RESUMO
The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation. Conclusions and consensus from discussions of these topics are included in this article.
Assuntos
Biomarcadores , Citometria de Fluxo , Citometria de Fluxo/normas , Citometria de Fluxo/métodos , Biomarcadores/análise , Humanos , Sequenciamento de Nucleotídeos em Larga Escala , Reação em Cadeia da Polimerase em Tempo Real/métodosRESUMO
Welcome to volume 12 of Bioanalysis. We want to take this opportunity to wish you all a Happy New Year. As we step into another year of the journal, we would like to reflect on the last year, which was an important milestone for the journal having reached its tenth anniversary. We want to thank all our authors, readers and reviewers, as well as our Editorial Board members for their continued support. We very much look forward to working with everyone in 2020.
Assuntos
Editoração/estatística & dados numéricos , Políticas EditoriaisAssuntos
Desenvolvimento de Medicamentos/organização & administração , Indústria Farmacêutica/organização & administração , Laboratórios/organização & administração , Serviços Terceirizados/organização & administração , Inquéritos e Questionários , Bioensaio/economia , Desenvolvimento de Medicamentos/economia , Indústria Farmacêutica/economia , Laboratórios/economia , Serviços Terceirizados/economia , Inquéritos e Questionários/economiaRESUMO
Welcome to volume 9 of Bioanalysis and Happy New Year to all of our readers. We would like to take the opportunity to look back 2016, which was another great year for us. We thank all our authors, readers and reviewers, as well as our Editorial Board members for their continued support. We very much look forward to working with everyone in 2017.