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Therapeutic Innovation & Regulatory Science|September 22, 2018
Quantitative Extrapolation: An Approach to Validation of Adult Drug Efficacy in Pediatric SubjectsTarek A Leil, Pamela Zee, Satyendra Suryawanshi, et al.
Therapeutic Innovation & Regulatory Science|September 22, 2018
The ICH, the GHTF, and the Future of Harmonization InitiativesToshiyoshi Tominaga
Therapeutic Innovation & Regulatory Science|September 22, 2018
Regulations of Medical Devices in Regulated Countries: A Comparative ReviewG V S S N Jyothi, M P Venkatesh, T M Pramod Kumar
Therapeutic Innovation & Regulatory Science|September 22, 2018
ICH Culture: Its Maintenance and DevelopmentHironobu Saito, Masafumi Yokota, Akira Kawahara, et al.
Therapeutic Innovation & Regulatory Science|September 22, 2018
Addressing Challenges and Opportunities of "Less Well-Understood" Adaptive DesignsWeili He, Paul Gallo, Eva Miller, et al.
Therapeutic Innovation & Regulatory Science|September 22, 2018
Patient Access in Restrictive Risk Management Programs: The Case of iPLEDGEKirk W Kerr, Marta E Wosinska
Therapeutic Innovation & Regulatory Science|September 22, 2018
FDA's Expedited Programs and Their Impact on the Availability of New TherapiesNehar Damle, Shilvi Shah, Praneeta Nagraj, et al.
Therapeutic Innovation & Regulatory Science|September 22, 2018
Current Practices in Choosing Estimands and Sensitivity Analyses in Clinical Trials: Results of the ICH E9 SurveyC Fletcher, S Tsuchiya, D V Mehrotra
Therapeutic Innovation & Regulatory Science|September 22, 2018
Practical Considerations for the Use of Clinical Outcome Assessments (COAs) in Pediatric Clinical Research: Examples From Pediatric GastroenterologySarrit M Kovacs, Diane M Turner-Bowker, Gina Calarco, et al.
Therapeutic Innovation & Regulatory Science|September 22, 2018
Impact of Premium Rewards for the Promotion of Innovative Drug Discovery on the Japanese Pharmaceutical Market: An Analysis by Therapeutic AreaShoyo Shibata, Ryotaro Uemura, Takeshi Suzuki
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