TK/PK - Biomarkters & PD
Measurement of drug concentrations in body fluids (generally in the serum) during clinical trials (Phases I to III). The context is quite similar to that of biodistribution studies (see Biodistribution section). We offer extensive validation of your ELISA according to the “Bioanalytical method validation” guideline (published by the FDA in May 2001) and the ICH Q2(R1) 2005 (previously Q2A/B) “Validation of analytical procedures: text and methodology” guideline.
Main Guidelines:
FDA/CDER/May 2001 “Bioanalytical method validation”
ICH S6 (CPMP/ICH/302/95) “Note for guidance on preclinical safety evaluation of biotechnology-derived pharmaceuticals”
Pharmacodynamics
Measurement of a drug's efficacy during clinical trials (Phases I to III). Drug efficacy can be evaluated by quantification of biological markers (cytokines, antibodies, growth factors, etc.). We offer extensive validation of ELISAs according to the “Bioanalytical method validation” guideline (published by the FDA in May 2001) and the ICH Q2(R1) 2005 (previously Q2A/B) “Validation of analytical procedures: text and methodology” guideline.
Main Guidelines:
FDA/CDER/May 2001 “Bioanalytical method validation”
ICH S6 (CPMP/ICH/302/95) “Note for guidance on preclinical safety evaluation of biotechnology-derived pharmaceuticals”
