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Journal of Biopharmaceutical Statistics

Journal of Biopharmaceutical Statistics

中文名称：生物药物统计学杂志

ISSN：1054-3406
出版周期：4 times a year

发文量：290

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1.Seamless Phase IIa/IIb and enhanced dose-finding adaptive design

机译：Seamless Phase IIa/IIb and enhanced dose-finding adaptive design
- 作者：Yuan Jiacheng;Pang Herbert;Tong TiejunXi DongGuo WenzhaoMesenbrink Peter
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2016年第5期
- Adaptive design;
- dose finding;
- proof of concept;
- seamless design;
- utility;
2.STATISTICAL INFERENCE FOR THE WITHIN-DEVICEPRECISION OF QUANTITATIVE MEASUREMENTSIN ASSAY VALIDATION

机译：STATISTICAL INFERENCE FOR THE WITHIN-DEVICEPRECISION OF QUANTITATIVE MEASUREMENTSIN ASSAY VALIDATION
- 作者：Jen-pei Liu;Li-tien Lu;C. T. Liao
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第5期
- Expected length;
- Nested design;
- Probability coverage;
- Within-device precision;
3.Maximum Likelihood Estimation of Titer via a Power Family of Four-Parameter Logistic Model

机译：Maximum Likelihood Estimation of Titer via a Power Family of Four-Parameter Logistic Model
- 作者：Yang Hongmei;Holden-Wiltse Jeanne;Topham David J.Treanor John
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2018年第3期
- Exchangeable binary data;
- four-parameter logistic model;
- power family;
4.Statistical approaches for evaluating surrogate outcomes in clinical trials: A systematic review

机译：Statistical approaches for evaluating surrogate outcomes in clinical trials: A systematic review
- 作者：Ensor Hannah;Lee Robert J.;Sudlow CathieWeir Christopher J.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2016年第5期
- Clinical trials;
- statistical methodology;
- surrogate evaluation;
- systematic review;
5.Generalization of the time-to-event continual reassessment method to bivariate outcomes

机译：Generalization of the time-to-event continual reassessment method to bivariate outcomes
- 作者：Yan Donglin;Tait Christopher;Wages Nolan A.Kindwall-Keller TamilaDressler Emily V
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2019年第4期
- Time-to-event;
- continual reassessment method;
- dose finding;
- optimal dose;
- molecularly targeted agent;
6.A log-normal model for individual bioequivalence

机译：A log-normal model for individual bioequivalence
- 作者：Kem F. Phillips
- 期刊名称：《journal of biopharmaceutical statistics》 | 1993年第2期
- Hypothesis testing;
- Bioequivalence;
- TIER rule;
- 75#x2013;
- 75 rule;
7.Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect

机译：Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect
- 作者：Li Jing;Zhang Ying;Myer Laura J.Bravata Dawn M.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2019年第4期
- Stepped-wedge design;
- power analysis;
- cluster randomized trials;
- pragmatic clinical trials;
8.Considerations for pediatric trial designs and analyses

机译：Considerations for pediatric trial designs and analyses
- 作者：Cho Meehyung;Qiu Zhiying;Ye JennyQuan HuiZhao Peng-Liang
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2018年第3期
- Bayesian method;
- empirical shrinkage estimation;
- James-Stein shrinkage estimation;
- pediatric;
- sample size;
- weighted combination;
9.Likelihood ratio test-based method for signal detection in drug classes using FDA's AERS database

机译：Likelihood ratio test-based method for signal detection in drug classes using FDA's AERS database
- 作者：Huang L.;Zalkikar J.;Tiwari R.C.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第1期
- Drug class;
- Gadolinium drugs;
- Safety signals;
- Simplified Bayesian;
- Statin drugs;
- Weight matrix;
10.Multiple-time-point dissolution specifications for a sampling acceptance plan

机译：Multiple-time-point dissolution specifications for a sampling acceptance plan
- 作者：James J. Chen;Yi Tsong
- 期刊名称：《journal of biopharmaceutical statistics》 | 1997年第2期
11.On the Use of Historical Control Data in Pre-Clinical Safety Studies

机译：On the Use of Historical Control Data in Pre-Clinical Safety Studies
- 作者：J. T. Maringwa;C. Faes;M. AertsH. GeysG. TeunsB. Van Den PoelL. Bijnens
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2007年第3期
- Bias;
- Dose-trend;
- Empirical Bayes estimates;
- Examined study;
- Historical control studies;
- Logistic-normal model;
- Power;
- Precision;
12.Continual Reassessment Method vs. Traditional Empirically Based Design: Modifications Motivated by Phase I Trials in Pediatric Oncology by the Pediatric Brain Tumor Consortium

