Encyclopedia of biopharmaceutical statistics

1502 Pages·2010·59.504 MB·English

by  Chow, Shein Chung, Chow, Shein-Chung

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Encyclopedia of Biopharmaceutical Statistics
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Encyclopedia of Biopharmaceutical
Statistics
Third Edition
Revised and Expanded
Volume One
A–L
Edited by
Shein-Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, U.S.A.
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Firstpublishedin2000byInformaHealthcare,TelephoneHouse,69-77PaulStreet,LondonEC2A4LQ,UK.
Thiseditionpublishedin2010byInformaHealthcare,TelephoneHouse,69-77PaulStreet,LondonEC2A4LQ,UK.
SimultaneouslypublishedintheUSAbyInformaHealthcare,52VanderbiltAvenue,7thFloor,NewYork,NY10017,USA.
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Contents
Contributors.... xi BayesianMethodsin Meta-Analysis 116
Preface.... xvii ElizabethStojanovski and Kerrie L.Mengersen
VOLUME1 BayesianStatistics 122
JuliaA.Varshavsky and Stacy R.Lindborg
Acceptance Sampling 1
William A.Brenneman and WilliamR. Myers BayesianDesignsfor Phase II Oncology
ClinicalTrials 128
Active ControlTrials 8
SzeHuey Tan,David Machin, and Say BengTan
George Y. H.Chi, GangChen,Mark Rothmann, andNing Li
Binary232 Crossover Trials 136
AdaptiveDesign Methodsin ClinicalTrials 16
LiZhu,Juan Li,and EricChi
Shein-Chung Chowand AnnpeyPong
Bioassay 143
AdaptiveSurvivalTrials 28
AnantM.Kshirsagar
William F.Rosenberger and Lanju Zhang
BioavailabilityandBioequivalence 146
Adjustment for Covariates 30
BrianSmith
Thomas Permutt
Bioinformatics 151
Adverse EventReporting 33
SeanD.Mooney and JeffreyT. Chang
Cynthia Penniseand Cheng-Tao Chang
Biologics 158
AlphaSpending Function 38
P.A.Lachenbruch, A.D.Horne, C. J.Lynch,J.Tiwari,
Jihao Zhouand GlenAndrews
andSusan S.Ellenberg
AmesTest 45
BiomarkerinClinical Trials 167
WherlyP.Hoffman and Michael L.Garriott
Mark Chang
Analysis of23K Tables 52
Biopharmaceutics 170
ShivaGautam
IainJ.McGilveray
Analysis ofClustered BinaryData 58
BiosimilarityofFollow-On Biologics 186
Valerie Durkalski
Shein-ChungChow and Jen-pei Liu
Analysis ofClustered Categorical Data 63
Blinding 196
Kalyan Das
Shein-ChungChow and JunShao
Analysis ofHeritability 71
Bootstrap,The 202
Brent D. Burchand IanR. Harris
JunShao
Analysis ofRepeatedMeasures Data withMissing
Bracketing Design 207
Values: AnOverview ofMethods 76
JohnR. Murphy
Keumhee Carriere Chough,Yuanyuan Liang,and
TaesungPark BridgingStudies 208
Jen-peiLiu
Analysis ofVariance 82
Maria Overbeck-Larisch and WernerSanns Calibration 212
Shein-ChungChow
ANCOVAApproach for Premarketing Shelf Life
Determination withMultipleFactors 93 CanadianHealth Productsand FoodBranch (HPFB)
Yi Tsong,Chi-wan Chen,Wen Jen Chen,RoswithaE. Kelly, andTherapeutic Products Directorate(TPD) 219
DaphneT. Lin,and KarlK. Lin DongshengTu
AssayDevelopment 97 CancerTrials 223
Timothy L.Schofield CletNiyikiza and Douglas E.Faries
AssayValidation 104 Carcinogenicity StudiesofPharmaceuticals 230
Timothy L.Schofield KarlK. Lin
BayesianApproach to Stability Analysis 111 Carry-ForwardAnalysis 245
