{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T05:27:26Z","timestamp":1735709246926,"version":"3.32.0"},"reference-count":136,"publisher":"Elsevier","isbn-type":[{"type":"print","value":"9780444820617"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[1996]]},"DOI":"10.1016\/s0169-7161(96)13004-2","type":"book-chapter","created":{"date-parts":[[2005,4,18]],"date-time":"2005-04-18T19:58:53Z","timestamp":1113854333000},"page":"31-62","source":"Crossref","is-referenced-by-count":4,"title":["2 Clinical trials in drug development: Some statistical issues"],"prefix":"10.1016","author":[{"given":"H.I.","family":"Patel","sequence":"first","affiliation":[]}],"member":"78","reference":[{"key":"10.1016\/S0169-7161(96)13004-2_bib1","doi-asserted-by":"crossref","first-page":"2663","DOI":"10.1080\/03610928308828634","article-title":"A new procedure for testing equivalence in comparative bioavailability and other clinical trials","volume":"12","author":"Anderson","year":"1983","journal-title":"Comm. Statist. Theory Methods"},{"key":"10.1016\/S0169-7161(96)13004-2_bib2","doi-asserted-by":"crossref","first-page":"259","DOI":"10.1007\/BF01062202","article-title":"Consideration of individual bioequivalence","volume":"18","author":"Anderson","year":"1990","journal-title":"J. Pharmacokinetics and Biopharmaceutics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib3","doi-asserted-by":"crossref","first-page":"200","DOI":"10.1080\/01621459.1957.10501379","article-title":"Maximum likelihood estimates for a multivariate distribution when some observations are missing","volume":"57","author":"Anderson","year":"1957","journal-title":"J. Amer. Statist. Assoc."},{"key":"10.1016\/S0169-7161(96)13004-2_bib4","first-page":"119","article-title":"The assessment of low-dose carcinogenicity","volume":"38","author":"Armitage","year":"1982"},{"key":"10.1016\/S0169-7161(96)13004-2_bib5","doi-asserted-by":"crossref","first-page":"767","DOI":"10.1093\/biomet\/81.4.767","article-title":"Logistic regression for autocorrelated data with application to repeated measures","volume":"81","author":"Azzalini","year":"1994","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib6","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1080\/00401706.1988.10488406","article-title":"Heteroscedastic nonlinear regression","volume":"30","author":"Beal","year":"1988","journal-title":"Technometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib7","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1111\/j.2517-6161.1975.tb01037.x","article-title":"Missing values in multivariate analysis","volume":"37","author":"Beale","year":"1975","journal-title":"J. Roy. Statist. Soc. Ser. B"},{"key":"10.1016\/S0169-7161(96)13004-2_bib8","doi-asserted-by":"crossref","first-page":"991","DOI":"10.2307\/2530970","article-title":"A mixed effects model for categorical data","volume":"41","author":"Beitler","year":"1985","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib9","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1007\/BF02504652","article-title":"Some one-sample testing problems when there is a monotone sample from a multivariate normal population","volume":"27","author":"Bhargava","year":"1975","journal-title":"Ann. Inst. Statist. Math."},{"key":"10.1016\/S0169-7161(96)13004-2_bib10","doi-asserted-by":"crossref","first-page":"38","DOI":"10.2307\/2347661","article-title":"Extra-Poisson variation in log-linear models","volume":"33","author":"Breslow","year":"1984","journal-title":"Appl. Statist."},{"key":"10.1016\/S0169-7161(96)13004-2_bib11","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1002\/sim.4780090709","article-title":"A Markovian model for comparing incidences of side effects","volume":"9","author":"Bristol","year":"1990","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib12","doi-asserted-by":"crossref","first-page":"850","DOI":"10.1080\/01621459.1983.10477031","article-title":"Inference about multivariate means for a nonstationary Autoregressive model","volume":"78","author":"Byrne","year":"1983","journal-title":"J. Amer. Statist. Assoc."