Bayesian Statistics-- Julia A. Varshavsky and Stacy R. David
Bioassay-- Anant M. Kshirsagar
Bioavailability and Bioequivalence-- Brian P. Smith
Biologics-- Peter A. Lachenbruch, A. Dale Horne, Cornelius J. Lynch,
Jawahar-- Tiwari, and Susan S. Ellenberg
Biopharmaceutics-- Iain J. McGilveray
Bracketing Design-- John R. Murphy
Cancer Trials-- Clet Niyikiza and Douglas E. Faries
Carcinogenicity Studies of Pharmaceuticals-- Karl K. Lin
Carry-Forward Analysis-- Naitee Ting
Clinical Endpoint-- Sofia Paul
Clinical Pharmacology-- Brian P. Smith
Clinical Trials-- Kenneth B. Schechtman
Clinical Trial Process-- Paul F. Kramer
Confounding and Interaction-- Catharine B. Stack
Content Uniformity-- John R. Murphy
Contract Research Organization (CRO)-- T. Y. Lee
Crossover Design-- Stephen Senn
Cutoff Designs-- Joseph C. Cappelleri and William M. K. Trochim
Data Monitoring Board (DMB)-- Walter W.Offen
Dose Proportionality-- C. Gordon Law
Dropout-- Cindy Rodenberg and Shu-lin Cheng
Drug Development-- Naitee Ting
Enrichment Design-- Jen-pei Liu
Equivalence Trials-- Jen-pei Liu
Ethnic Factors-- Melody H. Lin and Helen McGough
Extra Variation Models-- Jorge G. Morel and Nagaraj K. Neerchal
Factorial Designs-- Junfang Li
Food and Drug Administration-- Stacy R. David and Susan S. Ellenberg
Global Database and System-- Alice T. M. Hsuan and Patrick Genyn
Good Programming Practice-- Aileen L. Yam
Good Statistics Practice-- Shein-Chung Chow
Group Sequential Methods-- Weichung Joe Shih
Individual Bioequivalence-- Shein-Chung Chow and Jen-pei Liu
Integrated Summary Report-- Laura J. Meyerson
Intention-to-Treat Analyses-- Ronald K. Knickerbocker
International Conference on Harmonization (ICH)-- Jen-pei Liu and Shein-Chung Chow
IVRS-- Mon-Gy Chen
Lilly Reference Ranges-- Michael G. Wilson
Meta-Analysis of Therapeutic Trials-- Joseph C. Cappelleri, John P. A. Ioannidis, and Joseph Lau
Mixed Effects Models-- Donghui Zhang and A. Lawrence Gould
Multicenter Trials-- William J. Huster
Multiple Comparisons-- Mani Y. Lakshminarayanan
Multiple-Dose Bioequivalence Studies-- Vernon M. Chinchilli and William H. Barr
Multiple Endpoints-- Mario Comelli
Parallel Design-- Mani Y. Lakshminarayanan
Patient Compliance-- Kenneth B. Schechtman
Pharmacodynamic Issues-- Cheng-Tao Chang and Robert Wong
Pharmacodynamics with Covariates-- Cheng-Tao Chang and Robert Wong
Pharmacodynamics with No Covariates-- Cheng-Tao Chang and Robert Wong
Pharmacoeconomics-- Joseph F. Heyse, John R.Cook, and Michael F. Drummond
Placebo Effect-- Thomas R. Stiger and Edward F. C. Pun
Postmarketing Surveillance-- Patricia B. Cerrito
Power-- Kenneth B. Schechtman
Protocol Development-- Robert D. Chew
Process Validation-- James Bergum and Merlin L. Utter
Release Targets-- Greg C. G. Wei
Reproductive Studies-- James J. Chen
Robust Analysis for Crossover Design-- M. Mushfiqur Rashid
Sample Size Determination-- Lilly Q. Yue, David Li, and Shan Bai
Screening Design-- John R. Murphy
Specifications-- John R. Murphy
Stability Matrix Designs-- Earl Nordbrock
Statistical Significance-- Dieter Hauschke, Robert Schall, and Herman G. Luus
Subgroup Analysis-- Patricia B. Cerrito
Surrogate Endpoint-- Shu Zhang and Edward F. C. Pun
Therapeutic Equivalence-- Jen-pei Liu
Titration Design-- Marilyn A. Agin and Edward F. C. Pun
USP Tests-- John R. Murphy

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