Encyclopedia of Biopharmaceutical Statistics

by Chow, Shein-Chung

• ISBN13: 9780824760014
• ISBN10: 0824760018
• Format: Hardcover
• Copyright: 2000-01-01
• Publisher: CRC Pr I Llc

Summary

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.

Table of Contents

Preface	iii
Contributors	xi
Adjustment for Covariates	1	(3)
Thomas Permutt
Ames Test	4	(9)
Wherly P. Hoffman
Michael L. Garriott
Assay Development	13	(8)
Timothy L. Schofield
Assay Validation	21	(10)
Timothy L. Schofield
Bayesian Statistics	31	(8)
Julia A. Varshavsky
Stacy R. David
Bioassay	39	(3)
Anant M. Kshirsagar
Bioavailability and Bioequivalence	42	(5)
Brian P. Smith
Biologics	47	(7)
Peter A. Lachenbruch
A. Dale Horne
Cornelius J. Lynch
Jawahar Tiwari
Susan S. Ellenherg
Biopharmaceutics	54	(23)
Iain J. McGilveray
Bracketing Design	77	(2)
John R. Murphy
Cancer Trials	79	(9)
Clet Niyikiza
Douglas E. Faries
Carcinogenicity Studies of Pharmaceuticals	88	(15)
Karl K. Lin
Carry-Forward Analysis	103	(7)
Naitee Ting
Clinical Endpoint	110	(4)
Sofia Paul
Clinical Pharmacology	114	(3)
Brian P. Smith
Clinical Trials	117	(8)
Kenneth B. Schechtman
Clinical Trial Process	125	(3)
Paul F. Kramer
Confounding and Interaction	128	(6)
Catharine B. Stack
Content Uniformity	134	(3)
John R. Murphy
Contract Research Organization (CRO)	137	(5)
T. Y. Lee
Crossover Design	142	(7)
Stephen Senn
Cutoff Designs	149	(8)
Joseph C. Cappelleri
William M. K. Trochim
Data Monitoring Board (DMB)	157	(10)
Walter W. Offen
Dose Proportionality	167	(3)
C. Gordon Law
Dropout	170	(6)
Cindy Rodenberg
Shu-Lin Cheng
Drug Development	176	(9)
Naitee Ting
Enrichment Design	185	(3)
Jen-pei Liu
Equivalence Trials	188	(6)
Jen-pei Liu
Ethnic Factors	194	(3)
Melody H. Lin
Helen McGough
Extra Variation Models	197	(13)
Jorge G. Morel
Nagaraj K. Neerchal
Factorial Designs	210	(14)
Junfang Li
Food and Drug Administration	224	(7)
Stacy R. David
Susan S. Ellenberg
Global Database and System	231	(6)
Alice T. M. Hsuan
Patrick Genyn
Good Programming Practice	237	(7)
Aileen L. Yam
Good Statistics Practice	244	(5)
Shein-Chung Chow
Group Sequential Methods	249	(10)
Weichung Joseph Shih
Individual Bioequivalence	259	(7)
Shein-Chung Chow
Jen-pei Liu
Integrated Summary Report	266	(5)
Laura J. Meyerson
Intention-to-Treat Analyses	271	(4)
Ronald K. Knickerbocker
International Conference on Harmonization (ICH)	275	(5)
Jen-pei Liu
Shein-Chung Chow
IVRS	280	(9)
Mon-Gy Chen
Lilly Reference Ranges	289	(18)
Michael G. Wilson
Meta-Analysis of Therapeutic Trials	307	(9)
Joseph C. Cappelleri
John P. A. Ioannidis
Joseph Lau
Mixed Effects Models	316	(5)
Donghui Zhang
A. Lawrence Could
Multicenter Trials	321	(4)
William J. Huster
Multiple Comparisons	325	(4)
Mani Y. Lakshminarayanan
Multiple-Dose Bioequivalence Studies	329	(4)
Vernon M. Chinchilli
William H. Barr
Multiple Endpoints	333	(12)
Mario Comelli
Parallel Design	345	(5)
Mani Y. Lakshminarayanan
Patient Compliance	350	(6)
Kenneth B. Schechtman
Pharmacodynamic Issues	356	(8)
Cheng-Tao Chang
Robert Wong
Pharmacodynamics with Covariates	364	(14)
Cheng-Tao Chang
Robert Wong
Pharmacodynamics with No Covariates	378	(9)
Cheng-Tao Chang
Robert Wong
Pharmacoeconomics	387	(15)
Joseph F. Heyse
John R. Cook
Michael F. Drummond
Placebo Effect	402	(5)
Thomas R. Stiger
Edward F. C. Pun
Postmarketing Surveillance	407	(9)
Patricia B. Cerrito
Power	416	(2)
Kenneth B. Schechtman
Protocol Development	418	(4)
Robert D. Chew
Process Validation	422	(19)
James Bergum
Merlin L. Utter
Release Targets	441	(4)
Greg C. G. Wei
Reproductive Studies	445	(8)
James J. Chen
Robust Analysis for Crossover Design	453	(16)
M. Mushfiqur Rashid
Sample Size Determination	469	(15)
Lilly Q. Yue
David Li
Shan Bai
Screening Design	484	(1)
John R. Murphy
Specifications	485	(2)
John R. Murphy
Stability Matrix Designs	487	(6)
Earl Nordbrock
Statistical Significance	493	(4)
Dieter Hauschke
Robert Schall
Herman G. Luus
Subgroup Analysis	497	(11)
Patricia B. Cerrito
Surrogate Endpoint	508	(7)
Shu Zhang
Edward F. C. Pun
Therapeutic Equivalence	515	(6)
Jen-pei Liu
Titration Design	521	(4)
Marilyn A. Agin
Edward F. C. Pun
USP Tests	525	(2)
John R. Murphy
Index	527