},{"key":"10.1016\/S0169-7161(96)13004-2_bib13","doi-asserted-by":"crossref","first-page":"779","DOI":"10.2307\/2532199","article-title":"An evaluation of some methods for fitting dose-response models to quantal-response developmental toxicology data","volume":"49","author":"Carr","year":"1993","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib14","doi-asserted-by":"crossref","first-page":"703","DOI":"10.2307\/2531290","article-title":"Analysis of parallel-line assays with multivariate responses","volume":"41","author":"Carter","year":"1985","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib15","doi-asserted-by":"crossref","first-page":"325","DOI":"10.2307\/2529424","article-title":"Analysis of data from multiclinic experiments","volume":"31","author":"Chakravorti","year":"1975","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib16","series-title":"Proc. Amer. Statist. Assoc., Biopharmaceutical Section","article-title":"Dose response studies and special populations","author":"Chi","year":"1994"},{"key":"10.1016\/S0169-7161(96)13004-2_bib17","doi-asserted-by":"crossref","first-page":"452","DOI":"10.1080\/01621459.1989.10478790","article-title":"Models for longitudinal data with random effects and AR(1) errors","volume":"84","author":"Chi","year":"1989","journal-title":"J. Amer. Statist. Assoc."},{"year":"1992","series-title":"Design and Analysis of Bioavailability and Bioequivalence Studies","author":"Chow","key":"10.1016\/S0169-7161(96)13004-2_bib18"},{"key":"10.1016\/S0169-7161(96)13004-2_bib19","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1002\/sim.4780060507","article-title":"The analysis of titration study","volume":"6","author":"Chuang","year":"1987","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib20","doi-asserted-by":"crossref","first-page":"810","DOI":"10.2307\/2528076","article-title":"Applications of multivariate analysis of variance to repeated measures experiments","volume":"22","author":"Cole","year":"1966","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib21","doi-asserted-by":"crossref","first-page":"693","DOI":"10.1126\/science.910152","article-title":"Carcinogenic risk assessment","volume":"198","author":"Cornfield","year":"1977","journal-title":"Science"},{"year":"1970","series-title":"Analysis of Binary Data","author":"Cox","key":"10.1016\/S0169-7161(96)13004-2_bib22"},{"key":"10.1016\/S0169-7161(96)13004-2_bib23","doi-asserted-by":"crossref","first-page":"1","DOI":"10.2307\/1403235","article-title":"Interaction","volume":"52","author":"Cox","year":"1985","journal-title":"Internat. Statist. Rev."},{"key":"10.1016\/S0169-7161(96)13004-2_bib24","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1111\/j.2517-6161.1985.tb01349.x","article-title":"Gaussian estimation for correlated binary data","volume":"47","author":"Crowder","year":"1985","journal-title":"J. Roy. Statist. Soc. Ser. B"},{"key":"10.1016\/S0169-7161(96)13004-2_bib25","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1111\/j.2517-6161.1977.tb01600.x","article-title":"Maximum likelihood from incomplete data via the EM algorithm (with discussion)","volume":"39","author":"Dempster","year":"1977","journal-title":"J. Roy. Statist. Soc. Ser. B"},{"key":"10.1016\/S0169-7161(96)13004-2_bib26","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1016\/0197-2456(86)90046-2","article-title":"Meta-analysis in clinical trials","volume":"7","author":"Dersimonian","year":"1986","journal-title":"Contr. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13004-2_bib27","doi-asserted-by":"crossref","first-page":"959","DOI":"10.2307\/2531727","article-title":"An approach to the analysis of repeated measurements","volume":"44","author":"Diggle","year":"1988","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib28","doi-asserted-by":"crossref","first-page":"49","DOI":"10.2307\/2986113","article-title":"Informative dropout in longitudinal data analysis (with discussion)","volume":"43","author":"Diggle","year":"1994","journal-title":"Appl. Statist."},{"year":"1994","series-title":"Analysis of Longitudinal Data","author":"Diggle","key":"10.1016\/S0169-7161(96)13004-2_bib29"},{"key":"10.1016\/S0169-7161(96)13004-2_bib30","series-title":"Statistical Methodology in the Pharmaceutical Sciences","article-title":"Dose-response: Relating doses and plasma levels to efficacy and adverse experiences","author":"Ekholm","year":"1990"},{"key":"10.1016\/S0169-7161(96)13004-2_bib31","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1080\/10543409408835071","article-title":"Extension to the use of tolerance intervals for the assessment of individual bioequivalence","volume":"4","author":"Esinhart","year":"1994","journal-title":"J. Biopharm. Statist."