Jie Chen,JinglinZhong, and LeiNie NaiteeTing
v
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vi Contents
Case-ControlStudies, Inferencein 250 Cutoff Designs 386
GaryKingand LangcheZeng JosephC. Cappelleriand William M.K. Trochim
CenterWeighting in MulticenterTrials 260 Data Miningand BiopharmaceuticalResearch 392
PaulGallo Patricia B.Cerrito
ClinicalDataManagement 267 Data MonitoringCommittees(DMC) 397
TerriMadison and Marianne Plaunt Walter W.Offen
ClinicalEndpoint 273 Design andAnalysis for Demonstrating
SofiaPaul Disease Modification Effects 405
Djokouri A.Kouassiand AnnpeyPong
ClinicalPharmacology 276
BrianSmith Diagnostic Imaging 409
Suming W.Changand AnnpeyPong
ClinicalTrialProcess 279
PaulF. Kramer Dose Proportionality 415
C. GordonLaw
ClinicalTrialSimulation 282
Hung-IrLiand Pan-Yu Lai Dose Response Analysis inClinicalTrials 418
James MacDougall
ClinicalTrialSimulations for EarlierDevelopment
Phases 285 Dose Response StudyDesign 423
Mark Chang NaiteeTing
ClinicalTrialSimulations for LaterDevelopment Dropout 428
Phases 290 CindyRodenberg,Dan Schnell,and CameronS. Liu
Mark Chang
Drug Development 433
ClinicalTrials 297 NaiteeTing
KennethB.Schechtman
Ecologic Inference 439
ClusterTrials 304 SanderGreenland
JohnS. Preisser and BingLu
ED /ED 449
50 90
Clustered StudyDesigns: PowerAnalysis 312 YangxinHuang
J.Zhang,C. Feng,W.Tang, X.M.Tu,and J.Kowalski
Enrichment Design 456
CombinationDrug Clinical Trial 324 Jen-pei Liu
H.M. JamesHung
Equivalence Trials 459
Comparing Variabilitiesin ClinicalResearch 327 Jen-pei Liu
YongheeLee,Hansheng Wang,and Shein-Chung Chow
Ethnic Factors 464
ConfidenceInterval andHypothesis Testing 340 Melody H. Lin and Helen McGough
IvanS. F.Chan and DevanV.Mehrotra
On Evaluation ofLinearity inAssayValidation 467
Confoundingand Interaction 343 Jen-pei Liu and EricHsieh
Catharine B.Stack
Expiration DatingPeriod 475
ContentUniformity 348 AnnpeyPong
JohnR. Murphy
Exploratory FactorAnalysis 480
Contract ResearchOrganization (CRO) 351 JosephC. Cappelleriand Robert A.Gerber
T.Y. Lee
Extra Variation Models 486
CorrelatedProbit Model 355 JorgeG.Morel and Nagaraj K. Neerchal
Ralitza V.Gueorguieva
Factor Analysis 500
Cost-Effectiveness Analysis 363 Mary D.Sammel, Sarah J.Ratcliffe,and
ShahramHeshmat Benjamin E.Leiby
Covariate-AdjustedAdaptive Dose-Finding Factorial Designs 505
inEarly Phase ClinicalTrials 369 Junfang Li
PeterF. Thalland HoangQ. Nguyen
Failure-Time Model 516
CrossoverDesign 380 Chin-ShangLi
StephenSenn
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Contents vii
False DiscoveryRate (FDR) 522 InstrumentDevelopment andValidation 635
Avner Bar-Hen,Philippe Broet, CyrilDalmasso, CindyRodenberg,JamesT. Kuznicki, and
Jean-Jacques Daudin,and Stephane Robin GloriaH. Yiu
Food andDrug Administration 529 IntegratedSummary Report 646
Stacy R.Lindborg and SusanS.Ellenberg LauraJ.Meyerson
Generalizability Probabilityin ClinicalResearch 534 Intention-to-Treat Analyses(ITT) 650
Shein-Chung Chow RonaldK. Knickerbocker
GeneralizedEstimating Equation 537 InterimAnalysis 654
MyungheeChoPaik and Hye-Seung Lee PaulGallo
