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Therapeutic Innovation & Regulatory Science|February 3, 2020
Determinants of Generic Drug Substitution in the United StatesJodi B Segal, Oluwadamilola Onasanya, Matthew Daubresse, et al.
Therapeutic Innovation & Regulatory Science|February 3, 2020
The Power Derivative Principle, and Its Application to How and When to Perform a One-Shot Unblinded Reassessment Sample SizeElodie Blondiaux, Eric Derobert
Therapeutic Innovation & Regulatory Science|February 3, 2020
Investigation of Approval Trends and Benefits of New Fixed-Dose Combination Drugs in JapanChikara Kikuchi, Mifuyu Ohno, Takafumi Izumo, et al.
Therapeutic Innovation & Regulatory Science|November 28, 2019
Tying Medicare Part B Drug Prices to International Reference Pricing Will Devastate R&DDuane Schulthess, Daniel Gassull, Steven Maisel
Therapeutic Innovation & Regulatory Science|December 1, 2020
Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm BirthSarah Sheehan, Gerri Baer, Morgan Romine, et al.
Therapeutic Innovation & Regulatory Science|December 1, 2020
Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration InitiativeTariro Sithole, Gugu Mahlangu, Sam Salek, et al.
Therapeutic Innovation & Regulatory Science|December 1, 2020
Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic EvaluationDaphne Guinn, Rajanikanth Madabushi, Yow-Ming Wang, et al.
Therapeutic Innovation & Regulatory Science|December 10, 2020
A Novel Collaborative Approach to Building Better Clinical Trials: New Insights From a Patient Engagement Workshop to Propel Patient-Centricity ForwardAlyson Gregg, Nova Getz, Jasmine Benger, et al.
Therapeutic Innovation & Regulatory Science|December 10, 2020
FDA Reported Use of Patient Experience Data in 2018 Drug ApprovalsCameron M Kieffer, Alexis Reisin Miller, Benjamin Chacko, et al.
Therapeutic Innovation & Regulatory Science|December 10, 2020
Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in JapanKentaro Sakamaki, Seitaro Yoshida, Yusuke Morita, et al.
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