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Therapeutic Innovation & Regulatory Science|September 21, 2018
An Analysis of Japanese Patients Enrolled in Multiregional Clinical Trials in OncologyAkihiro Hirakawa, Fumie KinoshitaTherapeutic Innovation & Regulatory Science|September 21, 2018
Challenges With the Development of Biosimilars in Asia for Western Markets: An Overview and Suggested SolutionsRaymond A Huml, Oxana Iliach, Kamali Chance, et al.Therapeutic Innovation & Regulatory Science|September 21, 2018
Reconciling States' "Right to Try" Legislation and FDA's Expanded Access Program: Legal IssuesRobyn S ShapiroTherapeutic Innovation & Regulatory Science|September 21, 2018
A Global Perspective on Compassionate Use and Expanded AccessTom WatsonTherapeutic Innovation & Regulatory Science|September 21, 2018
Who Stands to Benefit? Right to Try Law Provisions and ImplicationsLisa Kearns, Alison Bateman-HouseTherapeutic Innovation & Regulatory Science|September 21, 2018
Sample Size Calculations for Combination Drugs of 2 Monotherapies With a Single Approved Dose Level: Binary Endpoint CasesSeung-Ho Kang, Juhee ParkTherapeutic Innovation & Regulatory Science|September 21, 2018
Pharmaceutical Organizational Size and Phase 3 Clinical Trial Completion TimesHarold E Glass, Lucas M Glass, Phuong Tran, et al.Therapeutic Innovation & Regulatory Science|September 21, 2018
A Toolkit for the Management of Protocol DeviationsSandy Mohan, Munish Mehra, Maryrose Petrizzo, et al.Therapeutic Innovation & Regulatory Science|September 21, 2018
An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research: 2003 Through 2014Khushboo Sharma, Afi Harrington, Sallamar Worrell, et al.Therapeutic Innovation & Regulatory Science|September 21, 2018
TransCelerate's Clinical Quality Management System: Issue ManagementSusan Callery-D'Amico, Leslie M Sam, Timothy H Grey, et al.Pageof 165