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What’s the Regulatory Value of a Target Product Profile? |
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| Authors: | Christopher D Breder Wenny Du Adria Tyndall |
| Institution: | 1. Johns Hopkins University, Krieger School of Arts and Sciences, Advanced Academic Programs, Master of Science in Regulatory Science Program, Baltimore, MD, USA;2. US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Drug Evaluation 1, Division of Neurology Products, Silver Spring, MD, USA;3. Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA;4. Catalent Pharma Solutions, LLC, Woodstock, IL, USA |
| Abstract: | |
| Keywords: | time to market product development target product profile |
| 本文献已被 ScienceDirect 等数据库收录！ | |