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Therapeutic Innovation & Regulatory Science|September 15, 2018
The Information for the Dosing of Medicinal Products in Different Age Intervals Is AmbiguousNika Zidarič, Samo KreftTherapeutic Innovation & Regulatory Science|May 30, 2018
An Institutional Program to Increase Compliance with Clinicaltrials.gov RequirementsIssis Kelly-Pumarol, Joseph E AndrewsTherapeutic Innovation & Regulatory Science|May 30, 2018
An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug ApplicationPhilip T Lance, Ruth V Greenaway, Brian EdwardsTherapeutic Innovation & Regulatory Science|September 28, 2019
Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory StatusElena Tomaselli Muensterman, Yijia Luo, Jonathon M ParkerTherapeutic Innovation & Regulatory Science|July 20, 2019
Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven AdoptionHilde Vanaken, Shirley N MasandTherapeutic Innovation & Regulatory Science|September 13, 2019
Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMAArnela Boskovic, Mathias Møllebæk, Susanne KaaeTherapeutic Innovation & Regulatory Science|August 21, 2019
Assessing Patient Participation Burden Based on Protocol Design CharacteristicsKenneth Getz, Venkat Sethuraman, Jessica Rine, et al.Therapeutic Innovation & Regulatory Science|November 16, 2018
Cancer Clinical Trials: Treatment Costs Associated With a Spanish National Health System InstitutionFerran Capdevila, Ruth Vera, Patricia Ochoa, et al.Therapeutic Innovation & Regulatory Science|November 16, 2018
Entry Into New Therapeutic Areas: The Effect of Alliance on Clinical TrialsKinya Okada, Shintaro SengokuTherapeutic Innovation & Regulatory Science|November 17, 2018
Costs of Quality in Clinical DevelopmentBolennart ErikssonPageof 165