机译：Continual Reassessment Method vs. Traditional Empirically Based Design: Modifications Motivated by Phase I Trials in Pediatric Oncology by the Pediatric Brain Tumor Consortium
- 作者：Onar A;Kocak M;Boyett JM
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第3期
- Continual reassessment method;
- Dose finding;
- Dose-toxicity model;
- Simulation;
- Up-and- down studies;
13.DETERMINING CAUSAL EXPOSURE-RESPONSE RELATIONSHIPS WITH RANDOMIZED CONCENTRATION-CONTROLLED TRIALS

机译：DETERMINING CAUSAL EXPOSURE-RESPONSE RELATIONSHIPS WITH RANDOMIZED CONCENTRATION-CONTROLLED TRIALS
- 作者：Jixian Wang
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2014年第4期
- Confounding bias;
- Dose-exposure model;
- Exposure-response model;
- Instrumental variable;
- Randomized concentration control;
14.Assessment of bioequivalence using a multiplicative model

机译：Assessment of bioequivalence using a multiplicative model
- 作者：Shein-Chung Chow;Karl E. Peace;Jun Shao
- 期刊名称：《journal of biopharmaceutical statistics》 | 1991年第2期
- Individual subject ratios;
- Bioavailability;
- Bioequivalence;
- Multiplicative model;
15.Quantitative assessment of a prognostic or predictive biomarker panel

机译：Quantitative assessment of a prognostic or predictive biomarker panel
- 作者：Korn Edward L.;Freidlin Boris
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2018年第2期
- Chemoresistance assay;
- chemosensitivity assay;
- missing data;
- multivariate biomarker;
- predictive assay;
- PDX assay;
- prognostic assay;
16.Scientific Factors and Current Issues in Biosimilar Studies

机译：Scientific Factors and Current Issues in Biosimilar Studies
- 作者：Chow Shein-Chung;Endrenyi Laszlo;Lachenbruch Peter A.Mentre France
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2014年第6期
- Bioequivalence;
- Moment-based approach;
- Biosimilarity index;
- Totality of the evidence;
- Probability-based approach;
- Biosimilarity;
17.Crossover versus parallel designs: Dose-escalation design comparisons for first-in-human studies

机译：Crossover versus parallel designs: Dose-escalation design comparisons for first-in-human studies
- 作者：Yan Z.;Hosmane B.;Locke C.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第4期
- Baseline covariate;
- Crossover design;
- First-in-human study;
- Parallel design;
- Relative A-efficiency.;
18.A note on the small sample behavior of logistic regression in a bioassay setting

机译：A note on the small sample behavior of logistic regression in a bioassay setting
- 作者：Quinton J. Nottingham;Jeffrey B. Birch
- 期刊名称：《journal of biopharmaceutical statistics》 | 1998年第4期
- Maximum likelihood estimation;
- D-optimal design;
19.Testing a noninferiority hypothesis: What to anticipate when the adverse event is rare

机译：Testing a noninferiority hypothesis: What to anticipate when the adverse event is rare
- 作者：McEvoy B.W.;Frimpong E.Y.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第1期
- Approximations;
- Drug safety;
- Noninferiority;
- Rare events;
- Sample size;
20.MISSING INACTION: PREVENTING MISSING OUTCOME DATA IN RANDOMIZED CLINICAL TRIALS

机译：MISSING INACTION: PREVENTING MISSING OUTCOME DATA IN RANDOMIZED CLINICAL TRIALS
- 作者：Wittes J
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第6期
- Completers analysis;
- Imputation;
- Last observation carried forward;
- Missing data;
- Multiple imputation;
- Randomized clinical trials;
21.STATISTICAL METHODS FOR ACTIVE PHARMACOVIGILANCE, WITH APPLICATIONS TO DIABETES DRUGS

机译：STATISTICAL METHODS FOR ACTIVE PHARMACOVIGILANCE, WITH APPLICATIONS TO DIABETES DRUGS
- 作者：Lan Zhuo;Patrick J. Farrell;Doug McNairDaniel Krewski
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2014年第4期
22.Combining risk difference and risk ratio in noninferiority trials of safety

机译：Combining risk difference and risk ratio in noninferiority trials of safety
- 作者：Broglio K.R.;Connor J.T.;Berry S.M.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第1期
- Noninferiority;
- Premarket;
- Risk difference;
- Risk ratio;
- Safety;
23.A nested group sequential framework for regional evaluation in global drug development program

机译：A nested group sequential framework for regional evaluation in global drug development program
- 作者：Wang William;Jiang Zhiwei;Qiu JingjunXia JielaiGuo Xiang
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2017年第6期
- Discounting factor;
- global drug development;
- MRCT;
- nested group sequential design;
- sample size estimation;
- virtual trial;
24.Optimal Estimation for Regression Models on tau-Year Survival Probability

机译：Optimal Estimation for Regression Models on tau-Year Survival Probability
- 作者：Kwak Minjung;Kim Jinseog;Jung Sin-Ho
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2015年第3期
- Logistic regression;
- Survival probability;
- Censoring distribution;
- Non-negative definite;
25.A modified Wald test for reference scaled assessment of analytical equivalence

