Research Catalog

Title

Encyclopedia of biopharmaceutical statistics / edited by Shein-Chung Chow.

Publication

New York : Marcel Dekker, c2003.

Items in the Library & Off-site

Details

Additional Authors

Chow, Shein-Chung, 1955-

Description

viii, 1055 p. : ill.; 29 cm.

Subject

• Pharmacology, Experimental > Statistical methods > Encyclopedias
• Drug development > Statistical methods > Encyclopedias
• Biopharmaceutics > methods
• Drug Design
• Data Interpretation, Statistical
• Statistics as Topic > methods
• Research Design

Bibliography (note)

• Includes bibliographical references and index.

Contents

• Acceptance Sampling / William A. Brenneman and William R. Myers -- Active Control Trials / George Y. H. Chi, Gang Chen, Mark Rothmann and Ning Li -- Adaptive Survival Trials / William F. Rosenberger -- Adjustment for Covariates / Thomas Permutt -- Adverse Event Reporting / Cynthia Pennise and Cheng-Tao Chang -- Ames Test / Wherly P. Hoffman and Michael L. Garriott -- Analysis of Heritability / Brent D. Burch and Ian R. Harris -- Analysis of Variance / Maria Overbeck-Larisch and Werner Sanns -- Assay Development / Timothy L. Schofield -- Assay Validation / Timothy L. Schofield -- Bayesian Statistics / Julia A. Varshavsky and Stacy R. Lindborg -- Bioassay / Anant M. Kshirsagar -- Bioavailability and Bioequivalence / Brian Smith -- Biologics / P. A. Lachenbruch, A. D. Horne, C. J. Lynch, J. Tiwari and Susan S. Ellenberg -- Biopharmaceutics / Iain J. McGilveray -- Blinding / Shein-Chung Chow and Jun Shao -- Bootstrap, The / Jun Shao -- Bracketing Design / John R. Murphy -- Bridging Studies / Jen-pei Liu -- Calibration / Shein-Chung Chow -- Canadian Health Products and Food Branch (HPFB) and Therapeutic Products Directorate (TPD) / Dongsheng Tu -- Cancer Trials / Clet Niyikiza and Douglas E. Faries -- Carcinogenicity Studies of Pharmaceuticals / Karl K. Lin -- Carry-Forward Analysis / Naitee Ting -- Clinical Data Management / Terri Madison and Marianne Plaunt -- Clinical Endpoint / Sofia Paul -- Clinical Pharmacology / Brian Smith -- Clinical Trial Process / Paul F. Kramer -- Clinical Trial Simulation / Hung-Ir Li and Pan-Yu Lai -- Clinical Trials / Kenneth B. Schechtman -- Combination Drug Clinical Trial / H. M. James Hung -- Comparing Variabilities in Clinical Research / Yonghee Lee, Hansheng Wang and Shein-Chung Chow -- Confidence Interval and Hypothesis Testing / Ivan S. F. Chan and Devan V. Mehrotra -- Confounding and Interaction / Catharine B. Stack -- Content Uniformity / John R. Murphy -- Contract Research Organization (CRO) / T. Y. Lee -- Cost-Effectiveness Analysis / Shahram Heshmat -- Crossover Design / Stephen Senn -- Cutoff Designs / Joseph C. Cappelleri and William M. K. Trochim -- Data Mining and Biopharmaceutical Research / Patricia B. Cerrito -- Data Monitoring Committees (DMC) / Walter W. Offen -- Diagnostic Imaging / Suming W. Chang and Annpey Pong -- Dose Proportionality / C. Gordon Law -- Dose Response Analysis in Clinical Trials / James MacDougall -- Dose Response Study Design / Naitee Ting -- 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 -- Expiration Dating Period / Annpey Pong -- Exploratory Factor Analysis / Joseph C. Cappelleri and Robert A. Gerber -- Extra Variation Models / Jorge G. Morel and Nagaraj K. Neerchal -- Factorial Designs / Junfang Li -- Food and Drug Administration / Stacy R. Lindborg and Susan S. Ellenberg -- Generalizability Probability in Clinical Research / Shein-Chung Chow -- Generalized Estimating Equation / Myunghee Cho Paik -- Global Database and System / Alice T. M. Hsuan and Patrick Genyn -- Good Clinical Practice / Mamoru Narukawa and Masahiro Takeuchi -- Good Programming Practice / Aileen L. Yam -- Good Statistics Practice / Shein-Chung Chow -- Group Sequential Methods / Weichung Joe Shih -- Hypothesis Testing / Devan V. Mehrotra and Ivan S. F. Chan -- Imputation in Clinical Research / Hansheng Wang -- Imputation with Item Nonrespondents / Hansheng Wang and Shein-Chung Chow -- In Vitro Bioequivalence Testing / Hansheng Wang, Ying Zhang, Jun Shao and Shein-Chung Chow -- In Vitro Dissolution Profile Comparison / Yi Tsong, Pradeep M. Sathe and Vinod P. Shah -- In Vitro Micronucleus Test / Wherly P. Hoffman, Michael L. Garriott and Cindy Lee -- Individual Bioequivalence / Shein-Chung Chow and Jen-pei Liu -- Instrument Development and Validation / Cindy Rodenberg, James T. Kuznicki and