GeneralizedEstimating Equations (GEE)Method: InternationalConference onHarmonization (ICH) 659
Sample Size Estimation 543 Jen-peiLiu and Shein-Chung Chow
Sin-Ho Jung
InvestigatingQuality-of-Life in ClinicalTrials 663
GeneralizedInference 547 PatriciaB.Cerrito
Chen-TuoLiao andChi-Rong Li
IVRS/IWRS forRandomization 668
GeneticLinkageandLinkageDisequilibriumAnalysis 550 Mon-Gy Chen
Kongming Wang,Bernice Porjesz,Henri Begleiter, and
Kaplan–Meier Estimator 674
Kevin Jones
HongyuJiangand Jason Fine
GlobalDatabase andSystem 560
KappaCoefficients in MedicalResearch 679
AliceT. M.Hsuan and PatrickGenyn
HelenaChmura Kraemer
GoodClinicalPractice 565
Kullback–LeiblerDivergence for Evaluating
Mamoru Narukawa and Masahiro Takeuchi
Equivalence 686
GoodProgramming Practice 571 Vladimir Dragalin
AileenL. Yam
LaboratoryAnalyses 694
GoodStatistics Practice 577 MichaelJ.Klepper
Shein-Chung Chow
LatentClass Analysis 700
GroupSequential Methods 582 ElizabethS. Garrett-Mayer andJeannie-Marie S. Leoutsakos
Weichung JoeShih
LillyReferenceRanges 708
GroupSequential TestsandVariance Heterogeneity MichaelG.Wilson
in ClinicalTrials 590
LocalInfluence Analysis 722
Keumhee Carriere Chough,Abdulkadir Hussein,and
Nicola Sartori
TaesungPark
Hypotheses andFalse PositiveRatein Active Control LogisticRegression 725
Non-InferiorityTrials 595 RickChappell and JasonFine
GangChen,George Y.H. Chi,and Yong-Cheng Wang
LogisticRegressionin Three-Point Designs 730
Hypothesis Testing 601 Ma˚rten Va˚gero¨and Rolf Sundberg
DevanV.Mehrotra and Ivan S.F. Chan
VOLUME2
Imputation inClinical Research 604
MaximumTolerable Dosefor Cancer Chemotherapy 735
Hansheng Wangand Shein-Chung Chow
Jen-peiLiu
Imputation withItemNonrespondents 609
McNemar’sTest 740
Hansheng Wangand Shein-Chung Chow
Robert G.Lehr
InVitro BioequivalenceTesting 614
Measuring Agreement 745
Hansheng Wang,YingZhang, JunShao,and Shein-Chung Chow
LawrenceI-Kuei Lin
InVitro Dissolution ProfileComparison 620
MedDRAandItsImpacton Pharmaceutical
Yi Tsong,Pradeep M.Sathe,and Vinod P.Shah
Development 751
InVitro Micronucleus Test 625 KeyaT. Pitts
WherlyP.Hoffman, MichaelL. Garriott, and CindyLee
MedicalDevices 756
Individual Bioequivalence 629 GregCampbell,Lilly Q. Yue,Gene Pennello, and
Shein-Chung Chowand Jen-pei Liu MaryK. Barrick
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viii Contents
Meta-AnalysisofTherapeutic Trials 768 Noninferiority Analysis inActive Controlled
JosephC. Cappelleri,John P.A.Ioannidis, andJoseph Lau ClinicalTrials 904
Sue-Jane Wang,H. M.James Hung,and Yi Tsong
Microarray GeneExpression 780
JamesJ.Chen and Chun-HouhChen Non-parametric Regression 908
Kongming Wang and TheoGasser
MinimizationProcedure 795
DongshengTu Odds Ratio 917
Dongsheng Tu
MinimumEffective Dose 799
Jen-peiLiu OnsetofAction 922
Thomas R. Stigerand ChristyChuang-Stein
MinistryofHealth, LabourandWelfare and
Pharmaceutical Administrationin Japan 801 Ordered MultipleClass ReceiverOperating Characteristic
KiyohitoNakai (ROC)Analysis 929
Christos T. Nakasand Constantin T.Yiannoutsos
MissingValuesin RepeatedMeasurement Designs 808
