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Therapeutic Innovation & Regulatory Science|September 21, 2018
Regulation of New Drug Approval in TaiwanYa-Ting Yang, Hsiau-Wen Huang, Ya-Ting Chen, et al.
Therapeutic Innovation & Regulatory Science|September 21, 2018
A Patient Centricity Team Tool to Enable Patient-Focused Drug DevelopmentRebecca Ashkenazy, Roslyn F Schneider
Therapeutic Innovation & Regulatory Science|September 21, 2018
Do Patients Use a Headline Section in a Leaflet to Find Key Information About Their Medicines? Findings From a User-Test StudyRebecca Dickinson, David K Raynor, Peter Knapp, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
CBER's Experience With Adaptive Design Clinical TrialsMin Lin, Shiowjen Lee, Boguang Zhen, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Comparative Analysis Between the Top-Selling Drugs in the Japanese Pharmaceutical Market and Those in the United States, the United Kingdom, France, and GermanyShoyo Shibata, Ryotaro Uemura, Takeshi Suzuki
Therapeutic Innovation & Regulatory Science|September 19, 2018
Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or MisconductDavid Knepper, Anne S Lindblad, Gaurav Sharma, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Who Said It Better? A Test of Wording Differences in the MedWatch "Toll-Free Statement" for Consumer Reporting of Side Effects in Direct-to-Consumer Television AdvertisementsKathryn J Aikin, Amie C O'Donoghue, Helen W Sullivan, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
An Overview of the Regulatory and Developmental Strategies of ChronotherapeuticsMohd Aamir Mirza, Faiyaz Shakeel, Zeenat Iqbal
Therapeutic Innovation & Regulatory Science|September 19, 2018
The Impact of Protocol Amendments on Clinical Trial Performance and CostKenneth A Getz, Stella Stergiopoulos, Mary Short, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
TransCelerate's Clinical Quality Management System: From a Vision to a Conceptual FrameworkAnn Meeker-O'Connell, Leslie M Sam, Nanci Bergamo, et al.
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