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Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape |
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| Authors: | Karen M Alsante Kim C Huynh-Ba Steven W Baertschi Robert A Reed Margaret S Landis Scott Furness Bernard Olsen Mark Mowery Karen Russo Robert Iser Gregory A Stephenson Patrick Jansen |
| Institution: | 1. Pfizer Global Research and Development, Groton, Connecticut, USA 2. Pharmalytik Newark, Newark, Delaware, USA 3. Eli Lilly and Company Lilly Research Laboratories, Indianapolis, Indiana, USA 4. Celsion Corporation, Lawrenceville, New Jersey, USA 5. United State Food and Drug Administration, Washington, District of Columbia, USA 6. Olsen Pharmaceutical Consulting, LLC, West Lafayette, Indiana, USA 7. Merck and Co., West Point, Pennsylvania, USA 8. United States Pharmacopeial Convention, Rockville, Maryland, USA |
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| 本文献已被 SpringerLink 等数据库收录！ | |