FDA's Nakissa Sadrieh and Yanning Hao just published an analysis of NHP data from monoclonal antibody testing that supports streamlining animal testing. For those interested in NAMs, the abstract draws you into to reading more with its brief summary of findings:
"Among the mAbs evaluated, long-term NHP toxicity studies were included in more than half of the development programs but rarely altered regulatory conclusions regarding human risk. Additional findings were predominantly attributable to known pharmacology or species-specific immunogenicity and generally did not affect no-observed-adverse-effect-level (NOAEL) determination, clinical trial design, or labeling. No long-term study in this analysis identified unanticipated off-target toxicities that fundamentally altered the overall safety assessment."
#fda
FDA CDER analysis of non-human primate (NHP) data in monoclonal antibody (mAb) development to support the streamlining of nonclinical safety studies
| Sciencedirect |
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| FDA CDER analysis of non-human primate (NHP) data in monoclonal antibody (mAb) development to support the streamlining of nonclinical safety studies |
| A retrospective analysis of nonclinical study reports submitted in regulatory packages of FDA-approved mAbs, excluding antibody-drug conjugates, was c... |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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