The state of the art in secondary pharmacology and its impact on the safety of new medicines.
Nat Rev Drug Discov
; 23(7): 525-545, 2024 07.
Article
in En
| MEDLINE
| ID: mdl-38773351
ABSTRACT
Secondary pharmacology screening of investigational small-molecule drugs for potentially adverse off-target activities has become standard practice in pharmaceutical research and development, and regulatory agencies are increasingly requesting data on activity against targets with recognized adverse effect relationships. However, the screening strategies and target panels used by pharmaceutical companies may vary substantially. To help identify commonalities and differences, as well as to highlight opportunities for further optimization of secondary pharmacology assessment, we conducted a broad-ranging survey across 18 companies under the auspices of the DruSafe leadership group of the International Consortium for Innovation and Quality in Pharmaceutical Development. Based on our analysis of this survey and discussions and additional research within the group, we present here an overview of the current state of the art in secondary pharmacology screening. We discuss best practices, including additional safety-associated targets not covered by most current screening panels, and present approaches for interpreting and reporting off-target activities. We also provide an assessment of the safety impact of secondary pharmacology screening, and a perspective on opportunities and challenges in this rapidly developing field.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Drug-Related Side Effects and Adverse Reactions
Limits:
Animals
/
Humans
Language:
En
Journal:
Nat Rev Drug Discov
/
Nat. rev., Drug discov. (Print)
/
Nature reviews. Drug discover (Print)
Journal subject:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Year:
2024
Document type:
Article
Affiliation country:
Estados Unidos
Country of publication:
Reino Unido