Encyclopedia of Biopharmaceutical Statistics

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  • Format: Hardcover
  • Copyright: 2003-06-01
  • Publisher: Marcel Dekker Inc

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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.

Table of Contents

Prefacep. iii
Contributorsp. xi
Adjustment for Covariatesp. 1
Ames Testp. 4
Assay Developmentp. 13
Assay Validationp. 21
Bayesian Statisticsp. 31
Bioassayp. 39
Bioavailability and Bioequivalencep. 42
Biologicsp. 47
Biopharmaceuticsp. 54
Bracketing Designp. 77
Cancer Trialsp. 79
Carcinogenicity Studies of Pharmaceuticalsp. 88
Carry-Forward Analysisp. 103
Clinical Endpointp. 110
Clinical Pharmacologyp. 114
Clinical Trialsp. 117
Clinical Trial Processp. 125
Confounding and Interactionp. 128
Content Uniformityp. 134
Contract Research Organization (CRO)p. 137
Crossover Designp. 142
Cutoff Designsp. 149
Data Monitoring Board (DMB)p. 157
Dose Proportionalityp. 167
Dropoutp. 170
Drug Developmentp. 176
Enrichment Designp. 185
Equivalence Trialsp. 188
Ethnic Factorsp. 194
Extra Variation Modelsp. 197
Factorial Designsp. 210
Food and Drug Administrationp. 224
Global Database and Systemp. 231
Good Programming Practicep. 237
Good Statistics Practicep. 244
Group Sequential Methodsp. 249
Individual Bioequivalencep. 259
Integrated Summary Reportp. 266
Intention-to-Treat Analysesp. 271
International Conference on Harmonization (ICH)p. 275
IVRSp. 280
Lilly Reference Rangesp. 289
Meta-Analysis of Therapeutic Trialsp. 307
Mixed Effects Modelsp. 316
Multicenter Trialsp. 321
Multiple Comparisonsp. 325
Multiple-Dose Bioequivalence Studiesp. 329
Multiple Endpointsp. 333
Parallel Designp. 345
Patient Compliancep. 350
Pharmacodynamic Issuesp. 356
Pharmacodynamics with Covariatesp. 364
Pharmacodynamics with No Covariatesp. 378
Pharmacoeconomicsp. 387
Placebo Effectp. 402
Postmarketing Surveillancep. 407
Powerp. 416
Protocol Developmentp. 418
Process Validationp. 422
Release Targetsp. 441
Reproductive Studiesp. 445
Robust Analysis for Crossover Designp. 453
Sample Size Determinationp. 469
Screening Designp. 484
Specificationsp. 485
Stability Matrix Designsp. 487
Statistical Significancep. 493
Subgroup Analysisp. 497
Surrogate Endpointp. 508
Therapeutic Equivalencep. 515
Titration Designp. 521
USP Testsp. 525
Indexp. 527
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