},{"key":"10.1016\/S0169-7161(96)13004-2_bib32","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1111\/j.2517-6161.1954.tb00159.x","article-title":"Some problems in interval estimation (with discussion)","volume":"16","author":"Fieller","year":"1954","journal-title":"J. Roy. Statist. Soc. Ser. B"},{"year":"1971","series-title":"Statistical Methods in Biological Assay","author":"Finney","key":"10.1016\/S0169-7161(96)13004-2_bib33"},{"key":"10.1016\/S0169-7161(96)13004-2_bib34","doi-asserted-by":"crossref","first-page":"601","DOI":"10.2307\/2532775","article-title":"Analyzing incomplete longitudinal binary responses: A likelihood-based approach","volume":"50","author":"Fitzmaurice","year":"1994","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib35","doi-asserted-by":"crossref","first-page":"248","DOI":"10.1214\/ss\/1177010899","article-title":"Regression models for discrete longitudinal data (with discussion)","volume":"8","author":"Fitzmaurice","year":"1993","journal-title":"Statist. Sci."},{"key":"10.1016\/S0169-7161(96)13004-2_bib36","volume":"21","author":"FDA","year":"1985","journal-title":"Code of Federal Regulations"},{"key":"10.1016\/S0169-7161(96)13004-2_bib37","doi-asserted-by":"crossref","first-page":"201","DOI":"10.1214\/aoms\/1177704724","article-title":"Ante-dependence analysis of an ordered set of variables","volume":"33","author":"Gabriel","year":"1962","journal-title":"Ann. Math. Statist."},{"key":"10.1016\/S0169-7161(96)13004-2_bib38","doi-asserted-by":"crossref","first-page":"1087","DOI":"10.2307\/2532450","article-title":"Exact tests for the random and fixed effects in an unbalanced mixed two-way cross-classification model","volume":"46","author":"Gallo","year":"1990","journal-title":"Biometrics"},{"year":"1982","series-title":"Pharmacokinetics","author":"Gibardi","key":"10.1016\/S0169-7161(96)13004-2_bib39"},{"key":"10.1016\/S0169-7161(96)13004-2_bib40","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1093\/biomet\/72.3.593","article-title":"The analysis of binomial data by a generalized linear mixed model","volume":"72","author":"Gilmour","year":"1985","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib41","doi-asserted-by":"crossref","first-page":"467","DOI":"10.2307\/2528104","article-title":"The two-period change-over design and its use in clinical trials","volume":"21","author":"Grizzle","year":"1965","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib42","doi-asserted-by":"crossref","first-page":"357","DOI":"10.2307\/2528795","article-title":"Analysis of growth and dose-response curves","volume":"25","author":"Grizzle","year":"1969","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib43","doi-asserted-by":"crossref","first-page":"783","DOI":"10.2307\/2528820","article-title":"The analysis of incomplete data","volume":"27","author":"Hartley","year":"1971","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib44","doi-asserted-by":"crossref","first-page":"320","DOI":"10.1080\/01621459.1977.10480998","article-title":"Maximum likelihood approaches to variance component estimation and to related problems","volume":"72","author":"Harville","year":"1977","journal-title":"J. Amer. Statist. Assoc."},{"key":"10.1016\/S0169-7161(96)13004-2_bib45","first-page":"72","article-title":"A distribution-free procedure for the statistical analysis of bioequivalence studies","volume":"28","author":"Hauschke","year":"1990","journal-title":"Internat. J. Clinical Pharmacology, Therapy and Toxicology"},{"key":"10.1016\/S0169-7161(96)13004-2_bib46","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1111\/j.1365-2125.1979.tb05903.x","article-title":"The two period crossover clinical trial","volume":"8","author":"Hills","year":"1979","journal-title":"British J. Clinical Pharmacology"},{"key":"10.1016\/S0169-7161(96)13004-2_bib47","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1093\/biomet\/81.1.103","article-title":"Confidence intervals associated with tests for bioequivalence","volume":"81","author":"Hsu","year":"1994","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib48","series-title":"Biopharmaceutical Statistics for Drug Development","article-title":"Assessment of Pharmacological activity","author":"Hubert","year":"1988"},{"key":"10.1016\/S0169-7161(96)13004-2_bib49","doi-asserted-by":"crossref","first-page":"805","DOI":"10.2307\/2530695","article-title":"Unbalanced repeated measures models with structured covariance matrices","volume":"42","author":"Jennrich","year":"1986","journal-title":"Biometrics"},{"year":"1989","series-title":"Design and Analysis of Cross-over Trials","author":"Jones","key":"10.1016\/S0169-7161(96)13004-2_bib50"},{"key":"10.1016\/S0169-7161(96)13004-2_bib51","series-title":"Bull. Internat. Statist. Inst. Proc. 46th Session","first-page":"105","article-title":"Serial correlation in unbalanced mixed models","author":"Jones","year":"1987"},{"year":"1993","series-title":"Longitudinal Data with Serial Correlation: A State-Space Approach","author":"Jones","key":"10.1016\/S0169-7161(96)13004-2_bib52"},{"key":"10.1016\/S0169-7161(96)13004-2_bib53","doi-asserted-by":"crossref","first-page":"161","DOI":"10.2307\/2532504","article-title":"Unequally spaced longitudinal data with AR(1) serial correlation","volume":"47","author":"Jones","year":"1991","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib54","doi-asserted-by":"crossref","first-page":"296","DOI":"10.2307\/2347788","article-title":"A method for comparing profiles of repeated measurements","volume":"36","author":"Kenward","year":"1987","journal-title":"Appl. Statist."},{"key":"10.1016\/S0169-7161(96)13004-2_bib55","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1080\/10543409208835036","article-title":"Alternative approaches to the analysis of binary and categorical repeated measurements","volume":"2","author":"Kenward","year":"1992","journal-title":"J. Biopharm. Statist."},{"key":"10.1016\/S0169-7161(96)13004-2_bib56","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1007\/BF02869518","article-title":"A note on a MANOVA model applied to problems in growth curves","volume":"18","author":"Khatri","year":"1966","journal-title":"Ann. Inst. Statist. Math."},{"key":"10.1016\/S0169-7161(96)13004-2_bib57","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1080\/03610929208830762","article-title":"Analysis of a multicenter trial using a multivariate approach to a mixed linear model","volume":"21","author":"Khatri","year":"1992","journal-title":"Comm. Statist. Theory Methods"},{"key":"10.1016\/S0169-7161(96)13004-2_bib58","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1016\/0047-259X(73)90015-8","article-title":"A generalization of the growth curve model which allows missing data","volume":"3","author":"Kleinbaum","year":"1973","journal-title":"J. Multivariate Anal."},{"key":"10.1016\/S0169-7161(96)13004-2_bib59","doi-asserted-by":"crossref","first-page":"133","DOI":"10.2307\/2529309","article-title":"A general methodology for the analysis of experiments with repeated measurements of categorical data","volume":"33","author":"Koch","year":"1977","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib60","doi-asserted-by":"crossref","first-page":"1799","DOI":"10.1002\/sim.4780131802","article-title":"A comparison of two Phase I trial designs","volume":"13","author":"Korn","year":"1994","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib61","doi-asserted-by":"crossref","first-page":"353","DOI":"10.2307\/2530423","article-title":"Carcinogenic risk assessment: A guide to the literature","volume":"37","author":"Krewski","year":"1981","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib62","doi-asserted-by":"crossref","first-page":"963","DOI":"10.2307\/2529876","article-title":"Random-effects models for longitudinal data","volume":"38","author":"Laird","year":"1982","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib63","doi-asserted-by":"crossref","first-page":"1139","DOI":"10.2307\/2531766","article-title":"Testing whether the identified treatment is best","volume":"45","author":"Laska","year":"1989","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib64","doi-asserted-by":"crossref","first-page":"757","DOI":"10.1080\/01621459.1991.10475106","article-title":"Sequential comparison of changes with repeated measurements data","volume":"86","author":"Lee","year":"1991","journal-title":"J. Amer. Statist. Assoc."},{"key":"10.1016\/S0169-7161(96)13004-2_bib65","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1093\/biomet\/73.1.13","article-title":"Longitudinal data analysis using generalized linear models","volume":"73","author":"Liang","year":"1986","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib66","doi-asserted-by":"crossref","first-page":"673","DOI":"10.2307\/2532087","article-title":"Nonlinear mixed effects models for repeated measures data","volume":"46","author":"Lindstorm","year":"1990","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib67","doi-asserted-by":"crossref","first-page":"1149","DOI":"10.1002\/sim.4780131106","article-title":"Analysis of repeated categorical data using generalized estimating equations","volume":"13","author":"Lipsitz","year":"1994","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib68","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1093\/biomet\/78.1.153","article-title":"Generalized estimating equations for correlated binary data: Using the odds ratio as a measure of association","volume":"78","author":"Lipsitz","year":"1991","journal-title":"Biometrika"},{"year":"1993","series-title":"Random Coefficient Models","author":"Longford","key":"10.1016\/S0169-7161(96)13004-2_bib69"},{"key":"10.1016\/S0169-7161(96)13004-2_bib70","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/0167-9473(92)00062-V","article-title":"Logistic regression with random coefficients","volume":"17","author":"Longford","year":"1994","journal-title":"Comput. Statist. Data Anal."