The top documents tagged [fda draft guidance]

Appealing to users: developing usable & desirable devices
Documents Appealing to users: developing usable & desirable devices

836 views

Statistical Methods for Assessment of Individual/Population Bioequivalence Shein-Chung Chow, Ph.D. Biostatistics and Clinical Data Management Millennium
Documents Statistical Methods for Assessment of Individual/Population Bioequivalence Shein-Chung Chow, Ph.D. Biostatistics and Clinical Data Management Millennium

227 views

Introduction to Bayesian inference and computation for social science data analysis Nicky Best Imperial College, London
Documents Introduction to Bayesian inference and computation for social science data analysis Nicky Best Imperial College, London

246 views

Fda guidance for pharmaceutical post marketing reporting professor pirouzi
Health & Medicine Fda guidance for pharmaceutical post marketing reporting professor pirouzi

1.810 views

CIMT at Berlin DKG Meeting
Documents CIMT at Berlin DKG Meeting

471 views

FDA Guidance_Disclosing Risk_Generic
Documents FDA Guidance_Disclosing Risk_Generic

20 views

Joseph Levy MedicReS World Congress 2013 - 1
Health & Medicine Joseph Levy MedicReS World Congress 2013 - 1

398 views

1 FDA DRAFT GUIDANCE ON CLINICAL TRIAL DATA MONTORING COMMITTEES Susan S. Ellenberg, Ph.D. Office of Biostatistics and Epidemiology Center for Biologics
Documents 1 FDA DRAFT GUIDANCE ON CLINICAL TRIAL DATA MONTORING COMMITTEES Susan S. Ellenberg, Ph.D. Office of Biostatistics and Epidemiology Center for Biologics

219 views

Adaptive Designs for Clinical Trials Frank Bretz Novartis 24 April 2013, Tel Aviv
Documents Adaptive Designs for Clinical Trials Frank Bretz Novartis 24 April 2013, Tel Aviv

216 views

Exploration of Endpoints for Pivotal Clinical Trials to Treat AUD Raye Z. Litten, Ph.D. Daniel Falk, Ph.D. (Discussant) Division of Treatment and Recovery
Documents Exploration of Endpoints for Pivotal Clinical Trials to Treat AUD Raye Z. Litten, Ph.D. Daniel Falk, Ph.D. (Discussant) Division of Treatment and Recovery

214 views

Patient Reported Outcomes in Oncology Trials Virginia Kwitkowski Clinical Reviewer-- FDA Division of Drug Oncology Products Member OND Patient Reported
Documents Patient Reported Outcomes in Oncology Trials Virginia Kwitkowski Clinical Reviewer-- FDA Division of Drug Oncology Products Member OND Patient Reported

218 views

1 Research Study: The Participation of Pregnant Women in Clinical Research: Implications for Practice within the U.S. Pharmaceutical Industry University
Documents 1 Research Study: The Participation of Pregnant Women in Clinical Research: Implications for Practice within the U.S. Pharmaceutical Industry University

213 views