Safety studies: what is required, and what it costs in time

SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.

Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.

With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.

Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.

Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.

Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.

PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.

Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.

Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.