},{"key":"10.1016\/S0169-7161(96)13004-2_bib71","doi-asserted-by":"crossref","first-page":"213","DOI":"10.2307\/2530412","article-title":"Comparison of different methods for decision-making in bioequivalence assessment","volume":"37","author":"Mandallaz","year":"1981","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib72","doi-asserted-by":"crossref","first-page":"117","DOI":"10.2307\/1403636","article-title":"Recent developments in crossover designs","volume":"56","author":"Matthews","year":"1988","journal-title":"Internat. Statist. Rev."},{"key":"10.1016\/S0169-7161(96)13004-2_bib73","doi-asserted-by":"crossref","first-page":"689","DOI":"10.2307\/2532088","article-title":"The analysis of data from crossover designs: The efficiency of ordinary least squares","volume":"46","author":"Matthews","year":"1990","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib74","doi-asserted-by":"crossref","first-page":"917","DOI":"10.2307\/2532213","article-title":"A measure of tumorigenic potency incorporating dose-response shape","volume":"49","author":"Meier","year":"1993","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib75","doi-asserted-by":"crossref","first-page":"309","DOI":"10.2307\/2529651","article-title":"Bioavailability: A problem in equivalence","volume":"30","author":"Metzler","year":"1974","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib76","doi-asserted-by":"crossref","first-page":"941","DOI":"10.1002\/sim.4780070905","article-title":"Correcting for the bias caused by drop-outs in hypertension trials","volume":"7","author":"Murray","year":"1988","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib77","doi-asserted-by":"crossref","first-page":"531","DOI":"10.1093\/biomet\/71.3.531","article-title":"Likelihood inference in a correlated probit regression model","volume":"71","author":"Ochi","year":"1984","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib78","first-page":"6067","article-title":"In vivo bioequivalence guidences","volume":"19","author":"OGD","year":"1993","journal-title":"Pharmacopeial Forum"},{"key":"10.1016\/S0169-7161(96)13004-2_bib79","doi-asserted-by":"crossref","first-page":"1647","DOI":"10.1002\/sim.4780101104","article-title":"Methods for dose finding studies in cancer trials: A review and results of a Monte Carlo study","volume":"10","author":"O'Quigley","year":"1991","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib80","doi-asserted-by":"crossref","first-page":"33","DOI":"10.2307\/2531628","article-title":"Continual reassessment method: A practical design for Phase I clinical trials in cancer","volume":"46","author":"O'Quigley","year":"1990","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib81","series-title":"Proc. Fourth Conference of the SAS Users Group, International","first-page":"84","article-title":"Analysis of covariance of incomplete data on experiments with repeated measurements in clinical trials","author":"Patel","year":"1979"},{"key":"10.1016\/S0169-7161(96)13004-2_bib82","doi-asserted-by":"crossref","first-page":"411","DOI":"10.1093\/biomet\/72.2.411","article-title":"Analysis of incomplete data in a two-period crossover design with reference to clinical trials","volume":"72","author":"Patel","year":"1985","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib83","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1093\/biomet\/73.3.707","article-title":"Analysis of repeated measures designs with changing covariates in clinical trials","volume":"73","author":"Patel","year":"1986","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib84","series-title":"Statistical Issues in Pharmaceutical Development","first-page":"177","article-title":"Baseline measurements in a 2 \u00d7 2 crossover trial","author":"Patel","year":"1990"},{"key":"10.1016\/S0169-7161(96)13004-2_bib85","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1093\/biomet\/78.3.609","article-title":"Analysis of incomplete data from a clinical trial with repeated measurements","volume":"78","author":"Patel","year":"1991","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib86","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1080\/10543409208835027","article-title":"Sample size for a dose-response study","volume":"2","author":"Patel","year":"1992","journal-title":"J. Biopharm. Statist."