We offer extensive validation of ELISAs according to the “Bioanalytical Method Validation” guideline–published by the FDA in May 2001–and the “Validation of Analytical Procedures: Text and Methodology” guideline, ICH Q2(R1) 2005 (previously Q2A/B).
The measurement of drug concentrations in body fluids (generally in the serum) during clinical trials (Phases I to III) is critical. The context is quite similar to that of biodistribution studies (see Biodistribution section).
Pharmacodynamics (PD) is the measurement of a drug’s efficacy and mechanism of action during clinical trials (Phases I to III). Drug efficacy can be evaluated by quantification of biological markers (cytokines, antibodies, growth factors, etc.).
- “Bioanalytical Method Validation”
- “Note for Guidance on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals”