A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities - The AAPS Journal
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| A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities - The AAPS Journal |
| There is limited regulatory guidance that outlines the globally acceptable level of individual and total impurities present in peptide and oligonucleotide drug substances that can be supported and accepted during clinical testing. |
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Pankajini Mallick Ph.D.
Sr. Principal Scientist, Preclinical Pharmacokinetics | Modeling and Simulation
San Diego CA
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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