Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development

JOURNAL ARTICLE published September 2021 in Therapeutic Innovation & Regulatory Science

Authors: Timothé Ménard | Alaina Barros | Christopher Ganter

Investigation of Characteristics of Japanese Clinical Trials in Terms of Data Variability

JOURNAL ARTICLE published July 2013 in Therapeutic Innovation & Regulatory Science

Authors: Kazuhiro Kanmuri | Mamoru Narukawa

Editor-in-Chief’s Commentary: Collaborate to Innovate

JOURNAL ARTICLE published March 2014 in Therapeutic Innovation & Regulatory Science

Authors: Stephen P. Spielberg

Impact of Risk-Benefit Perception and Trust on Medical Technology Acceptance in Relation to Drug and Device Lag: A Tripartite Cross-Sectional Survey

JOURNAL ARTICLE published September 2018 in Therapeutic Innovation & Regulatory Science

Research funded by Ministry of Health, Labour and Welfare (Health Labour Sciences Research Grant (Japan), res)

Authors: Koji Todaka | Junji Kishimoto | Masayuki Ikeda | Koji Ikeda | Haruko Yamamoto

Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events)

JOURNAL ARTICLE published March 2019 in Therapeutic Innovation & Regulatory Science

Authors: Hanne Theilgaard | on behalf of the DEVOTE Study Group | Inger Mollerup | Ida Carøe Helmark | Lars Endahl | Shawn Hoskin | Anders Hvelplund | Lene Klixbüll Amby | Alan C. Moses

Patient Access in Restrictive Risk Management Programs: The Case of iPLEDGE

JOURNAL ARTICLE published January 2017 in Therapeutic Innovation & Regulatory Science

Authors: Kirk W. Kerr | Marta E. Wosinska

Multifaceted Paths Toward Advancing Regulatory Science

JOURNAL ARTICLE published July 2015 in Therapeutic Innovation & Regulatory Science

Authors: Stephen P. Spielberg

DIA Then and Now: A Half-Century Odyssey

JOURNAL ARTICLE published September 2017 in Therapeutic Innovation & Regulatory Science

Authors: J. Rick Turner

A Practical Estimation Method for Analyzing Adverse Drug Reactions Using Data Mining

JOURNAL ARTICLE published March 2013 in Therapeutic Innovation & Regulatory Science

Authors: Yuko Shirakuni | Kousuke Okamoto | Etuko Uejima | Shigeki Inui | Jun-ichi Takahara | Takanori Ohgaru | Hiroyuki Yamasaki | Yushi Tian | Norihito Kawashita | Ran Inoue | Teruo Yasunaga | Tatsuya Takagi

Peptide Phage Display: Molecular Principles and Biomedical Applications

JOURNAL ARTICLE published March 2020 in Therapeutic Innovation & Regulatory Science

Authors: Marlon S. Zambrano-Mila | Karen Elizabeth Sánchez Blacio | Nelson Santiago Vispo

Adaptive Design: Results of 2012 Survey on Perception and Use

JOURNAL ARTICLE published July 2014 in Therapeutic Innovation & Regulatory Science

Authors: Caroline Claire Morgan | Susan Huyck | Martin Jenkins | Li Chen | Alun Bedding | Christopher S. Coffey | Brenda Gaydos | J. Kyle Wathen

The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

JOURNAL ARTICLE published May 2020 in Therapeutic Innovation & Regulatory Science

Authors: Beata Wilkinson | Robert van Boxtel

Global Regulatory Dissonance: A Case Study of Industry Views on the Development of Drugs for Postmenopausal Osteoporosis

JOURNAL ARTICLE published March 2015 in Therapeutic Innovation & Regulatory Science

Authors: Neal E. Storm | Frances J. Richmond

The Impact of Innovation: How the Changing Nature of Data Will Challenge FDA’s Regulatory Framework

JOURNAL ARTICLE published May 2017 in Therapeutic Innovation & Regulatory Science

Authors: Michael Doherty | Nancy Bradish Myers | Anne Petruska McNickle

phactMI Benchmarking Survey on Content Development and Inquiry Management

JOURNAL ARTICLE published November 2020 in Therapeutic Innovation & Regulatory Science

Authors: Jacqueline Byun | Jin Ah Jong | Amina Gangat | Teresa Flowers | Andrew Gazo | Ina Shah

Study Designs in Multi-arm Trials for Breast Cancer: A Systematic Literature Review of Major Journals

JOURNAL ARTICLE published September 2020 in Therapeutic Innovation & Regulatory Science

Authors: Shogo Nomura | Yu Miyauchi | Yoshikazu Ajisawa | Kento Isogaya | Takashi Sozu

Measuring Blood Pressure in Clinical Practice: We Can and Must Do Better

JOURNAL ARTICLE published November 2018 in Therapeutic Innovation & Regulatory Science

Authors: J. Rick Turner

Evaluating Literature for Oncology Data Gaps to Improve the Quality of Standard Response Letters: A Retrospective Review

JOURNAL ARTICLE published 9 April 2019 in Therapeutic Innovation & Regulatory Science

Authors: Shanada Monestime

A Model for the Role of TIRS in Helping to Develop and Validate Best Practices Across Clinical Trial Management

JOURNAL ARTICLE published September 2014 in Therapeutic Innovation & Regulatory Science

Authors: Stephen P. Spielberg

A Method of Addressing Proprietary Name Similarity for US Prescription Drugs

JOURNAL ARTICLE published July 2015 in Therapeutic Innovation & Regulatory Science

Authors: Melissa D. Stockbridge | Kellie Taylor