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Therapeutic Innovation & Regulatory Science|September 22, 2018
Improving Oncology Clinical Programs by Use of Innovative Designs and Comparing Them via SimulationsOlga Marchenko, Joel Miller, Tom Parke, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Can Pharmacovigilance Learn From the Oil and Gas Industry, Which Has Been Outsourcing for Over a Century?Bert P van Leeuwen, Christine Prendergast, Brian Edwards, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Patient Evaluation of Medication Package Leaflets in Al Kharj City, Saudi ArabiaSinaa Alaqeel, Nahed Al ObaidiTherapeutic Innovation & Regulatory Science|September 22, 2018
DIA's Adaptive Design Scientific Working Group (ADSWG): Best Practices Case Studies for "Less Well-understood" Adaptive DesignsEva Miller, Paul Gallo, Weili He, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Developing a Practical Method for Validation of Computerized Systems Integrated With Smart and/or Wearable Devices for Regulatory Compliance of Clinical TrialsYumi Wakabayashi, Hitoshi Matsui, Kohji Ikai, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Adjustment for Propensity Score in Nonrandomized Clinical Studies: Comparison of Sivelestat Versus Conventional Therapy for Acute Lung Injury in Acute Respiratory Distress SyndromeSatoru Fukimbara, Kouji Niibe, Michio Yamamoto, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Methodological Extensions of Phase 2 Trial Designs Based on Program-Level Considerations: Further Development of a Case Study in Neuropathic PainJames Bolognese, Jaydeep Bhattacharyya, Chris Assaid, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Incorporation of a Benefit-Risk Assessment Framework Into the Clinical Overview of Marketing Authorization ApplicationsAnne Wolka, Margaret Warner, Kristin Bullok, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Factors That Affect the Acquisition of Reward Premiums for Promotion of Innovative Drug Discovery in JapanShoyo Shibata, Ryotaro Uemura, Takeshi SuzukiTherapeutic Innovation & Regulatory Science|September 22, 2018
Implementation of the European QRD Template in Package Leaflets of Centralized Approved MedicinesAnna Wolf, Jörg Fuchs, Harald G SchweimPageof 165