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The top documents tagged [fdaindustry workshop]

Using an Independent Statistician to Support a Data Monitoring Committee Patrick D. OMeara, Ph.D. Pat OMeara Associates, Inc. pat@patomeara.com FDA/Industry
Using an Independent Statistician to Support a Data Monitoring Committee Patrick D. OMeara, Ph.D. Pat OMeara Associates, Inc. [email protected] FDA/Industry
216 views
Emerging Issues with Adaptation of Clinical Trial Design in Drug Development* H.M. James Hung Division of Biometrics I, Office of Biostatistics, OPaSS,
Emerging Issues with Adaptation of Clinical Trial Design in Drug Development* H.M. James Hung Division of Biometrics I, Office of Biostatistics, OPaSS,
216 views
Correcting for Selection Bias in Randomized Clinical Trials Vance W. Berger, NCI 9/15/05 FDA/Industry Workshop, DC
Correcting for Selection Bias in Randomized Clinical Trials Vance W. Berger, NCI 9/15/05 FDA/Industry Workshop, DC
216 views
A Regulatory Perspective on Design and Analysis of Combination Drug Trial* H.M. James Hung Division of Biometrics I, Office of Biostatistics OPaSS, CDER,
A Regulatory Perspective on Design and Analysis of Combination Drug Trial* H.M. James Hung Division of Biometrics I, Office of Biostatistics OPaSS, CDER,
218 views
FDA/Industry Workshop: Case Studies in M&S Copyright 2006, metrum research group LLC September 29, 2006 1 Exposure-Response (PK-PD) Applied to Model-Based
FDA/Industry Workshop: Case Studies in M&S Copyright 2006, metrum research group LLC September 29, 2006 1 Exposure-Response (PK-PD) Applied to Model-Based
215 views
1 Bayesian CTS example @ FDA/Industry Workshop September 18, 2003Copyright Pharsight Case Study in the Use of Bayesian Hierarchical Modeling and Simulation
1 Bayesian CTS example @ FDA/Industry Workshop September 18, 2003Copyright Pharsight Case Study in the Use of Bayesian Hierarchical Modeling and Simulation
214 views
James Hung, 2004 FDA/Industry Management of Missing Data in Clinical Trials from a Regulatory Perspective H.M. James Hung Div. of Biometrics I, OB/OPaSS/CDER/FDA
James Hung, 2004 FDA/Industry Management of Missing Data in Clinical Trials from a Regulatory Perspective H.M. James Hung Div. of Biometrics I, OB/OPaSS/CDER/FDA
218 views
FDA/Industry Workshop September, 19, 2003 Johnson & Johnson Pharmaceutical Research and Development L.L.C. 1 Uses and Abuses of (Adaptive) Randomization:
FDA/Industry Workshop September, 19, 2003 Johnson & Johnson Pharmaceutical Research and Development L.L.C. 1 Uses and Abuses of (Adaptive) Randomization:
216 views
FDA/Industry Workshop September 14-16, 2005 Critical Path Initiative: What it means for pharmaceutical industry statisticians Walter Offen, Lilly Brenda
FDA/Industry Workshop September 14-16, 2005 Critical Path Initiative: What it means for pharmaceutical industry statisticians Walter Offen, Lilly Brenda
224 views
Selection of Differential Expression Genes in Microarray Experiments James J. Chen, Ph.D. Division of Biometry and Risk Assessment National Center for
Selection of Differential Expression Genes in Microarray Experiments James J. Chen, Ph.D. Division of Biometry and Risk Assessment National Center for
216 views
Biomarkers and Surrogate Endpoints in Drug Development Technical and Regulatory Considerations Biomarkers and Surrogate Endpoints in Drug Development Technical
Biomarkers and Surrogate Endpoints in Drug Development Technical and Regulatory Considerations Biomarkers and Surrogate Endpoints in Drug Development Technical
223 views
An Introduction to PK/PD Models Part 2 Yaming Hang Biogen Sep. 16, 2015 FDA/Industry Workshop 2015 1
An Introduction to PK/PD Models Part 2 Yaming Hang Biogen Sep. 16, 2015 FDA/Industry Workshop 2015 1
230 views