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As patients seek treatment for low testosterone, it is important for primary care providers to understand the risks and benefits of the therapy and the off-label promotions of its advocates.
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The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the seventh annual Workshop on Recent Issues in Bioanalysis (WRIB) held in Long Beach, CA, USA, in April 2013, and at the Global CRO Council for Bioanalysis (GCC) meeting preceding it. Discussion at both events focused on the use of incurred samples for ISS purposes in light of results from a recent GCC survey completed by member companies. This paper reports the consensus resulting from these discussions and serves as a useful reference for depicting ISS issues and concerns, summarizing the GCC survey results and providing helpful recommendations on ISS in the context of bioanalytical method development and application.
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Pruebas de Química Clínica , Recolección de Datos , Reproducibilidad de los ResultadosRESUMEN
The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science. Such as the previous editions, this 2013 White Paper addresses important bioanalytical issues and provides practical answers to the topics presented, discussed and agreed upon by the global bioanalytical community attending the 7th Workshop on Recent Issues in Bioanalysis.
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Descubrimiento de Drogas/métodos , Animales , Bioquímica/métodos , Bioquímica/normas , Biomarcadores Farmacológicos/análisis , California , Técnicas de Química Analítica/métodos , Técnicas de Química Analítica/normas , Aprobación de Drogas/métodos , Descubrimiento de Drogas/normas , Humanos , Farmacocinética , Estudios de Validación como AsuntoAsunto(s)
Biomarcadores/análisis , Biosimilares Farmacéuticos/análisis , Preparaciones Farmacéuticas/análisis , Biosimilares Farmacéuticos/farmacocinética , Biosimilares Farmacéuticos/normas , Cromatografía Líquida de Alta Presión/normas , Industria Farmacéutica , Espectrometría de Masas/normas , Preparaciones Farmacéuticas/normas , Control de Calidad , Estándares de ReferenciaRESUMEN
Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot' topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this year's workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis.
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Cromatografía Líquida de Alta Presión/métodos , Guías como Asunto , Inmunoensayo/métodos , Espectrometría de Masas/métodos , Preparaciones Farmacéuticas/análisis , Proteínas Recombinantes/análisis , Calibración , Cromatografía Líquida de Alta Presión/normas , Pruebas con Sangre Seca/métodos , Industria Farmacéutica , Regulación Gubernamental , Humanos , Inmunoensayo/normas , Espectrometría de Masas/normas , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Estudios de Validación como AsuntoRESUMEN
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.
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Combinación de Medicamentos , Preparaciones Farmacéuticas/análisis , Tecnología Farmacéutica/normas , Biomarcadores/análisis , Cromatografía Líquida de Alta Presión/métodos , Estabilidad de Medicamentos , Regulación Gubernamental , Guías como Asunto , Humanos , Espectrometría de Masas en Tándem/métodosRESUMEN
The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.