},{"key":"10.1016\/S0169-7161(96)13004-2_bib87","doi-asserted-by":"crossref","first-page":"451","DOI":"10.1080\/03610929408831266","article-title":"Dose-response in pharmacokinetics","volume":"23","author":"Patel","year":"1994","journal-title":"Comm. Statist. Theory Methods"},{"key":"10.1016\/S0169-7161(96)13004-2_bib88","doi-asserted-by":"crossref","first-page":"981","DOI":"10.1080\/03610929408831299","article-title":"Group sequential analysis of a clinical trial with repeated measurements","volume":"23","author":"Patel","year":"1994","journal-title":"Comm. Statist. Theory Methods"},{"key":"10.1016\/S0169-7161(96)13004-2_bib89","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1016\/0378-3758(94)90200-3","article-title":"A repeated measures design with repeated randomization","volume":"42","author":"Patel","year":"1994","journal-title":"J. Statist. Plann. Inference"},{"key":"10.1016\/S0169-7161(96)13004-2_bib90","doi-asserted-by":"crossref","first-page":"471","DOI":"10.1002\/bimj.4710260502","article-title":"A problem of equivalence in clinical trials","volume":"5","author":"Patel","year":"1984","journal-title":"Biom. J."},{"key":"10.1016\/S0169-7161(96)13004-2_bib91","doi-asserted-by":"crossref","first-page":"2259","DOI":"10.1080\/03610928108828187","article-title":"Analysis of incomplete data in experiments with repeated measurements using a stochastic model","volume":"22","author":"Patel","year":"1981","journal-title":"Comm. Statist. Theory Methods"},{"key":"10.1016\/S0169-7161(96)13004-2_bib92","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1093\/biomet\/51.3-4.313","article-title":"A generalized multivariate analysis of variance model useful especially for growth curve problems","volume":"51","author":"Potthoff","year":"1964","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib93","doi-asserted-by":"crossref","first-page":"825","DOI":"10.2307\/2532642","article-title":"Estimating equations for parameters in means and covariances of multivariate discrete and continuous responses","volume":"47","author":"Prentice","year":"1991","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib94","doi-asserted-by":"crossref","first-page":"1525","DOI":"10.1002\/sim.4780131504","article-title":"Monte Carlo methods for exploring sensitivity to distributional assumptions in a Bayesian analysis of a series of 2 \u00d7 2 tables","volume":"13","author":"Raghunathan","year":"1994","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib95","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1093\/biomet\/80.1.127","article-title":"Analysis of binary data from a multicenter clinical trial","volume":"80","author":"Raghunathan","year":"1993","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib96","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1093\/biomet\/46.1-2.49","article-title":"Some problems involving linear hypotheses in multivariate analysis","volume":"46","author":"Rao","year":"1959","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib97","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1093\/biomet\/52.3-4.447","article-title":"A theory of least squares when the parameters are stochastic and its application to the analysis of growth curves","volume":"52","author":"Rao","year":"1965","journal-title":"Biometrika"},{"year":"1988","series-title":"Estimation of Variance Components and Applications","author":"Rao","key":"10.1016\/S0169-7161(96)13004-2_bib98"},{"key":"10.1016\/S0169-7161(96)13004-2_bib99","doi-asserted-by":"crossref","first-page":"1583","DOI":"10.1002\/sim.4780131509","article-title":"On closed test procedures for dose-response analysis","volume":"13","author":"Rom","year":"1994","journal-title":"Statist. Med."},{"year":"1980","series-title":"Clinical Pharmacokinetics: Concepts and Applications","author":"Rowland","key":"10.1016\/S0169-7161(96)13004-2_bib100"},{"key":"10.1016\/S0169-7161(96)13004-2_bib101","doi-asserted-by":"crossref","first-page":"581","DOI":"10.1093\/biomet\/63.3.581","article-title":"Inference and missing data","volume":"63","author":"Rubin","year":"1976","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib102","doi-asserted-by":"crossref","first-page":"1211","DOI":"10.1002\/sim.4780131204","article-title":"Analysis of longitudinal data: Random coefficient regression modelling","volume":"13","author":"Rutter","year":"1994","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib103","doi-asserted-by":"crossref","first-page":"719","DOI":"10.1093\/biomet\/78.4.719","article-title":"Estimation in generalized linear models with random effects","volume":"78","author":"Schall","year":"1991","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13004-2_bib104","doi-asserted-by":"crossref","first-page":"1109","DOI":"10.1002\/sim.4780121202","article-title":"On population and individual bioequivalence","volume":"12","author":"Schall","year":"1993","journal-title":"Statist. Med."