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Therapeutic Innovation & Regulatory Science|September 19, 2018
Evaluation of an Adaptive Maximizing Design Study Based on Clinical Utility Versus Morphine for TRV130 Proof-of-Concept and Dose-Regimen Finding in Patients With Postoperative Pain After BunionectomyJames A Bolognese, Ruth Ann Subach, Franck SkobierandaTherapeutic Innovation & Regulatory Science|September 19, 2018
Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs: Update, July 2010 to June 2014Frank J Sasinowski, Erika B Panico, James E ValentineTherapeutic Innovation & Regulatory Science|September 19, 2018
Center for Drug Evaluation and Research Perspective on Quality in Clinical TrialsStephanie Shapley, Jacqueline O'Shaughnessy, Janet WoodcockTherapeutic Innovation & Regulatory Science|September 19, 2018
Compliance of Community Pharmacists and Private General Medical Practitioners With Malaysian Laws on Poisons and Sale of DrugsChuo Yew Ting, Shing Chyi Loo, Hiram Ting, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Using Individual Experiences With Experimental Medications to Predict Medication-Taking Behavior Postauthorization: A DIA Study Endpoints WorkstreamMatthew Reaney, Colleen A McHorney, Bradley Curtis, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
The Enigma of Pharmacovigilance of Patient Support Programs: A Survey of Marketing Authorization Holders in EuropeJamie Michelle Portnoff, David John LewisTherapeutic Innovation & Regulatory Science|September 19, 2018
One Patient Is Not One Condition: Delivering Patient-Centered Care to Those With Multiple Chronic ConditionsJan Liska, Anne BealTherapeutic Innovation & Regulatory Science|September 19, 2018
Typographic Changes in Package Leaflets of the European Union Based on the Example of German Versions Between 2005 and 2015Jörg Fuchs, Saskia Kraft, Annina Vettermann, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Challenges in the Ethical Review of Research Involving Complementary and Integrative MedicineJeffrey A Cooper, David Borasky, Stephen Rosenfeld, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design ApproachKiyohito Kuno, Satoshi ToyoshimaPageof 165