Search results: Sage Journals

Restricted accessOtherFirst published April, 1994

Japanese Perspectives on Harmonization Initiatives: Problems in Assessing Predrug Approval Clinical Safety Data

Chikayuki Naito

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 1995

Clinical Safety,Administration and Data Systems: How Should They be Integrated?

Steve Jolley

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published November, 2016

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

Patrick M. Schnell, Greg Ball

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 2003

Hepatotoxicity in the Review of Clinical Safety Data

Yeong-Liang Lin, Herng-Der Chern, Mong-Ling Chu

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published January, 2000

Evaluation of Safety Data from Controlled Clinical Trials: The Clinical Principles Explained

John E. Gait, Sandy Smith, Sherri L. Brown

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published January, 2002

Analysis of Drug Safety Data from Clinical Trials

Andrzej Czarnecki, Katarzyna Zalewska

Therapeutic Innovation & Regulatory Science

Free accessResearch articleFirst published May, 1992

Interpreting Clinical Laboratory Data in Safety Assessment Studies

Michael C. Carakostas

Toxicologic Pathology

Restricted accessResearch articleFirst published June, 2006

Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees

SCT Working Group on Data Monitoring, Dennis O Dixon, Ralph S Freedman [...]

Clinical Trials

Restricted accessResearch articleFirst published June, 2021

Institutionally Chartered Data and Safety Monitoring Boards: Structured Approaches to Assuring Participant Safety in Clinical Research

Blair Holbein, Marie T Rape, Barbara N Hammack [...]

Journal of Investigative Medicine

Restricted accessResearch articleFirst published June, 2004

Use of the false discovery rate for evaluating clinical safety data

Devan V Mehrotra, Joseph F Heyse

Statistical Methods in Medical Research

Restricted accessOtherFirst published April, 1994

Japanese Perspectives on Harmonization Initiatives: Problems in Assessing Predrug Approval Clinical Safety Data

Chikayuki Naito

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 1995

Clinical Safety,Administration and Data Systems: How Should They be Integrated?

Steve Jolley

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published November, 2016

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

Patrick M. Schnell, Greg Ball

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 2003

Hepatotoxicity in the Review of Clinical Safety Data

Yeong-Liang Lin, Herng-Der Chern, Mong-Ling Chu

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published January, 2000

Evaluation of Safety Data from Controlled Clinical Trials: The Clinical Principles Explained

John E. Gait, Sandy Smith, Sherri L. Brown

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published January, 2002

Analysis of Drug Safety Data from Clinical Trials

Andrzej Czarnecki, Katarzyna Zalewska

Therapeutic Innovation & Regulatory Science

Free accessResearch articleFirst published May, 1992

Interpreting Clinical Laboratory Data in Safety Assessment Studies

Michael C. Carakostas

Toxicologic Pathology

Restricted accessResearch articleFirst published June, 2006

Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees

SCT Working Group on Data Monitoring, Dennis O Dixon, Ralph S Freedman [...]

Clinical Trials

Restricted accessResearch articleFirst published June, 2021

Institutionally Chartered Data and Safety Monitoring Boards: Structured Approaches to Assuring Participant Safety in Clinical Research

Blair Holbein, Marie T Rape, Barbara N Hammack [...]

Journal of Investigative Medicine

Restricted accessResearch articleFirst published June, 2004

Use of the false discovery rate for evaluating clinical safety data

Devan V Mehrotra, Joseph F Heyse

Statistical Methods in Medical Research