Search results: Sage Journals

Restricted accessOtherFirst published January, 1998

Preparing an Integrated Summary of Safety: A Writer's Perspective

Sharie Myers, Beth Baron, Lyn Radke-Mitchell [...]

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published September, 2010

Understanding the Differences and Effectively Transitioning between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS)

David N. Schwartz, Michael J. Umen, Kathy Nomides [...]

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1991

Can There Really Be an Integrated Safety Summary?

Thomas Q. Garvey

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1991

The Regulatory Evolution of the Integrated Safety Summary

Robert J. Temple

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1991

Preface: Preparation of an Integrated Safety Summary for a New Drug Application

David M. Cocchetto, Cheryl F. Graham

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1991

Approaches to Describing Common Adverse Events in the Integrated Safety Summary

Charles Lineberry

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 1994

Current Reporting Methods for Laboratory Data at Zeneca Pharmaceuticals

Jill M. Davis

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 2000

Pooling in Integrated Safety Databases

Damian J. McEntegart

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published August, 2009

Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

Biotechnology Law Report

Restricted accessResearch articleFirst published March, 1994

The effects of inhaled corticosteroids on the endocrine system

P.I. Folb

International Journal of Risk & Safety in Medicine

Restricted accessOtherFirst published January, 1998

Preparing an Integrated Summary of Safety: A Writer's Perspective

Sharie Myers, Beth Baron, Lyn Radke-Mitchell [...]

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published September, 2010

Understanding the Differences and Effectively Transitioning between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS)

David N. Schwartz, Michael J. Umen, Kathy Nomides [...]

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1991

Can There Really Be an Integrated Safety Summary?

Thomas Q. Garvey

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1991

The Regulatory Evolution of the Integrated Safety Summary

Robert J. Temple

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1991

Preface: Preparation of an Integrated Safety Summary for a New Drug Application

David M. Cocchetto, Cheryl F. Graham

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1991

Approaches to Describing Common Adverse Events in the Integrated Safety Summary

Charles Lineberry

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 1994

Current Reporting Methods for Laboratory Data at Zeneca Pharmaceuticals

Jill M. Davis

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 2000

Pooling in Integrated Safety Databases

Damian J. McEntegart

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published August, 2009

Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

Biotechnology Law Report

Restricted accessResearch articleFirst published March, 1994

The effects of inhaled corticosteroids on the endocrine system

P.I. Folb

International Journal of Risk & Safety in Medicine