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By Anupreet Kaur, Frank Delaglio, Subrata H. Mishra, John P. Marino, and Robert G. Brinson IBBR, NIST and the University of Maryland | Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations. |
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By Jayet Moon and Arun Mathew | The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024. |
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| Is It Ever Too Soon To Start Your Performance Testing Assessment? | Article | By Mike Ulman, West Pharmaceutical Services, Inc. | Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing. |
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