The FDA has announced a new draft guidance titled Clinical Pharmacology Considerations for Peptide Drug Products. This guidance describes recommendations related to hepatic impairment, drug-drug interactions, assessing QTc prolongation risk, and more. The public comment period ends December 11, 2023.
Improving Efficiency In Cell Line Development
As the cost of developing a biologic drug remains high, explore ways to improve your CLD process by eliminating bottlenecks in clone selection, fast-tracking timelines, and reducing costs.
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