Month: June 2026
Biotech
GLP
Pharmaceutical
Regulation
Should biomarker bioanalytical methods be validated for a non-clinical tox study
The short answear is: Yes, biomarker bioanalytical methods must be validated for animal toxicity studies, but the rigor of that validation is determined by how the data will be used to make safety or regulatory decisions. In a GLP...
Chemical
Industry
Regulation
Key notes of theOECD Guidance on Grouping of Chemicals
In the rapidly evolving landscape of product safety and drug development, the traditional “test everything” approach is becoming obsolete. Regulatory bodies, including the FDA and ECHA, are increasingly pivoting toward more efficient, humane, and scientifically...
Pharmaceutical
Regulation
The Strategic Role of Pharmacodynamic Assays in Drug Development
In the journey of drug development, we often prioritize Pharmacokinetics (PK)—understanding what the body does to the drug. However, the equally critical counterpart is Pharmacodynamics (PD): the study of what the drug does to the body. PD assays...