Gloria H. Yiu -- Integrated Summary Report / Laura J. Meyerson -- Intention-to-Treat Analyses (ITT) / Ronald K. Knickerbocker -- Interactive Voice Randomization System (IVRS) / Mon-Gy Chen -- Interim Analysis / Paul Gallo -- International Conference on Harmonization (ICH) / Jen-pei Liu and Shein-Chung Chow -- Investigating Quality-of-Life in Clinical Trials / Patricia B. Cerrito -- Kaplan-Meier Estimator / Hongyu Jiang and Jason Fine -- Laboratory Analyses / Michael J. Klepper -- Lilly Reference Ranges / Michael G. Wilson -- Logistic Regression / Rick Chappell and Jason Fine -- Maximum Tolerable Dose for Cancer Chemotherapy / Jen-pei Liu -- Measuring Agreement / Lawrence I-Kuei Lin -- MedDRA and Its Impact on Pharmaceutical Development / Keya T. Pitts -- Medical Devices / Greg Campbell, Lilly Q. Yue, Gene Pennello and Mary K. Barrick -- Meta-Analysis of Therapeutic Trials / Joseph C. Cappelleri, John P. A. Ioannidis and Joseph Lau -- Microarray Gene Expression / James J. Chen and Chun-Houh Chen -- Minimization Procedure / Dongsheng Tu -- Minimum Effective Dose / Jen-pei Liu -- Ministry of Health, Labour and Welfare and Pharmaceutical Administration in Japan / Kiyohito Nakai -- Mixed Effects Models / Donghui Zhang and A. Lawrence Gould -- Multicenter Trials / William J. Huster -- Multinational Clinical Trial / Thomas R. Weihrauch -- Multiple Comparisons / Mani Y. Lakshminarayanan -- Multiple-Dose Bioequivalence Studies / Vernon M. Chinchilli -- Multiple Endpoints / Mario Comelli -- Multiplicity in Clinical Trials / Peter Westfall and Frank Bretz -- Noninferiority Analysis in Active Controlled Clinical Trials / Sue-Jane Wang, H. M. James Hung and Yi Tsong -- Odds Ratio / Dongsheng Tu -- P-Values / Stephen Senn -- P-Values, Evidence and Multiplicity Considerations for Controlled Clinical Trials / M. F. Haque, M. Al-Osh and S. D. Dubey -- Parallel Design / Mani Y. Lakshminarayanan -- Patient Compliance / Kenneth B. Schechtman -- Pharmacodynamic Issues / Cheng-Tao Chang and Robert L. Wong -- Pharmacodynamics with Covariates / Cheng-Tao Chang and Robert L. Wong -- Pharmacodynamics with No Covariates / Cheng-Tao Chang and Robert L. Wong -- Pharmacoeconomics / Joseph Heyse, John R. Cook and Michael F. Drummond -- Placebo Effect / Thomas R. Stiger and Edward F. C. Pun -- Population Bioequivalence / Naitee Ting, Greg C. G. Wei and William W. B. Wang -- Postmarketing Adverse Drug Event Signaling / Yi Tsong -- Postmarketing Surveillance / Patricia B. Cerrito -- Power / Kenneth B. Schechtman -- Process Validation / James S. Bergum and Merlin L. Utter -- Proportional Hazards Regression Model / Bee Leng Lee and Jason Fine -- Protocol Development / Robert D. Chew -- Randomization / Shein-Chung Chow and Jun Shao -- Release Targets / Greg C. G. Wei -- Reproducibility Probability in Clinical Research / Shein-Chung Chow -- Reproductive/Developmental Studies / James J. Chen -- Response Surface Methodology / William R. Myers -- Robust Analysis for Crossover Design / M. Mushfiqur Rashid -- ROC Curve / Robert G. Lehr and Annpey Pong -- Sample Size Calculation for Survival Data / Qi Jiang, Steven Snapinn and Boris Iglewicz -- Sample Size Determination / Lilly Q. Yue, David Li and Shan Bai -- Sample Size Re-estimation Based on Observed Treatment Difference / Lu Cui -- Screening Design / John R. Murphy -- Selection of Control in Clinical Trials / Irving K. Hwang -- Specifications / John R. Murphy -- Stability Analysis for Frozen Drug Products / Shein-Chung Chow and Jun Shao -- Stability Matrix Designs / Earl Nordbrock -- Statistical Principles for Clinical Trials / Alan Phillips -- Statistical Process Control / William R. Myers and William A. Brenneman -- Statistical Significance / Dieter Hauschke, Robert Schall and Herman G. Luus -- Subgroup Analysis / Patricia B. Cerrito --
• Surrogate Endpoint / Shu Zhang and Edwad F. C. Pun -- Survival Analysis / Dirk F. Moore -- Therapeutic Equivalence / Jen-pei Liu -- Titration Design / Marilyn A. Agin and Edward F. C. Pun -- Toxicological Studies / Guenther Baus and Thomas Hofmann -- USP Tests / John R. Murphy -- Vaccine Clinical Trials / Ivan S. F. Chan, William W. B. Wang and Joseph Heyse -- Validity of LOCF / Bin Cheng and Shein-Chung Chow.

ISBN

• 0824742613 (print : alk. paper)
• 082474263X (print/online)
• 0824742621 (online)

LCCN

2003048980

OCLC

• ocm52109678
• SCSB-4812672

Owning Institutions

Columbia University Libraries