机译：A modified Wald test for reference scaled assessment of analytical equivalence
- 作者：Weng Yu-Ting;Tsong Yi;Shen MeiyuWang Chao
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2019年第6期
- Equivalence tests;
- Wald tests;
- constrained maximum likelihood estimate;
- exact-based test;
- GPQ;
- analytical equivalence;
26.AN URN MODEL FOR ODDS-RATIO-BASEDRESPONSE-ADAPTIVE PHASE III CLINICAL TRIALSFOR TWO OR MORE TREATMENTS

机译：AN URN MODEL FOR ODDS-RATIO-BASEDRESPONSE-ADAPTIVE PHASE III CLINICAL TRIALSFOR TWO OR MORE TREATMENTS
- 作者：Gopal K. Basak;Atanu Biswas;Stanislav Volkov
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第5期
- Adaptive designs;
- Limiting allocation probability;
- Odds ratio estimates;
- Play-the-winnerrule;
- Treatment effect mapping;
27.Avoiding ambiguity with the Type I error rate in noninferiority trials

机译：Avoiding ambiguity with the Type I error rate in noninferiority trials
- 作者：Kang Seung-Ho
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2016年第3期
- Across-trial power;
- across-trial Type I error rate;
- biosimilar;
- within-trial power;
- within-trial Type I error rate;
28.Test non-inferiority and sample size determination based on the odds ratio under a cluster randomized trial with noncompliance

机译：Test non-inferiority and sample size determination based on the odds ratio under a cluster randomized trial with noncompliance
- 作者：Lui K.-J.;Chang K.-C.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2011年第1期
- Cluster sampling;
- Dirichlet-multinomial model;
- Intraclass correlation;
- Non-inferiority;
- Noncompliance;
- Odds ratio;
29.Profile Likelihood-Based Confidence Intervals Using Monte Carlo Integration for Population Pharmacokinetic Parameters

机译：Profile Likelihood-Based Confidence Intervals Using Monte Carlo Integration for Population Pharmacokinetic Parameters
- 作者：Takashi Funatogawa;Ikuko Funatogawa;Akifumi Yafune
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2006年第2期
30.Assessing the prediction accuracy of a cure model for censored survival data with long-term survivors: Application to breast cancer data

机译：Assessing the prediction accuracy of a cure model for censored survival data with long-term survivors: Application to breast cancer data
- 作者：Asano Junichi;Hirakawa Akihiro
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2017年第6期
31.Clinical Development and Trial Design of Biosimilar Products: A Japanese Perspective

机译：Clinical Development and Trial Design of Biosimilar Products: A Japanese Perspective
- 作者：Nagasaki Masayuki;Ando Yuki
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2014年第6期
- Biosimilarity;
- Equivalence margin;
- Global clinical trial;
32.MISSING DATA HANDLING METHODS IN MEDICAL DEVICE CLINICAL TRIALS

机译：MISSING DATA HANDLING METHODS IN MEDICAL DEVICE CLINICAL TRIALS
- 作者：Yan X;Lee S;Li N
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第6期
- Clinical trials;
- Dropout;
- Imputation methods;
- Missing data;
- Missing;
- data mechanism;
- Tipping-point analysis;
33.PERMUTATION TEST FOLLOWING COVARIATE-ADAPTIVE RANDOMIZATION IN RANDOMIZED CONTROLLED TRIALS

机译：PERMUTATION TEST FOLLOWING COVARIATE-ADAPTIVE RANDOMIZATION IN RANDOMIZED CONTROLLED TRIALS
- 作者：Takahiro Hasegawa;Toshiro Tango
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第1期
- Covaiiate-adaptive randomization;
- Invoked population model;
- Linear models;
- Monte Carlo method;
- Peimutation tests;
- Randomization model;
34.A Statistical Approach to Determining Criticality of Residual Host Cell DNA

机译：A Statistical Approach to Determining Criticality of Residual Host Cell DNA
- 作者：Yang Harry;Wei Ziping;Schenerman Mark
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2015年第2期
- Residual host cell DNA;
- Quality by design;
- Infectivity;
- Critical quality attribute;
- Oncogenicity;
- Risk assessment;
35.COMPARISON OF BRACKETING AND MATRIXING DESIGNS FOR A TWO-YEAR STABILITY STUDY

机译：COMPARISON OF BRACKETING AND MATRIXING DESIGNS FOR A TWO-YEAR STABILITY STUDY
- 作者：Annpey Pong;Damaraju Raghavarao
- 期刊名称：《journal of biopharmaceutical statistics》 | 2000年第2期
- Stability study;
- Bracketing design;
- Matrixing design;
- Shelf life;
- Degradation;
- Expiration dating period;
36.ROBUSTNESS OF THE QUARTILES OF SURVIVAL TIME AND SURVIVAL PROBABILITY

