ARTICLES BY ERIKA L. ROBERTS
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10/3/2023
The FDA has announced a new draft guidance titled Clinical Pharmacology Considerations for Peptide Drug Products.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.
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7/28/2023
Ribonucleic acid (RNA), once considered a mere messenger molecule, has now emerged as a versatile tool in the development of novel therapies. In this article, we will delve into the world of RNA therapeutics, exploring their potential and five applications that could impact the future of medicine.
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5/25/2023
Aptamers offer advantages over antibodies, including lower immunogenicity and toxicity, better tissue penetration, lower production costs, and a very long shelf life. Why, then, have we not seen more of these come to market? Two hurdles have stood in the way until recently.