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

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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.

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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

Acceptance Sampling1
Active Control Trials9
Adaptive Survival Trials16
Adjustment for Covariates18
Adverse Event Reporting22
Ames Test28
Analysis of Heritability36
Analysis of Variance42
Assay Development55
Assay Validation63
Bayesian Statistics72
Bioassay80
Bioavailability and Bioequivalence83
Biologics89
Biopharmaceutics100
Blinding121
Bootstrap, The127
Bracketing Design133
Bridging Studies134
Calibration139
Canadian Health Products and Food Branch (HPFB) and Therapeutic Products Directorate (TPD)147
Cancer Trials152
Carcinogenicity Studies of Pharmaceuticals160
Carry-Foward Analysis175
Clinical Data Management181
Clinical Endpoint189
Clinical Pharmacology193
Clinical Trial Process196
Clinical Trial Simulation200
Clinical Trials202
Combination Drug Clinical Trial210
Comparing Variabilities in Clinical Research214
Confidence Interval and Hypothesis Testing231
Confounding and Interaction235
Content Uniformity241
Contract Research Organization (CRO)244
Cost-Effectiveness Analysis249
Crossover Design255
Cutoff Designs263
Data Mining and Biopharmaceutical Research270
Data Monitoring Committees (DMC)277
Diagnostic Imaging288
Dose Proportionality295
Dose Response Analysis in Clinical Trials298
Dose Response Study Design304
Dropout311
Drug Development317
Enrichment Design324
Equivalence Trials327
Ethnic Factors333
Expiration Dating Period336
Exploratory Factor Analysis343
Extra Variation Models349
Factorial Designs364
Food and Drug Administration379
Generalizability Probability in Clinical Research386
Generalized Estimating Equation390
Global Database and System397
Good Clinical Practice403
Good Programming Practice410
Good Statistics Practice417
Group Sequential Methods423
Hypothesis Testing433
Imputation in Clinical Research437
Imputation with Item Nonrespondents443
In Vitro Bioequivalence Testing449
In Vitro Dissolution Profile Comparison456
In Vitro Micronucleus Test463
Individual Bioequivalence468
Instrument Development and Validation476
Integrated Summary Report486
Intention-to-Treat Analyses (ITT)490
Interactive Voice Randomization System (IVRS)494
Interim Analysis502
International Conference on Harmonization (ICH)508
Investigating Quality-of-Life in Clinical Trials512
Kaplan-Meier Estimator518
Laboratory Analyses524
Lilly Reference Ranges532
Logistic Regression548
Maximum Tolerable Dose for Cancer Chemotherapy554
Measuring Agreement561
MedDRA and Its Impact on Pharmaceutical Development568
Medical Devices574
Meta-Analysis of Therapeutic Trials586
Microarray Gene Expression599
Minimization Procedure614
Minimum Effective Dose619
Ministry of Health, Labour and Welfare and Pharmaceutical Administration in Japan622
Mixed Effects Models630
Multicenter Trials635
Multinational Clinical Trial639
Multiple Comparisons647
Multiple-Dose Bioequivalence Studies652
Multiple Endpoints656
Multiplicity in Clinical Trials666
Noninferiority Analysis in Active Controlled Clinical Trials674
Odds Ratio678
P-Values685
P-Values, Evidence and Multiplicity Considerations for Controlled Clinical Trials696
Parallel Design707
Patient Compliance712
Pharmacodynamic Issues718
Pharmacodynamics with Covariates727
Pharmacodynamics with No Covariates740
Pharmacoeconomics749
Placebo Effect764
Population Bioequivalence769
Postmarketing Adverse Drug Event Signaling776
Postmarketing Surveillance790
Power798
Process Validation800
Proportional Hazards Regression Model816
Protocol Development824
Randomization828
Release Targets833
Reproducibility Probability in Clinical Research838
Reproductive/Developmental Studies850
Response Surface Methodology858
Robust Analysis for Crossover Design870
ROC Curve884
Sample Size Calculation for Survival Data892
Sample Size Determination899
Sample Size Re-estimation Based on Observed Treatment Difference915
Screening Design920
Selection of Control in Clinical Trials921
Specifications927
Stability Analysis for Frozen Drug Products929
Stability Matrix Designs934
Statistical Principles for Clinical Trials940
Statistical Process Control945
Statistical Significance954
Subgroup Analysis959
Surrogate Endpoint967
Survival Analysis972
Therapeutic Equivalence977
Titration Design983
Toxicological Studies988
USP Tests1003
Vaccine Clinical Trials1005
Validity of LOCF1023

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