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Therapeutic Innovation & Regulatory Science|July 14, 2023
Application of Statistical Methods for Central Statistical Monitoring and Implementations on the German Multiple Sclerosis RegistryFiras Fneish, David Ellenberger, Niklas Frahm, et al.
Therapeutic Innovation & Regulatory Science|June 25, 2023
A Detailed Analysis of the Past 20 Years of US FDA-Approved Prescription to Over-the-Counter SwitchesMatt Fisher, Kapil Rawal
Therapeutic Innovation & Regulatory Science|December 5, 2018
Clinical Development of Biologics Approved by the US Food and Drug Administration, 2003-2016G Caleb Alexander, Ken Ogasawara, Dana Wiegand, et al.
Therapeutic Innovation & Regulatory Science|September 25, 2020
Accelerating Rare Disease Drug Development: Lessons Learned from Muscular Dystrophy Patient Advocacy GroupsRaymond A Huml, Jill Dawson, Michelle Bailey, et al.
Therapeutic Innovation & Regulatory Science|January 15, 2020
Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An OverviewAtul Sharma, Shyam Khante, Kakasaheb R Mahadik, et al.
Therapeutic Innovation & Regulatory Science|January 15, 2020
Harmonizing Protocol Complexity with Resource Management and Capacity Planning at Clinical Research SitesDavid J Morin
Therapeutic Innovation & Regulatory Science|September 1, 2020
Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung CancerPhil Bonomi, Nina Stuccio, C J Delgra, et al.
Therapeutic Innovation & Regulatory Science|September 30, 2020
Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product DevelopmentBrian Perry, Carrie Dombeck, Jaye Bea Smalley, et al.
Therapeutic Innovation & Regulatory Science|December 1, 2020
Proposed Best Practice Guidelines for Scientific Response Documents: A Consensus Statement from phactMIEvelyn R Hermes-DeSantis, Renee M Johnson, Alysa Redlich, et al.
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