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Therapeutic Innovation & Regulatory Science|September 22, 2018
ICH: Strengths, Weaknesses, and Future TasksSebastian Specht, Ingrid KlingmannTherapeutic Innovation & Regulatory Science|September 22, 2018
A Practical Guide to Data Monitoring Committees in Adaptive TrialsMatilde Sanchez-Kam, Paul Gallo, John Loewy, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
New Governance Mechanisms to Optimize Protocol DesignKenneth A Getz, Jennifer Kim, Stella Stergiopoulos, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Rheumatoid Arthritis Disease Progression ModelingRussell Reeve, Lei Pang, Bradley Ferguson, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Teratogenic Drugs and Risk Management: An Implementation AssessmentJohn Freeman, Robert Bwire, Florence Houn, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Academic Clinical Trials and Drug Regulations in Japan: Impacts of Introducing the Investigational New Drug SystemHisashi Urushihara, Koji KawakamiTherapeutic Innovation & Regulatory Science|September 22, 2018
Role of Patient-Reported Outcome Measures in the Assessment of Central Nervous System AgentsAri Gnanasakthy, Carla DeMuro, Marci Clark, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Industry Survey on Current Practices in the Assessment of Palatability and Swallowability in the Development of Pediatric Oral Dosage FormsCharles A Thompson, Donald P Lombardi, Philip Sjostedt, et al.Therapeutic Innovation & Regulatory Science|September 22, 2018
Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration, 2010-2015: Implications for Designing a Regulatory Shortcut to New Drug ApplicationKyu Chan Kwon, Chulung LeeTherapeutic Innovation & Regulatory Science|September 22, 2018
An Update on the Registration of Biosimilars in MalaysiaYvonne Siew Khoon Khoo, Tien Yew Tang, Pick Sim Goh, et al.Pageof 165