机译：ROBUSTNESS OF THE QUARTILES OF SURVIVAL TIME AND SURVIVAL PROBABILITY
- 作者：Parichehr Hemyari
- 期刊名称：《journal of biopharmaceutical statistics》 | 2000年第3期
- Simulation experiment;
- Weibull distribution;
- Robustness;
- Median;
- Survival time;
37.Evaluation of early efficacy endpoints for proof-of-concept trials

机译：Evaluation of early efficacy endpoints for proof-of-concept trials
- 作者：Chen C.;Sun L.;Li C.-L.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第2期
- Benefit-cost ratio;
- Decision analysis;
- Expected power;
- Oncology;
38.Weighted rank tests for noninferiority hypotheses based on paired survival times

机译：Weighted rank tests for noninferiority hypotheses based on paired survival times
- 作者：Jin H.;Zhao N.;Tu D.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第2期
- Noninferiority;
- Paired survival times;
- Rank test;
- Sample size;
39.Optimal Design for Dose Response Using Beta Distributed Responses

机译：Optimal Design for Dose Response Using Beta Distributed Responses
- 作者：Yuehui Wu;Valerii V. Fedorov;Kathleen J. Propert
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2005年第5期
- Beta regression;
- Locally optimal design;
- Robustness;
- Sensitivity function;
40.Innovative Approaches in Drug Development

机译：Innovative Approaches in Drug Development
- 作者：Mark Chang;Susan Kenley;Jonca BullYuan-Yuan ChiuWenjin WangCharles WakefordKatherine McCarthy
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2007年第5期
- Adaptive design;
- Biomarker;
- Bayesian;
- Group sequential design;
- Trial simulation;
41.Assessing Individual Agreement

机译：Assessing Individual Agreement
- 作者：Huiman X. Barnhart;Andrzej S. Kosinski;Michael J. Haber
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2007年第4期
42.Multistage Designs for Vaccine Safety Studies

机译：Multistage Designs for Vaccine Safety Studies
- 作者：V. Dragalin;V. Fedorov
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2006年第4期
43.Design of experiment for nonlinear dynamic gene regulatory network identification

机译：Design of experiment for nonlinear dynamic gene regulatory network identification
- 作者：Lu Tao
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2018年第3期
- Adaptive group LASSO;
- experiment design;
- mixed-effects models;
- time-course microarray data;
- variable selection;
44.Two-stage designs for the logistic regression model in single-agent bioassays

机译：Two-stage designs for the logistic regression model in single-agent bioassays
- 作者：William R. Myers;Raymond H. Myers;Walter H. CarterKimber L. White
- 期刊名称：《journal of biopharmaceutical statistics》 | 1996年第3期
- Logistic regression;
- Design optimality;
- Two-stage design;
- Integrated variance;
45.Statistical Considerations for Testing Multiple Endpoints in Group Sequential or Adaptive Clinical Trials

机译：Statistical Considerations for Testing Multiple Endpoints in Group Sequential or Adaptive Clinical Trials
- 作者：H. M. James Hung;Sue-Jane Wang;Robert ONeillp
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2007年第6期
- Adaptive design;
- Closed testing;
- Flexible design;
- Group sequential;
- Primary endpoint;
- Secondary endpoint;
46.Baseline balance and conditional size: a reply to overall Et al

机译：Baseline balance and conditional size: a reply to overall Et al
- 作者：Stephen Senn
- 期刊名称：《journal of biopharmaceutical statistics》 | 1996年第2期
47.Significance Analysis of ROC Indices for Comparing Diagnostic Markers: Applications to Gene Microarray Data

机译：Significance Analysis of ROC Indices for Comparing Diagnostic Markers: Applications to Gene Microarray Data
- 作者：Chen-An Tsai;James J. Chen
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2004年第4期
48.Using aspects of study design in sample size estimation

机译：Using aspects of study design in sample size estimation
- 作者：Alan Phillips;Mike Campbell
- 期刊名称：《journal of biopharmaceutical statistics》 | 1997年第2期
- Sample size;
- Repeated measures;
- Ordered categorical data;
- Equivalence;
49.Step-down trend tests for identifying the minimum effective dose

机译：Step-down trend tests for identifying the minimum effective dose
- 作者：Dhammika Amaratunga;Nanxiang Ge
- 期刊名称：《journal of biopharmaceutical statistics》 | 1998年第1期
- Minimum effective dose;
- Stepwise testing procedure;
- Bartholomew's trend test;
- Welch's trend test;
- Linear contrast test;
- M-power;
50.Detection and prediction limits for identifying highly confusable drug names from experimental data

机译：Detection and prediction limits for identifying highly confusable drug names from experimental data
- 作者：Lambert Bruce L.;Bhaumik Runa;Zhao WeihanBhaumik Dulal K.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2016年第2期
- Detection limits;
- drug name confusion;
- medication errors;
- patient safety;
- poisson prediction limits;
51.General estimation of relative potency using prior information