KeumheeCarriere Chough,Yuanyuan Liang,RongHuang,and Outlier Detection in ClinicalResearch 933
XiaomingSheng Siu-Keung Tse andLiming Xiang
MixedEffects Models 813 P-Values 940
DonghuiZhang, ChunpengFan, and A.Lawrence Gould StephenSenn
Mixed-OutcomeData 817 P-Values,Evidence, andMultiplicity Considerations
A.R.de Leonand Keumhee Carriere Chough for Controlled ClinicalTrials 949
Mohammad F. Huque, Mohamed Alosh,
MMRMwithMissing Data 823
Satya D.Dubeyand Rafia Bhore
AnnpeyPong,Allen Lee,JunZhao, Phillip Phiri,and
LevSverdlov ParallelDesign 962
ManiY. Lakshminarayanan
Modified LargeSample Method 827
YongheeLee Patient Compliance 967
Kenneth B.Schechtman
Multicenter Trials 833
WilliamJ.Huster Percentile Charts on CorrelatedMeasures 972
XumingHeand Kai W.Ng
Multicollinearity 836
K.Van Steen and G.Molenberghs Pharmacodynamic Issues 976
Cheng-Tao Chang and Robert L.Wong
Multidimensional DataAnalysis:An Overview
ofPenalized RegressionMethods 844 Pharmacodynamics withCovariates 983
KeumheeCarriere Choughand Xiaoming Wang Cheng-Tao Chang and Robert L.Wong
Multinational ClinicalTrial 849 Pharmacodynamics withNoCovariates 993
Thomas R.Weihrauch Cheng-Tao Chang and Robert L.Wong
MultipleComparisons 855 Pharmacoeconomics 999
ManiY.Lakshminarayanan JosephHeyse, John R.Cook, andMichael F. Drummond
Multiple-DoseBioequivalence Studies 860 Phase I CancerClinical Trials 1011
VernonM.Chinchilli Seung-Ho Kangand ChulAhn
MultipleEndpoints 864 Placebo Effect 1016
MarioComelli Thomas R. Stigerand EdwardF. C. Pun
Multiple-stageDesigns for Phase IICancer Trials 872 PopulationBioequivalence 1020
MashaKocherginsky and ShangP.Lin NaiteeTing, GregC. G.Wei, and William W.B.Wang
MultiplicativeIntensityModels 882 PopulationPK/PD Analysis 1026
KeumheeCarriere Choughand Abdulkadir Hussein D. Concordet, C.Ane´,and F. Le´ger
Multiplicity in ClinicalTrials 889 Postmarketing Adverse Drug EventSignaling 1034
PeterWestfall andFrank Bretz Yi Tsong
Multivariate Meta-Analysis 897 Postmarketing Surveillance 1045
ElizabethStojanovski andKerrie L.Mengersen Patricia B.Cerrito
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Contents ix
Power 1052 ROCCurve 1185
KennethB. Schechtman Robert G.Lehrand AnnpeyPong
PredictionTrees 1054 SampleSize Calculation BasedonNonparametric
Antonio Ciampi Statistics 1192
HanshengWang and Shein-Chung Chow
Principal ComponentAnalysis 1061
AiyiLiu and EnriqueF. Schisterman SampleSize Calculation for SurvivalData 1200
QiJiang, StevenSnapinn, and Boris Iglewicz
Prior EffectiveSample Size ofa BayesianModel 1066
Satoshi Moritaand Peter F.Thall SampleSize Determination 1206
LillyQ. Yue, DavidLi,and ShanBai
Process Validation 1070
James S.Bergum and MerlinL. Utter SampleSize Re-estimation Based
onObserved Treatment Difference 1219
Profile Analysis 1083
LuCui
Bin Chengand Shein-Chung Chow
Screening Design 1223
Propensity Score Analysis andItsApplication
JohnR. Murphy
in RegulatorySettings 1088
LillyQ. Yue SelectionofControlin ClinicalTrials 1224
IrvingK.Hwang
ProportionofTreatment Effect 1090
CongChen and HongweiWang Semi-ParametricTime-Varying Regression Models 1229
