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Therapeutic Innovation & Regulatory Science|September 19, 2018
Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical InvestigationFrancis B Palumbo, Lee H Rosebush, Lowell M ZetaTherapeutic Innovation & Regulatory Science|September 19, 2018
Bone Mineral Density to Assess Pediatric Bone Health in Drug DevelopmentBrian M Maas, Jian Wang, Freda Cooner, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Dose Finding in Late-Phase Drug DevelopmentLei Nie, Kyung Y Lee, Nicole Verdun, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Optimized Medical Product Regulation in Mexico: A Win-Win for Public and Economic HealthMikel Andoni Arriola Peñalosa, Ricardo Cavazos Cepeda, Mario Alanis Garza, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Assessing Recall and Recognition for Important Safety Information in Digital Promotion for Pharmaceutical Products: Implications for Website DesignMichael Polster, Clifford Thumma, Pamela C Trainer, et al.Therapeutic Innovation & Regulatory Science|September 20, 2018
Timeliness of a Signal Detection Process as a Component of Effectiveness Assessment in a Drug Safety Department of a Large Pharmaceutical Company: Review Over a 5-Year PeriodKiran B Bapatla, Philippe Close, Gopal Sharma, et al.Therapeutic Innovation & Regulatory Science|September 20, 2018
Competitive Strategies for Japanese Clinical Trial Sites: A New Approach to QualityToshiyoshi TominagaTherapeutic Innovation & Regulatory Science|September 20, 2018
Risk Evaluation and Mitigation Strategies With Elements to Assure Safe Use: Alignment of the Goals With the Tools to Manage RiskMichael Cronin, Susan Berger, Paul J SeligmanTherapeutic Innovation & Regulatory Science|September 20, 2018
Corporate Integrity Agreements: What They Say About Publications, Publication Planning, Transparency, and ICMJEFrank J RodinoTherapeutic Innovation & Regulatory Science|September 20, 2018
Data Quality Improvement in Clinical Databases Using Statistical Quality Control: Review and Case StudyHassan Assareh, Mary A Waterhouse, Christina Moser, et al.Pageof 165