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Class labeling: FDA Concepts and Approach
Affiliation:1. Pharmacokinetics Group, Biological Research Department, Research & Development Division, Sawai Pharmaceutical Co. Ltd., Osaka, Japan;2. Formulation Ⅳ Group, Pharmaceutical Development Department, Research & Development Division, Sawai Pharmaceutical Co. Ltd.;3. Planning Group, New Product Planning Department, Research & Development Division, Sawai Pharmaceutical Co. Ltd.;4. Research & Development Division, Sawai Pharmaceutical Co. Ltd.;1. Certara UK Limited, Simcyp Division, Sheffield, UK;2. University of Sheffield, Sheffield, UK;3. Diurnal Limited, Cardiff, UK
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