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By Harshil Shah and Ravi Patel, Cosette Pharmaceuticals Inc. | Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more. |
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| Investing In Capacity – API Commercial Manufacturing | Case Study | Cambrex | A pharma company sought a CMO partner with commercial manufacturing capabilities and expertise as well as exemplary quality systems to find a cost-effective process to produce the API for a new drug. |
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