机译：General estimation of relative potency using prior information
- 作者：P. T. Kim;G. W. Cho;E. M. CarterJ. J. Hubert
- 期刊名称：《journal of biopharmaceutical statistics》 | 1992年第2期
- Asymmetry;
- Parallel line bioassay;
- Prior information;
- Posterior distribution;
- Relative potency;
52.Challenges in DNA Microarray Studies from the Regulatory Perspective

机译：Challenges in DNA Microarray Studies from the Regulatory Perspective
- 作者：Samir Lababidi
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2008年第1期
- Classifiers;
- Microarrays;
- Normalization;
- Prediction accuracy;
- Reproducibility;
53.PROBLEMATIC FORMULATIONS OF SAS PROC.MIXED MODELS FOR REPEATED MEASUREMENTS

机译：PROBLEMATIC FORMULATIONS OF SAS PROC.MIXED MODELS FOR REPEATED MEASUREMENTS
- 作者：JohnE. Overall;Chul Ahn;C. ShivakumarYallapa Kalburgi
- 期刊名称：《journal of biopharmaceutical statistics》 | 1999年第1期
- Mixed models;
- Repeated measures;
- Regression on time;
- Missing data;
- Test size;
- Covariates;
54.IMPROVING PROBABILITIES OF CORRECT INTERIM DECISION IN POPULATION ENRICHMENT DESIGNS

机译：IMPROVING PROBABILITIES OF CORRECT INTERIM DECISION IN POPULATION ENRICHMENT DESIGNS
- 作者：Goette Heiko;Donica Margarita;Mordenti Giacomo
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2015年第5期
- Adaptive design;
- Decision rule;
- Subpopulation;
55.Diagnostics for the multivariate linear model analysis of 2 x 2 crossover designs

机译：Diagnostics for the multivariate linear model analysis of 2 x 2 crossover designs
- 作者：Xuemin Xie;William D. Johnson
- 期刊名称：《journal of biopharmaceutical statistics》 | 1994年第3期
56.Editorial board

机译：Editorial board
- 期刊名称：《journal of biopharmaceutical statistics》 | 1996年第1期
57.Determining equivalence and the impact of sample size in anti-infective studies: a point to consider

机译：Determining equivalence and the impact of sample size in anti-infective studies: a point to consider
- 作者：David R. Bristol
- 期刊名称：《journal of biopharmaceutical statistics》 | 1996年第3期
- Equivalence;
- Binomial;
- Sample size;
- Anti-infectives;
58.A comparison of the random-effects pattern mixture model with last-observation-carried-forward(locf) analysis in longitudinal clinical trials with dropouts

机译：A comparison of the random-effects pattern mixture model with last-observation-carried-forward(locf) analysis in longitudinal clinical trials with dropouts
- 作者：Ohidul Siddiqui;Mirza W. Ali
- 期刊名称：《journal of biopharmaceutical statistics》 | 1998年第4期
- Monotone missing data;
- LOCF;
- Random effects;
- Pattern mixture model;
59.Rejoinder to the letter to the editor

机译：Rejoinder to the letter to the editor
- 作者：Bland J. Martin
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2019年第3期
60.Joint bent-cable Tobit models for longitudinal and time-to-event data

机译：Joint bent-cable Tobit models for longitudinal and time-to-event data
- 作者：Dagne Getachew A.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2018年第3期
- Accelerated failure time model;
- Bayesian inference;
- piecewise model;
- skew distribution;
- survival analysis;
61.Sample size determination for fold-increase endpoints defined by paired interval-censored data

机译：Sample size determination for fold-increase endpoints defined by paired interval-censored data
- 作者：Xu Ying;Lam K. F.;Cheung Yin Bun
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2016年第5期
- Dichotomization;
- distributional approach;
- fold-increase;
- paired interval-censored data;
- sample size estimation;
- standard titer;
62.Concurrent Generation of Ordinal and Normal Data

机译：Concurrent Generation of Ordinal and Normal Data
- 作者：Demirtas Hakan;Yavuz Yasemin
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2015年第4期
- Polyserial correlation;
- Point-polyserial correlation;
- Simulation;
- Polychoric correlation;
- Random number generation;
- Phi coefficient;
63.Multiple-objective optimal designs

机译：Multiple-objective optimal designs
- 作者：Yu-Chung Huang;Weng-Kee Wong
- 期刊名称：《journal of biopharmaceutical statistics》 | 1998年第4期
- Approximate design;
- D-optimality;
- Dose-response models;
- information matrix;
- Locally optimal design;
64.A CASE STUDY OF MODELING AND EXPOSURE-RESPONSE PREDICTION FOR COUNT DATA

