Sage Journals: Discover world-class research

Retricted access

Other

First published 2010-9

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

Retricted access

Other

First published 1987-1

Data on Drugs and Adverse Experiences: Moving from the Specific to the General

Dorothy B. Windhorst, Edward F. C. Pun, Lonni A. Zubkoff

Therapeutic Innovation & Regulatory Science

Retricted access

Other

First published 2008-7

Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors

Mary Vanderhoof, Michael J. Umen, David N. Schwartz

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2024

Patient-Readable Radiology Report Summaries Generated via Large Language Model: Safety and Quality

Nicholas W. Sterling, Felix Brann, Stephanie O. Frisch [...]

Journal of Patient Experience

Retricted access

Other

First published 1999-4

ICH M4/The Common Technical Document (CTD): Comparison of Clinical Documents and Summaries Assessment Practices in the United States,Europe,and Japan *

Françoise de Crémiers

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1986-4

A SAS Based System for Reporting Laboratory Data from Clinical Trials

Robert A. Weeks, Norman E. Pitts, Andrew M. Siegel [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Other

First published 2003-9

Acupuncture Research - the First 10 Years in Exeter

E Ernst

Acupuncture in Medicine

Free access

Research article

First published 1991-09

Biologic Effects of Ultrasound

W. R. Hedrick, D. L. Hykes

Journal of Diagnostic Medical Sonography

Retricted access

Research article

First published 2025-10

Pediatric Nurses’ Perceptions of the Quality and Usefulness of Clinical Summaries: Surgeons Versus Generative AI

Nikki Marshall, Emily Carsey, Pauline Chen [...]

Journal of Pediatric Surgical Nursing

Retricted access

Research article

First published 2025-03

Contraception Update: A Focus on Safety and Efficacy

Madeline Cohn, Rachel Novik, Pelin Batur

Journal of Women's Health

Search results