RESUMO
AIM: Long-term stability testing of drug candidates in biological matrix is a key parameter in bioanalytical method validation. The European Bioanalysis Forum formed a Topic Team to evaluate the use of isochronic design for long-term stability testing of large molecules. METHOD: Isochronic design is based on storage of samples at a reference temperature (below -130°C) where the samples are considered stable. The stability samples are stored at the intended storage temperature and then transferred to the reference temperature, while a set of reference samples is stored the entire storage period at the reference temperature. Stability and reference samples will then be analyzed in one run at the end of the storage period. The mean concentrations of the stability samples are compared either to their nominal concentrations or to the mean concentrations of the reference samples. CONCLUSION: The design minimizes day-to-day variation, reduces workload and adds to the flexibility in the laboratory.
Assuntos
Bioensaio/métodos , Bioensaio/normas , Análise Química do Sangue/métodos , Estabilidade de Medicamentos , Preparações Farmacêuticas/sangue , Preparações Farmacêuticas/química , Animais , Cães , Europa (Continente) , Humanos , Camundongos , Preparações Farmacêuticas/normas , Coelhos , RatosRESUMO
The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendations on biomarker bioanalytical method validation.
Assuntos
Bioensaio/normas , Biomarcadores/análise , Calibragem , Cromatografia Líquida de Alta Pressão/normas , Serviços Contratados/organização & administração , Humanos , Espectrometria de Massas em Tandem/normas , Estudos de Validação como AssuntoRESUMO
An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.