Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto/organização & administração , Infecções por Coronavirus , Difusão de Inovações , Acessibilidade aos Serviços de Saúde , Invenções , Pandemias , Pneumonia Viral , Terapias em Estudo , COVID-19 , Ensaios Clínicos como Assunto/legislação & jurisprudência , Controle de Doenças Transmissíveis/legislação & jurisprudência , Controle de Doenças Transmissíveis/métodos , Infecções por Coronavirus/prevenção & controle , França , Órgãos Governamentais/organização & administração , Humanos , Pandemias/prevenção & controle , Segurança do Paciente , Pneumonia Viral/prevenção & controle , Guias de Prática Clínica como Assunto , SARS-CoV-2RESUMO
The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively.
Assuntos
Biomarcadores/química , Biofarmácia/organização & administração , Biotecnologia/organização & administração , História do Século XXI , HumanosRESUMO
The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input. Part 1 (Small molecules bioanalysis using LCMS) was published in the Bioanalysis issue 6(22) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the Bioanalysis issue 6(24).
Assuntos
Técnicas de Laboratório Clínico , Métodos Analíticos de Preparação de Amostras , Cromatografia Líquida , Humanos , Espectrometria de MassasRESUMO
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
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.
