TY  - BOOK
AU  - Buncher,C.Ralph
AU  - Tsay,Jia-Yeong
TI  - Statistics in the pharmaceutical industry
T2  - Biostatics
SN  - 0824754697
AV  - RS57 .S8 2006
U1  - 615.1901072 22
PY  - 2006///
CY  - Boca Raton, FL
PB  - Chapman & Hall/CRC
KW  - Pharmacy
KW  - Statistical methods
KW  - Pharmaceutical industry
KW  - Drugs
KW  - Testing
N1  - Ch. 1; Introduction to the evolution of pharmaceutical products; C. Ralph Buncher and Jia-Yeong Tsay --; Ch. 2; Statistical review and evaluation of animal carcinogenicity studies of pharmaceuticals; Karl K. Lin and Mirza W. Ali --; Ch. 3; The FDA and the IND/NDA statistical review process; Satya D. Dubey, George Y. H. Chi and Roswitha E. Kelly --; Ch. 4; Clinical trial designs; C. Ralph Buncher and Jia-Yeong Tsay --; Ch. 5; Selecting patients for a clinical trial; C. Ralph Buncher and Jia-Yeong Tsay --; Ch. 6; Statistical aspects of cancer clinical trials; T. Timothy Chen --; Ch. 7; Recent statistical issues and developments in cancer clinical trials; Weichung Joe Shih --; Ch. 8; Design and analysis of testosterone replacement therapy trials; Ted M. Smith --; Ch. 9; Clinical trials of analgesic drugs; Cynthia G. McCormick --; Ch. 10; Statistical issues in HIV/AIDS research; Ronald J. Bosch and C. Ralph Buncher --; Ch. 11; The wonders of placebo; C. Ralph Buncher --; Ch. 12; Active-controlled noninferiority/equivalence trials : methods and practice; Irving K. Hwang --; Ch. 13; Interim analysis and bias in clinical trials : the adaptive design perspective; Qing Liu and Gordon Pledger --; Ch. 14; Interim analysis and adaptive design in clinical trials; Irving K. Hwang and K. K. Gordon Lan --; Ch. 15; A regulatory perspective on data monitoring and interim analysis; Robert T. O'Neill --; Ch. 16; Complex adaptive systems, human health, and drug response : statistical challenges in pharmacogenomics; Kim E. Zerba and C. Frank Shen --; Ch. 17; Phase IV postmarketing studies; C. Ralph Buncher and Jia-Yeong Tsay --; Ch. 18; The role of contract research organizations in clinical research in the pharmaceutical industry; Roger E. Flora and John Constant --; Ch. 19; Global harmonization of drug development - a clinical statistics perspective; Peter H. van Ewijk, Bernhard Huitfeldt and Jia-Yeong Tsay --; Ch. 20; Bridging strategies in global drug development; Mamoru Narukawa and Masahiro Takeuchi --; Ch. 21; Design and analysis strategies for clinical pharmacokinetic trials; Lianng Yuh and Yusong Chen --; Ch. 22; Stability studies of pharmaceuticals; Yi Tsong, Chi-wan Chen, Wen Jen Chen, Roswitha Kelly, Daphne T. Lin and Karl K. Lin --; Ch. 23; When and how to do multiple comparisons; Charles W. Dunnett and Charles H. Goldsmith --; Ch. 24; Reference intervals (ranges) : distribution-free methods vs. normal theory; Paul S. Horn and Amadeo J. Pesce
N2  - "Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies that discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, bridging strategies in global drug development, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies." "Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process."--BOOK JACKET
ER  -