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Therapeutic Innovation & Regulatory Science|September 19, 2018
Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals: Frequency of Adverse Reactions Observed During Supplemental Approval Compared With First ApprovalNobuyuki Sekine, Yasuo Ohashi, Atsushi Aruga
Therapeutic Innovation & Regulatory Science|September 19, 2018
Mobile Nurse Services in Clinical Trials: Usage and Industry PerceptionsStella Stergiopoulos, Conor Eustace, Komathi Stem, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Reporting Adverse Drug Reactions in Product LabelsBrenda Crowe, Christy Chuang-Stein, Sally Lettis, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014Martin Offringa, Jonathan M Davis, Mark A Turner, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring CommitteesJonathan Seltzer
Therapeutic Innovation & Regulatory Science|September 19, 2018
Incentivizing Quality in the Manufacture of Pharmaceuticals: Industry Views on Quality Metrics and RatingsCesar Medina, Frances J Richmond
Therapeutic Innovation & Regulatory Science|September 19, 2018
Food and Drug Administration Requirements for Clinical Studies in Pediatric PatientsEdward Tabor
Therapeutic Innovation & Regulatory Science|September 19, 2018
Patient-Centered Therapy Development for Myotonic Dystrophy: Report of the Myotonic Dystrophy Foundation-Sponsored WorkshopSharon Hesterlee, Shashi Amur, Lisa J Bain, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Key Elements of Pharmacoinformatics for the Degrees of Bachelor and Master of PharmacyImas Nur Amelia Zainal, Nur Amirah Abd Karim, Yee Chang Soh, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Mobile Medical Applications for Dosage Recommendation, Drug Adverse Reaction, and Drug Interaction: Review and ComparisonNur Amirah Apidi, Muthu Kumar Murugiah, Rajendran Muthuveloo, et al.
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