机译：A CASE STUDY OF MODELING AND EXPOSURE-RESPONSE PREDICTION FOR COUNT DATA
- 作者：Hui Quan;Xuezhou Mao;LynnWeiLinWang
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2014年第5期
- Annualized relapse rate;
- Negative binomial;
- Plasma concentration;
- Recurrent event;
- Risk ratio;
- Trial simulation;
65.The practice of pre-marketing safety assessment in drug development (Review)

机译：The practice of pre-marketing safety assessment in drug development (Review)
- 作者：Chuang-Stein C.;Xia H.A.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第1期
66.Assessment of Relative Improvement Due to Weights Within Generalized Estimating Equations Framework for Incomplete Clinical Trials Data

机译：Assessment of Relative Improvement Due to Weights Within Generalized Estimating Equations Framework for Incomplete Clinical Trials Data
- 作者：Hakan Demirtas
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2004年第4期
- Nonignorable nonresponse;
- Estimating equations;
- Dropout;
- Longitudinal data;
67.A BIAS CORRECTION IN TESTING TREATMENT EFFICACY UNDER INFORMATIVE DROPOUT IN CLINICAL TRIALS

机译：A BIAS CORRECTION IN TESTING TREATMENT EFFICACY UNDER INFORMATIVE DROPOUT IN CLINICAL TRIALS
- 作者：Kong FH;Chen YF;Jin K
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第6期
- Grouping method;
- Linear mixed effects model;
- LOCF;
- MMRM;
- Non-ignorable;
- (informative) dropout;
- Treatment efficacy;
68.DISCUSSION OF 'SOME CONTROVERSIAL MULTIPLE TESTING PROBLEMS IN REGULATORY APPLICATIONS'

机译：DISCUSSION OF "SOME CONTROVERSIAL MULTIPLE TESTING PROBLEMS IN REGULATORY APPLICATIONS"
- 作者：Christy Chuang-Stein;Alex Dmitrienko;Walter Off en
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第1期
69.Studying treatment-effect heterogeneity in precision medicine through induced subgroups

机译：Studying treatment-effect heterogeneity in precision medicine through induced subgroups
- 作者：Sies Aniek;Demyttenaere Koen;Van Mechelen Iven
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2019年第3期
70.Utility analysis and calibration of QOL assessment in disease management

机译：Utility analysis and calibration of QOL assessment in disease management
- 作者：Liu Mo
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2018年第5期
- Calibration;
- disease management;
- patient-reported outcome;
- quality of life;
- utility analysis;
71.A METHOD FOR ESTIMATING AND TESTING AREA UNDER THE CURVE IN SERIAL SACRIFICE, BATCH, AND COMPLETE DATA DESIGNS

机译：A METHOD FOR ESTIMATING AND TESTING AREA UNDER THE CURVE IN SERIAL SACRIFICE, BATCH, AND COMPLETE DATA DESIGNS
- 作者：DanielJ. Holder;Francis Hsuan;Rakesh DixitKeith Soper
- 期刊名称：《journal of biopharmaceutical statistics》 | 1999年第3期
- AUC;
- Serial sacrifice;
- Toxicokinetics;
- Dose trend;
- Dose proportionality;
72.Statistical efficiency in multiple-to-one comparison trials with optimal allocation ratio

机译：Statistical efficiency in multiple-to-one comparison trials with optimal allocation ratio
- 作者：Zhang J.;Zhang J.J.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2011年第1期
- Multiple-to-one comparison;
- Multivalent vaccine;
- Optimal allocation ratio;
- Unequal variance;
73.The analysis of a multiple-dose, combination-drug clinical trial using response surface methodology

机译：The analysis of a multiple-dose, combination-drug clinical trial using response surface methodology
- 作者：James A. Phillips;Victoria Cairns;Gary G. Koch
- 期刊名称：《journal of biopharmaceutical statistics》 | 1992年第1期
- Combination drugs;
- Multiple doses;
- ANOVA;
- Multiple comparisons;
- Min test;
- Response surface methodology;
74.ON THE TIMING OF A FUTILITY ANALYSIS IN CLINICAL TRIALS

机译：ON THE TIMING OF A FUTILITY ANALYSIS IN CLINICAL TRIALS
- 作者：Allan Pallay
- 期刊名称：《journal of biopharmaceutical statistics》 | 2000年第3期
- Futility analysis;
- Predictive probability of significance;
- Clinical trials;
75.Poly-k-Trend Tests for Survival Adjusted Analysis of Tumor Rates Formulated as Approximate Multiple Contrast Test

机译：Poly-k-Trend Tests for Survival Adjusted Analysis of Tumor Rates Formulated as Approximate Multiple Contrast Test
- 作者：Frank Schaarschmidt;Martin Sill;Ludwig A. Hothorn
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2008年第5期
- Animal carcinogenicity study;
- Cochran-Armitage trend test;
- Multiple contrast test;
- Poly-3 test;
76.Commentary on “Accounting for the Interim Safety Monitoring of an Adverse Event Upon Termination of a Clinical Trial”

