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Therapeutic Innovation & Regulatory Science|January 30, 2022
Optimal Sample Size for Use in Neonatal Pharmacokinetic StudiesBo-Hao Tang, Bu-Fan Yao, John van den Anker, et al.
Therapeutic Innovation & Regulatory Science|January 30, 2022
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial PerformanceZachary Smith, Ralf Bilke, Sybrand Pretorius, et al.
Therapeutic Innovation & Regulatory Science|April 28, 2022
Randomized Controlled Trial Data for New Drug Application for Rare Diseases in JapanYosuke Kubota, Mamoru Narukawa
Therapeutic Innovation & Regulatory Science|April 5, 2022
Regulation of Drug Prescribing Information in Latin America and the CaribbeanMariana Ramírez-Telles, Urimara Argotti-Rodríguez
Therapeutic Innovation & Regulatory Science|April 26, 2022
False Negative ECG Device Results May Increase the Risk of Adverse Events in Clinical Oncology TrialsLuc Dekie, Robert B Kleiman
Therapeutic Innovation & Regulatory Science|August 31, 2018
Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA MeetingDavid G Strauss, Gary Gintant, Zhihua Li, et al.
Therapeutic Innovation & Regulatory Science|May 16, 2019
Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug DevelopmentMargaret Gamalo-Siebers, Lisa Hampson, Kattayoun Kordy, et al.
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