Encyclopedia of Biopharmaceutical Statistics, Second Edition / Edition 2

by Shein-Chung Chow, Chow Chow

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

Editorial Reviews

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. Annotation c. Book News, Inc., Portland, OR (booknews.com)

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