Considerations for the genotoxicity assessment of middle size peptide drugs containing non-canonical amino acid residues
Masayuki Mishima, Kei-ichi Sugiyama · 2023
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Description
Masayuki Mishima and Kei-ichi Sugiyama weigh how to test mid-size peptide drugs for DNA damage. Their 2023 paper sits at a rule boundary: small chemical drugs must pass genotoxicity tests, while large biologic drugs skip them. Mid-size peptides, a rising drug class, borrow traits from both sides, and some carry unnatural amino acids that standard thinking never covered.
The authors argue the small-drug rulebook mostly fits, since these peptides are built and dosed more like chemicals. But they propose a few changes to the standard test set where peptide traits make the usual assays mislead. The paper is guidance for developers and regulators meeting this in-between class.
Catalog record
| CREATOR | Masayuki Mishima, Kei-ichi Sugiyama |
|---|---|
| YEAR | 2023 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 15 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |