RESUMO
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.
Assuntos
Descoberta de Drogas/métodos , Animais , Bioquímica/métodos , Bioquímica/normas , Biomarcadores Farmacológicos/análise , California , Técnicas de Química Analítica/métodos , Técnicas de Química Analítica/normas , Aprovação de Drogas/métodos , Descoberta de Drogas/normas , Humanos , Farmacocinética , Estudos de Validação como AssuntoRESUMO
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.
Assuntos
Cromatografia Líquida de Alta Pressão/métodos , Guias como Assunto , Imunoensaio/métodos , Espectrometria de Massas/métodos , Preparações Farmacêuticas/análise , Proteínas Recombinantes/análise , Calibragem , Cromatografia Líquida de Alta Pressão/normas , Teste em Amostras de Sangue Seco/métodos , Indústria Farmacêutica , Regulamentação Governamental , Humanos , Imunoensaio/normas , Espectrometria de Massas/normas , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Estudos de Validação como AssuntoRESUMO
Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.
Assuntos
Equivalência Terapêutica , Aprovação de Drogas/legislação & jurisprudência , Humanos , Farmacocinética , Estados Unidos , United States Food and Drug Administration , Organização Mundial da SaúdeRESUMO
Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.
Assuntos
Aprovação de Drogas/legislação & jurisprudência , Medicamentos Genéricos/farmacocinética , Equivalência Terapêutica , Canadá , Avaliação Pré-Clínica de Medicamentos/métodos , Europa (Continente) , Humanos , Internacionalidade , Estados Unidos , Organização Mundial da SaúdeRESUMO
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.
Assuntos
Preparações Farmacêuticas/análise , Calibragem , Cromatografia Líquida de Alta Pressão/métodos , Cromatografia Líquida de Alta Pressão/normas , Teste em Amostras de Sangue Seco/métodos , Teste em Amostras de Sangue Seco/normas , Indústria Farmacêutica , Regulamentação Governamental , Guias como Assunto , Humanos , Espectrometria de Massas/instrumentação , Espectrometria de Massas/métodos , Espectrometria de Massas/normas , Transferência de Tecnologia , Análise Serial de Tecidos/métodos , Análise Serial de Tecidos/normas , Estudos de Validação como AssuntoRESUMO
The 3rd Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis was organized by the Calibration and Validation Group as a 1.5-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges. A consensus was reached among panelists and attendees on many points regarding method validation of small molecules.
Assuntos
Técnicas de Química Analítica/métodos , Preparações Farmacêuticas/análise , Técnicas de Química Analítica/normas , Humanos , Estudos de Validação como AssuntoRESUMO
The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules.
Assuntos
Biofarmácia/métodos , Técnicas de Química Analítica/métodos , Cooperação Internacional , Preparações Farmacêuticas/análise , Biofarmácia/normas , Calibragem , Técnicas de Química Analítica/normas , Humanos , Preparações Farmacêuticas/normas , Controle de Qualidade , QuebequeRESUMO
This event was organized by the Calibration and Validation Group (a scientific nonprofit organization based in Toronto, Canada) as a 1.5-day workshop for contract research organizations and pharmaceutical companies involved in providing bioanalytical data for bioavailability, bioequivalence, pharmacokinetic and comparability studies.