机译：Commentary on “Accounting for the Interim Safety Monitoring of an Adverse Event Upon Termination of a Clinical Trial”
- 作者：Jen-pei Liu
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2008年第4期
77.Estimation strategies for reacting to the identification of an association between the genome and adverse drug reactions

机译：Estimation strategies for reacting to the identification of an association between the genome and adverse drug reactions
- 作者：Thygesen H.;Su T.-L.;Whitehead J.Bowman C.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2011年第1期
- Adverse drug reaction;
- Exclusion rule;
- LASSO;
- Pharmacogenetics;
- Stratified medicine;
78.Multiple Polyexponentials and Quasipolynomials as Empirical Nonlinear Regression Models: A Case Study with HIV Viral Load Data

机译：Multiple Polyexponentials and Quasipolynomials as Empirical Nonlinear Regression Models: A Case Study with HIV Viral Load Data
- 作者：L. W. Huson;J. Chung;M. Salgo
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2006年第2期
- HIV1;
- Nonlinear regression;
- Polyexponential;
- Quasipolynomial;
79.A ROBUST SUMMARIZE#x2013;REGRESS PROCEDURE FOR TISSUE-SPECIFIC PHARMACOKINETICS

机译：A ROBUST SUMMARIZE#x2013;REGRESS PROCEDURE FOR TISSUE-SPECIFIC PHARMACOKINETICS
- 作者：MatthewS. Mayo;DonaldJ. Buchsbaum
- 期刊名称：《journal of biopharmaceutical statistics》 | 2000年第2期
- Compartmental models;
- Destructive sampling;
- Simulation;
- Radiolabeled ligands;
80.Comparison of treatments in a combination therapy trial

机译：Comparison of treatments in a combination therapy trial
- 作者：H. I. Patel
- 期刊名称：《journal of biopharmaceutical statistics》 | 1991年第2期
- Restricted null hypothesis;
- Noncentral bivariatet;
- Confidence interval;
- Optimal allocation;
81.Randomization-based analysis of covariance for inference in the sequential parallel comparison design

机译：Randomization-based analysis of covariance for inference in the sequential parallel comparison design
- 作者：Wiener Laura E.;Ivanova Anastasia;Li SiyingSilverman Rachel K.Koch Gary G.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2019年第4期
82.Demonstration of the reproducibility of treatment efficacy from a single multicenter trial

机译：Demonstration of the reproducibility of treatment efficacy from a single multicenter trial
- 作者：William J. Huster;William C. Louv
- 期刊名称：《journal of biopharmaceutical statistics》 | 1992年第2期
- Reproducibility;
- Clinical trials;
- Multicenter;
- Simulation;
- Bootstrapping;
83.A method for determining schedule dependency in tissue culture

机译：A method for determining schedule dependency in tissue culture
- 作者：Galen L. Wampler;Walter H. Carter;Eleanor D. CampbellPeggy A. Keefe
- 期刊名称：《journal of biopharmaceutical statistics》 | 1991年第2期
- Response surface;
- Schedule dependency;
- Cell culture;
- Etoposide;
- Cisplatin;
84.ESTIMATION OF MULTIPLE RESPONSE RATESIN PHASE II CLINICAL TRIALS WITH MISSINGOBSERVATIONS

机译：ESTIMATION OF MULTIPLE RESPONSE RATESIN PHASE II CLINICAL TRIALS WITH MISSINGOBSERVATIONS
- 作者：Myron Chang
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第5期
85.NONLINEAR CALIBRATION MODEL CHOICE BETWEEN THE FOUR AND FIVE-PARAMETER LOGISTIC MODELS

机译：NONLINEAR CALIBRATION MODEL CHOICE BETWEEN THE FOUR AND FIVE-PARAMETER LOGISTIC MODELS
- 作者：Cumberland William N.;Fong Youyi;Yu XuesongDefawe OlivierFrahm NicoleDe Rosa Stephen
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2015年第5期
- Bias-variance trade-off;
- Luminex;
- Nonlinear calibration;
- 5PL;
- 4PL;
86.Medical records-based postmarketing safety evaluation of rare events with uncertain status

机译：Medical records-based postmarketing safety evaluation of rare events with uncertain status
- 作者：Cao H.;Lavange L.M.;Heyse J.F.Mast T.C.Kosorok M.R.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第1期
- Logrank statistic;
- Poisson process;
- Postmarketing safety;
- Rare events;
87.Pharmacodynamic models: Parameterizing the hill equation, michaelis-menten, the logistic curve, and relationships among these models

机译：Pharmacodynamic models: Parameterizing the hill equation, michaelis-menten, the logistic curve, and relationships among these models
- 作者：Reeve R.;Turner J.R.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第3期
- Curvature;
- Hill model;
- Logistic model;
- Michaelis-Menten model;
- Multicollinearity;
- Nonlinear regression;
- Optimal parameterization;
88.A New Paradigm for Deriving and Analyzing Number Needed to Treat

