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When designing an upstream manufacturing process for Phase 1 clinical studies, you should: Design a fully-characterized, robust process. Run a platform process without any evaluation
When designing an upstream manufacturing process for Phase 1 clinical studies, you should: Design a fully-characterized, robust process. Run a platform process without any evaluation prior to GMP. Run a platform process confirming process performance and quality for toxicology runs prior to GMP
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Auditing Cases An Interactive Learning Approach
Authors: Steven M Glover, Douglas F Prawitt
4th Edition
0132423502, 978-0132423502