Thomas H.Scheike
Proportional Hazards RegressionModel 1093
Bee LengLee and JasonFine SequentialEstimation for the AdditiveHazards
RateModelwithStaggeredEntry 1233
Protocol Development 1099
Laurent Bordesand Christelle Breuils
Robert D. Chew
SlopeApproach forAssessment ofDose Proportionality/
QT Analysis 1102 LinearityUnder aCrossover Design 1237
LangLi,StephenHall, and MehulDesai
BinCheng and Shein-ChungChow
Randomization 1110
Spatio-Temporal Modeling 1242
Shein-Chung Chowand JunShao
YingC. MacNab and Charmaine B.Dean
Rank-Based Robust Analysisfor Crossover Design 1114
Specifications 1251
M.Mushfiqur Rashid
JohnR. Murphy
Rank Regressionin Stability Analysis 1125
SROCCurve 1253
AnnpeyPong, YingQingChen,and XiudongLei S.D. Walterand Petra Macaskill
ReleaseTargets 1129
Stability Analysisfor Frozen Drug Products 1262
GregC. G.Wei Shein-ChungChow and JunShao
Reliability 1133 Stability MatrixDesigns 1266
ValentinRousson andTheo Gasser
EarlNordbrock
Reproducibility Probability inClinical Research 1141
StatisticalGenetics 1271
Shein-Chung Chow
RonglingWu, GuifangFu,and HongyingLi
Reproductive/Developmental Studies 1151
StatisticalPrinciples forClinical Trials 1278
James J.Chen
AlanPhillips
Response-Adaptive Designs 1157
StatisticalProcess Control 1282
FeifangHu andAnastasia Ivanova WilliamR. Myers andWilliam A.Brenneman
Response-Adaptive Repeated Measurement
StatisticalSignificance 1290
Designsfor ClinicalTrials 1162
DieterHauschke, Robert Schall,and Herman G.Luus
Keumhee Carriere Choughand Yuanyuan Liang
StatisticalTests for BiomarkerDevelopment with
Response Surface Methodology 1171
Applicationsto Genetics Data 1294
William R.Myers
GangZheng andJungnam Joo
Risk RatioAnalysis 1180
Structural EquationModel 1300
Kung-JongLui
JosepL.Carrasco
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x Contents
Stuart–MaxwellTest 1306 Translational Medicine: Concepts,
Jiang-MingJohnnyWu Statistical Methods, andRelatedIssues 1381
Siu-Keung Tse andShein-Chung Chow
Subgroup Analysis 1310
PatriciaB.Cerrito Trend Estimation 1392
JianQingShi and Man LaiTang
Subject-Treatment Interaction 1316
GaryL.Gadbury Two-StageDesign: Phase IICancer ClinicalTrials 1397
Sin-Ho Jung
SurrogateEndpoint 1322
ShuZhangand Edward F.C. Pun USP Tests 1401
John R.Murphy
SurvivalAnalysis 1326
DirkF. Moore Vaccine ClinicalTrials 1402
Ivan S.F. Chan, William W.B.Wang,and Joseph Heyse
TargetedClinicalTrials 1331
Jen-peiLiu Validation ofQuantitative andQualitative Assays 1416
BobZhong, Chunfu Qiu,and Dejun Tang
Testfor Ordered Categorical Data 1338
Shein-ChungChow,Siu-Keung Tse,and Chunyan Yang Validity ofLOCF 1427
Bin Chengand Shein-Chung Chow
Testing forQualitative Interaction 1343
XinYanand Xiaogang Su Z-Score 1433
Jiang-Ming JohnnyWu
Therapeutic Equivalence 1349
Jen-peiLiu Zero-Inflated Poisson Distribution 1436
Siu Keung Tse,Shein Chung Chow,and QingshuLu
TitrationDesign 1354
MarilynA.Aginand Edward F.C. Pun
Index....1443
Toxicological Studies 1358
GuentherBaus and Thomas Hofmann
TraditionalChinese Medicine—General
Consideration 1370
Shein-ChungChow,Annpey Pong,and Yu-WeiChang