},{"year":"1959","series-title":"The Analysis of Variance","author":"Scheff\u00e9","key":"10.1016\/S0169-7161(96)13004-2_bib105"},{"key":"10.1016\/S0169-7161(96)13004-2_bib106","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1080\/01621459.1986.10478258","article-title":"Confidence bounds for normal means under order restrictions, with application to dose-response curves, toxicological experiments, and low-dose extrapolation","volume":"81","author":"Schoenfeld","year":"1986","journal-title":"J. Amer. Statist. Assoc."},{"year":"1992","series-title":"Variance Components","author":"Searle","key":"10.1016\/S0169-7161(96)13004-2_bib107"},{"key":"10.1016\/S0169-7161(96)13004-2_bib108","series-title":"Biopharmaceutical Statistics for Drug Development","article-title":"Preclinical safety development","author":"Selwyn","year":"1988"},{"key":"10.1016\/S0169-7161(96)13004-2_bib109","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1007\/BF01061870","article-title":"Evaluation of methods for estimating population pharmacokinetic parameters. III. Nonexperimental model: Routine clinical pharmacokinetic data","volume":"11","author":"Sheiner","year":"1983","journal-title":"J. Pharmacokin. Biopharm."},{"key":"10.1016\/S0169-7161(96)13004-2_bib110","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1080\/10543409408835073","article-title":"Robust and bootstrap testing procedures for bioequivalence","volume":"4","author":"Shen","year":"1994","journal-title":"J. Biopharmaceut. Statist."},{"key":"10.1016\/S0169-7161(96)13004-2_bib111","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1002\/sim.4780080507","article-title":"The analysis of titration studies in Phase III clinical trials","volume":"8","author":"Shih","year":"1989","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib112","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1007\/BF01068419","article-title":"A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability","volume":"15","author":"Shuirmann","year":"1987","journal-title":"J. Pharmacokin. Biopharm."},{"key":"10.1016\/S0169-7161(96)13004-2_bib113","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1002\/sim.4780060603","article-title":"Evaluating the efficacy of a combination therapy","volume":"6","author":"Snapinn","year":"1987","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib114","doi-asserted-by":"crossref","first-page":"131","DOI":"10.2307\/2531249","article-title":"Multivariate bioassay, combination of bioassays, and Fieller's theorem","volume":"42","author":"Srivastava","year":"1986","journal-title":"Biometrics"},{"journal-title":"SAS Technical Report P-229. Software: Changes and Enhancements, Release 6.07","year":"1992","author":"SAS Institute Inc.","key":"10.1016\/S0169-7161(96)13004-2_bib115"},{"year":"1990","series-title":"SAS\/IML Software, Version 6","author":"SAS Institute Inc.","key":"10.1016\/S0169-7161(96)13004-2_bib116"},{"key":"10.1016\/S0169-7161(96)13004-2_bib117","doi-asserted-by":"crossref","first-page":"961","DOI":"10.2307\/2531147","article-title":"Random-effects model for several observations with binary response","volume":"40","author":"Stiratelli","year":"1984","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib118","doi-asserted-by":"crossref","first-page":"925","DOI":"10.2307\/2531693","article-title":"Design and analysis of Phase I clinical trials","volume":"45","author":"Storer","year":"1989","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib119","doi-asserted-by":"crossref","first-page":"1353","DOI":"10.1002\/sim.4780091112","article-title":"Design methods for some dose-response models","volume":"9","author":"Strijbosch","year":"1990","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13004-2_bib120","doi-asserted-by":"crossref","first-page":"95","DOI":"10.2307\/2531952","article-title":"A dose-response model incorporating nonlinear kinetics","volume":"43","author":"Van Ryzin","year":"1987","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib121","doi-asserted-by":"crossref","first-page":"1","DOI":"10.2307\/2532734","article-title":"Mixed-effects nonlinear regression for unbalanced repeated measures","volume":"48","author":"Vonesh","year":"1992","journal-title":"Biometrics"},{"year":"1971","series-title":"Biopharmaceutics and Relevant Pharmacokinetics","author":"Wagner","key":"10.1016\/S0169-7161(96)13004-2_bib122"},{"key":"10.1016\/S0169-7161(96)13004-2_bib123","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1002\/bimj.4710350105","article-title":"Basing the analysis of comparative bioavailability trials on an individualized statistical definition of equivalence","volume":"1","author":"Wellek","year":"1993","journal-title":"Biom. J."