机译：A New Paradigm for Deriving and Analyzing Number Needed to Treat
- 作者：Demissie Alemayehu;Ed Whalen
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2006年第2期
- Clinical benefit;
- Comparison of proportions;
- NNH;
- NNT;
- Random walks;
- Stopping time;
89.On assessment of bioequivalence under a higher-order crossover design

机译：On assessment of bioequivalence under a higher-order crossover design
- 作者：Shein-Chung Chow;Jen-Pei Liu
- 期刊名称：《journal of biopharmaceutical statistics》 | 1992年第2期
- Bioequivalence;
- Higher-order crossover design;
- Confidence interval;
- Interval hypotheses;
- Two one-sided tests;
90.Practical Bayesian Design and Analysis for Drug and Device Clinical Trials

机译：Practical Bayesian Design and Analysis for Drug and Device Clinical Trials
- 作者：Brian P. Hobbs;Bradley P. Carlin
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2008年第1期
- BRugs software;
- Historical controls;
- Interim monitoring;
- Markov chain Monte Carlo (MCMC);
- Sample size calculations;
- WinBUGS software;
91.Equivalence Assessment for Interchangeability Based on Two-Sided Tests

机译：Equivalence Assessment for Interchangeability Based on Two-Sided Tests
- 作者：Dong Xiaoyu;Tsong Yi
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2014年第6期
- Two-sided tolerance interval;
- Power;
- Type I error rate;
- Interchangeability;
- Sample size;
92.Confidence intervals versus #x3C1;-values for interpretation of clinical trial results: introduction

机译：Confidence intervals versus #x3C1;-values for interpretation of clinical trial results: introduction
- 作者：Gordon W. Pledger
- 期刊名称：《journal of biopharmaceutical statistics》 | 1993年第2期
- Estimation;
- Statistical test;
- Drug development;
93.Generalized ridge analysis with application to population pharmacokinetics/dynamics

机译：Generalized ridge analysis with application to population pharmacokinetics/dynamics
- 作者：James M. Minor;Hamid Namini;George A. Watson
- 期刊名称：《journal of biopharmaceutical statistics》 | 1996年第1期
- Population;
- Pharmacokinetics;
- Pharmacodynamics;
- Biotechnology;
- Ridge analysis;
- Neural networks;
94.Evolution of the canda at roche

机译：Evolution of the canda at roche
- 作者：Olga Rutman;Samuel V. Givens
- 期刊名称：《journal of biopharmaceutical statistics》 | 1997年第4期
95.A Tolerance Interval Approach for Assessment of Agreement with Left Censored Data

机译：A Tolerance Interval Approach for Assessment of Agreement with Left Censored Data
- 作者：Pankaj K. Choudhary
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2007年第4期
- Concordance correlation;
- Left censoring;
- Limit of detection;
- Limits of agreement;
- Method comparison;
- Mixed model;
- Total deviation index;
96.A DECISION ALGORITHM FOR TRANSLATING PRECLINICAL TRIAL RESULTS TO ENHANCE RECOVERY AFTER STROKE

机译：A DECISION ALGORITHM FOR TRANSLATING PRECLINICAL TRIAL RESULTS TO ENHANCE RECOVERY AFTER STROKE
- 作者：Jonathan D. Mahnken;Matthew S. Mayo;Randolph J. Nudo
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第1期
- Cooperative agreement;
- Milestones;
- Translational research;
- Type I error;
97.Optimal Two-Stage Randomized Multinomial Designs for Phase II Oncology Trials

机译：Optimal Two-Stage Randomized Multinomial Designs for Phase II Oncology Trials
- 作者：Sun LZ;Chen C;Patel K
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2009年第3期
- Multinomial;
- Oncology trials;
- Progression;
- Randomized;
- Response;
98.One-sample proportion testing procedures for hypothesis of inequality

机译：One-sample proportion testing procedures for hypothesis of inequality
- 作者：Zhong W.;Zhong B.
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2013年第3期
- Exact binomial distribution;
- Hypothesis of inequality;
- Minimized two-stage design;
- Phase 2 clinical trial;
- Single arm;
99.Dual composite reference standards (dCRS) in molecular diagnostic research: A new approach to reduce bias in the presence of Imperfect reference

机译：Dual composite reference standards (dCRS) in molecular diagnostic research: A new approach to reduce bias in the presence of Imperfect reference
- 作者：Tang Shaowu;Hemyari Parichehr;Canchola Jesse A.Duncan John
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2018年第5期
- Composite reference standard;
- discrepant analysis;
- latent class analysis;
- sensitivity;
- specificity;
100.An Overview on Assessing Agreement with Continuous Measurements

机译：An Overview on Assessing Agreement with Continuous Measurements
- 作者：Huiman X. Barnhart;Michael J. Haber;Lawrence I. Lin
- 期刊名称：《Journal of biopharmaceutical statistics》 | 2007年第4期

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