Use of Proprietary Names by Prescribers for Generic Products

JOURNAL ARTICLE published March 2018 in Therapeutic Innovation & Regulatory Science

Authors: Vicky Borders-Hemphill | Irene Z. Chan | Katelyn Brown | Briana Rider | Kellie Taylor | Grace Chai

Vulnerability and Clinical Research: Mapping the Challenges for Stakeholders

JOURNAL ARTICLE published September 2020 in Therapeutic Innovation & Regulatory Science

Authors: Pierre Mermet-Bouvier | Matthew D. Whalen

Data-Driven Subgroup Identification in Confirmatory Clinical Trials

JOURNAL ARTICLE published January 2022 in Therapeutic Innovation & Regulatory Science

Authors: Pierre Bunouf | Mélanie Groc | Alex Dmitrienko | Ilya Lipkovich

Reasons for Premature Conclusion of Late Phase Clinical Trials: An Analysis of ClinicalTrials.gov Registered Phase III Trials

JOURNAL ARTICLE published January 2020 in Therapeutic Innovation & Regulatory Science

Authors: Daphne Guinn | Erin E. Wilhelm | Ira Shoulson

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

Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in Japan

JOURNAL ARTICLE published July 2018 in Therapeutic Innovation & Regulatory Science

Authors: Shoyo Shibata | Maiko Matsushita | Yoshimasa Saito | Takeshi Suzuki

Managing Team Innovation in the Research and Development (R&D) Organization: Critical Determinants of Team Effectiveness

JOURNAL ARTICLE published November 2015 in Therapeutic Innovation & Regulatory Science

Authors: Rajesh Krishna | Hongwei He

Using Individual Experiences With Experimental Medications to Predict Medication-Taking Behavior Postauthorization: A DIA Study Endpoints Workstream

JOURNAL ARTICLE published July 2017 in Therapeutic Innovation & Regulatory Science

Authors: Matthew Reaney | Colleen A. McHorney | Bradley Curtis | Anna Rydén | Olivier Chassany | Chad Gwaltney

A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products

JOURNAL ARTICLE published May 2017 in Therapeutic Innovation & Regulatory Science

Authors: Hideyuki Kondo | Toshiki Sugita | Naoko Ida | Hiroko Fukushima | Naoyuki Yasuda

Who Stands to Benefit? Right to Try Law Provisions and Implications

JOURNAL ARTICLE published March 2017 in Therapeutic Innovation & Regulatory Science

Authors: Lisa Kearns | Alison Bateman-House

An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees

JOURNAL ARTICLE published September 2015 in Therapeutic Innovation & Regulatory Science

Authors: Jonathan Seltzer

Statistical Considerations on Clinical Efficacy Studies of Biosimilar for PMDA Submission

JOURNAL ARTICLE published September 2020 in Therapeutic Innovation & Regulatory Science

Authors: Yumiko Asami | Jean Pan | MyungShin Oh | Akira Sato

Social Media Monitoring and Adverse Drug Reaction Reporting in Pharmacovigilance: An Overview of the Regulatory Landscape

JOURNAL ARTICLE published January 2017 in Therapeutic Innovation & Regulatory Science

Authors: Marina Lengsavath | Anne Dal Pra | Anne-Marie de Ferran | Sabine Brosch | Linda Härmark | Victoria Newbould | Susana Goncalves