},{"key":"10.1016\/S0169-7161(96)13004-2_bib124","doi-asserted-by":"crossref","first-page":"1340","DOI":"10.1002\/jps.2600610845","article-title":"Use of confidence intervals in analysis of comparative bioavailability trials","volume":"61","author":"Westlake","year":"1972","journal-title":"J. Pharmac. Sci."},{"key":"10.1016\/S0169-7161(96)13004-2_bib125","doi-asserted-by":"crossref","first-page":"741","DOI":"10.2307\/2529259","article-title":"Symmetrical confidence intervals for bioequivalence trials","volume":"32","author":"Westlake","year":"1976","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib126","series-title":"Biopharmaceutical Statistics for Drug Development","first-page":"329","article-title":"Bioavailability and bioequivalence of pharmaceutical formulations","author":"Westlake","year":"1988"},{"key":"10.1016\/S0169-7161(96)13004-2_bib127","doi-asserted-by":"crossref","first-page":"519","DOI":"10.2307\/2556164","article-title":"The comparison of several dose levels with a zero dose control","volume":"28","author":"Williams","year":"1972","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib128","first-page":"351","article-title":"Experimental designs balanced for pairs of residual effects","volume":"3","author":"Williams","year":"1950","journal-title":"Austral. J. Sci. Res."},{"year":"1986","series-title":"Guidelines for the Investigation of Bioavailability","author":"WHO, Regional Office for Europe","key":"10.1016\/S0169-7161(96)13004-2_bib129"},{"key":"10.1016\/S0169-7161(96)13004-2_bib130","doi-asserted-by":"crossref","first-page":"939","DOI":"10.2307\/2531694","article-title":"Estimation and comparison of changes in the presence of informative right censoring: Conditional linear model","volume":"45","author":"Wu","year":"1989","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib131","doi-asserted-by":"crossref","first-page":"175","DOI":"10.2307\/2531905","article-title":"Estimation and comparison of changes in the presence of right censoring by modeling the censoring process","volume":"44","author":"Wu","year":"1988","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib132","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1080\/10543409308835048","article-title":"Analysis of multivariate parallel-line bioassay with composite responses and composite doses, using canonical correlations","volume":"3","author":"Yuan","year":"1993","journal-title":"J. Biopharm. Statist."},{"key":"10.1016\/S0169-7161(96)13004-2_bib133","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1080\/01621459.1991.10475006","article-title":"Generalized linear models with random effects: A Gibbs sampling approach","volume":"86","author":"Zeger","year":"1991","journal-title":"J. Amer. Statist. Assoc."},{"key":"10.1016\/S0169-7161(96)13004-2_bib134","doi-asserted-by":"crossref","first-page":"121","DOI":"10.2307\/2531248","article-title":"Longitudinal data analysis for discrete and continuous outcomes","volume":"42","author":"Zeger","year":"1986","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib135","doi-asserted-by":"crossref","first-page":"1049","DOI":"10.2307\/2531734","article-title":"Models for longitudinal data: A generalized estimating equation approach","volume":"44","author":"Zeger","year":"1988","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13004-2_bib136","doi-asserted-by":"crossref","first-page":"1019","DOI":"10.2307\/2531732","article-title":"Markov regression models for time series: A quasi-likelihood approach","volume":"44","author":"Zeger","year":"1988","journal-title":"Biometrics"}],"container-title":["Handbook of Statistics","Design and Analysis of Experiments"],"original-title":[],"language":"en","deposited":{"date-parts":[[2024,12,31]],"date-time":"2024-12-31T19:30:31Z","timestamp":1735673431000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0169716196130042"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[1996]]},"ISBN":["9780444820617"],"references-count":136,"URL":"https:\/\/doi.org\/10.1016\/s0169-7161(96)13004-2","relation":{},"ISSN":["0169-7161"],"issn-type":[{"type":"print","value":"0169-7161"}],"subject":[],"published":{"date-parts":[[1996]]}}}