Encyclopedia of Biopharmaceutical Statistics

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Overview

Available in both print and online versions, this is the definitive statistics reference for biopharmaceutical research and manufacturing, presenting current standards and best practices for the laboratory, manufacturing, and statistical design, investigation, and analysis. Thoroughly exploring emerging technologies, concepts, and trends, this second edition incorporates 69 new sections on subjects ranging from in vitro bioequivalence testing and dissolution profile comparison to bridging studies, MedDRA, vaccine clinical trials, and medical devices. It reviews recent amendments to regulatory requirements and presents newer statistical methods applicable to the drug development, review, and approval processes.

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Editorial Reviews

Booknews
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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Product Details

  • ISBN-13: 9780824760014
  • Publisher: CRC Press
  • Publication date: 3/28/2000
  • Pages: 552

Table of Contents

Acceptance Sampling 1
Active Control Trials 9
Adaptive Survival Trials 16
Adjustment for Covariates 18
Adverse Event Reporting 22
Ames Test 28
Analysis of Heritability 36
Analysis of Variance 42
Assay Development 55
Assay Validation 63
Bayesian Statistics 72
Bioassay 80
Bioavailability and Bioequivalence 83
Biologics 89
Biopharmaceutics 100
Blinding 121
Bootstrap, The 127
Bracketing Design 133
Bridging Studies 134
Calibration 139
Canadian Health Products and Food Branch (HPFB) and Therapeutic Products Directorate (TPD) 147
Cancer Trials 152
Carcinogenicity Studies of Pharmaceuticals 160
Carry-Foward Analysis 175
Clinical Data Management 181
Clinical Endpoint 189
Clinical Pharmacology 193
Clinical Trial Process 196
Clinical Trial Simulation 200
Clinical Trials 202
Combination Drug Clinical Trial 210
Comparing Variabilities in Clinical Research 214
Confidence Interval and Hypothesis Testing 231
Confounding and Interaction 235
Content Uniformity 241
Contract Research Organization (CRO) 244
Cost-Effectiveness Analysis 249
Crossover Design 255
Cutoff Designs 263
Data Mining and Biopharmaceutical Research 270
Data Monitoring Committees (DMC) 277
Diagnostic Imaging 288
Dose Proportionality 295
Dose Response Analysis in Clinical Trials 298
Dose Response Study Design 304
Dropout 311
Drug Development 317
Enrichment Design 324
Equivalence Trials 327
Ethnic Factors 333
Expiration Dating Period 336
Exploratory Factor Analysis 343
Extra Variation Models 349
Factorial Designs 364
Food and Drug Administration 379
Generalizability Probability in Clinical Research 386
Generalized Estimating Equation 390
Global Database and System 397
Good Clinical Practice 403
Good Programming Practice 410
Good Statistics Practice 417
Group Sequential Methods 423
Hypothesis Testing 433
Imputation in Clinical Research 437
Imputation with Item Nonrespondents 443
In Vitro Bioequivalence Testing 449
In Vitro Dissolution Profile Comparison 456
In Vitro Micronucleus Test 463
Individual Bioequivalence 468
Instrument Development and Validation 476
Integrated Summary Report 486
Intention-to-Treat Analyses (ITT) 490
Interactive Voice Randomization System (IVRS) 494
Interim Analysis 502
International Conference on Harmonization (ICH) 508
Investigating Quality-of-Life in Clinical Trials 512
Kaplan-Meier Estimator 518
Laboratory Analyses 524
Lilly Reference Ranges 532
Logistic Regression 548
Maximum Tolerable Dose for Cancer Chemotherapy 554
Measuring Agreement 561
MedDRA and Its Impact on Pharmaceutical Development 568
Medical Devices 574
Meta-Analysis of Therapeutic Trials 586
Microarray Gene Expression 599
Minimization Procedure 614
Minimum Effective Dose 619
Ministry of Health, Labour and Welfare and Pharmaceutical Administration in Japan 622
Mixed Effects Models 630
Multicenter Trials 635
Multinational Clinical Trial 639
Multiple Comparisons 647
Multiple-Dose Bioequivalence Studies 652
Multiple Endpoints 656
Multiplicity in Clinical Trials 666
Noninferiority Analysis in Active Controlled Clinical Trials 674
Odds Ratio 678
P-Values 685
P-Values, Evidence and Multiplicity Considerations for Controlled Clinical Trials 696
Parallel Design 707
Patient Compliance 712
Pharmacodynamic Issues 718
Pharmacodynamics with Covariates 727
Pharmacodynamics with No Covariates 740
Pharmacoeconomics 749
Placebo Effect 764
Population Bioequivalence 769
Postmarketing Adverse Drug Event Signaling 776
Postmarketing Surveillance 790
Power 798
Process Validation 800
Proportional Hazards Regression Model 816
Protocol Development 824
Randomization 828
Release Targets 833
Reproducibility Probability in Clinical Research 838
Reproductive/Developmental Studies 850
Response Surface Methodology 858
Robust Analysis for Crossover Design 870
ROC Curve 884
Sample Size Calculation for Survival Data 892
Sample Size Determination 899
Sample Size Re-estimation Based on Observed Treatment Difference 915
Screening Design 920
Selection of Control in Clinical Trials 921
Specifications 927
Stability Analysis for Frozen Drug Products 929
Stability Matrix Designs 934
Statistical Principles for Clinical Trials 940
Statistical Process Control 945
Statistical Significance 954
Subgroup Analysis 959
Surrogate Endpoint 967
Survival Analysis 972
Therapeutic Equivalence 977
Titration Design 983
Toxicological Studies 988
USP Tests 1003
Vaccine Clinical Trials 1005
Validity of LOCF 1023
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