RESUMO
With 10 years of experiences on incurred sample reanalysis (ISR) as an integrated part of regulated bioanalysis, the European Bioanalysis Forum has reflected on the implementation and the use of ISR. Three surveys were conducted in 2016 and 2017 as a revisit of the ISR experiences within European pharmaceutical industry and contract research organizations: has ISR become a tool for postvalidation and process check of a bioanalytical method performance and has ISR become a routine in our laboratories? Do we agree on the interpretation of guidelines/guidance and are we aligned in our approach - among others?
Assuntos
Desenvolvimento de Medicamentos , Indústria Farmacêutica , Controle de Qualidade , Reprodutibilidade dos Testes , Animais , Técnicas de Química Analítica/métodos , Técnicas de Química Analítica/normas , Desenvolvimento de Medicamentos/métodos , Desenvolvimento de Medicamentos/normas , Indústria Farmacêutica/métodos , Indústria Farmacêutica/normas , Europa (Continente) , Humanos , Farmacocinética , Testes de Toxicidade/métodos , Testes de Toxicidade/normas , Estudos de Validação como AssuntoRESUMO
Following intensive discussions, review, alignment of procedures and multiple surveys among their member companies, the European Bioanalysis Forum (EBF) is providing a recommendation on how to integrate incurred sample reproducibility (ISR) in the bioanalytical process. The recommendation aims to provide guidance throughout the lifecycle of a validated method, including the application of the method in study support. In its recommendation, the EBF considers both the internal discussions with EBF member companies, as well as the input provided in international meetings where ISR was discussed. The ultimate goal of the EBF recommendation is to ensure that bioanalytical methods can provide accurate and reproducible concentration data for pharmacokinetic and/or toxicokinetic evaluation, without any compromise, while safeguarding the optimal use of laboratory resources.
