RESUMEN
Biomarker assays have brought significant challenges to bioanalytical laboratories that historically have provided pharmacokinetic analytical services to the drug development industry. This has largely been due to two reasons: the lack of regulatory guidance in how to validate biomarker assays and the lack of scientists in bioanalytical laboratories with experience in this clinical arena. Since biomarkers have been measured for many decades in clinical laboratories globally, this article reviews the different types of analytical laboratories and their practices and case studies will demonstrate the potential outcomes of using biomarker assays in drug development when they are not validated correctly.
Asunto(s)
Bioensayo/normas , Servicios de Laboratorio Clínico , Proyectos de Investigación , Estudios de Validación como Asunto , Biomarcadores/análisis , Calibración , Descubrimiento de Drogas , Guías como Asunto , Humanos , Laboratorios , Control de Calidad , Estándares de Referencia , Reproducibilidad de los Resultados , Sensibilidad y EspecificidadRESUMEN
As part of this themed issue, Bioanalysis invited a selection of researchers to express their views on method transfer in the bioanalytical field. The topics discussed include the main challenges in method transfer, the importance of communication and approaches for assessing the acceptability of transfers. Their responses provide a valuable insight into the considerations that need to be taken into account for successful method transfer.
Asunto(s)
Técnicas de Química Analítica , Laboratorios , Biomarcadores/análisis , Comunicación , Congelación , Humanos , Laboratorios/normas , Control de Calidad , Estándares de Referencia , Reproducibilidad de los Resultados , Control Social Formal , Transferencia de TecnologíaRESUMEN
Bioanalysis invited a selection of leading researchers to express their views on automation in the bioanalytical laboratory. The topics discussed include the challenges that the modern bioanalyst faces when integrating automation into existing drug-development processes, the impact of automation and how they envision the modern bioanalytical laboratory changing in the near future. Their enlightening responses provide a valuable insight into the impact of automation and the future of the constantly evolving bioanalytical laboratory.
Asunto(s)
Automatización , Bioensayo/métodos , Descubrimiento de Drogas , LaboratoriosRESUMEN
Laboratory automation is not new, but few scientists have been exposed to the wide range of analytical equipment platforms, which have been available from diagnostic and research companies, with many workers focusing on one or the other disciplines throughout their career. However, many such instrument platforms play an important role in drug-development in laboratories around the world. This review covers some of the experiences I have had in what is nearly 40 years in laboratory analysis - the last 18 years being in CROs supporting pharmaceutical development. There are many platforms that I have used, which are not included here since the focus of the article is on immunoassay techniques. I think it is worthy to note that many of the capabilities within modern platforms, from a wide range of manufacturers, would appear to me to have a 'genetic' link back to the first automated analyzers launched over 50 years ago. It has been interesting to take a walk down the development road of these platforms over that timeframe and, no doubt, will continue to be at least equally of interest in the future.