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1.
Bioanalysis ; 11(18s): 1-228, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31565956

RESUMO

The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.


Assuntos
Biomarcadores/análise , Guias como Assunto , Humanos , Reprodutibilidade dos Testes , Projetos de Pesquisa
2.
Bioanalysis ; 11(12): 1129-1138, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31319683

RESUMO

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. 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: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.


Assuntos
Certificação , Técnicas de Química Analítica , Citometria de Fluxo , Espectrometria de Massas , Oligonucleotídeos/análise , Controle Social Formal , Sociedades Científicas , Indicadores e Reagentes/química
3.
Bioanalysis ; 11(7): 645-653, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30993999

RESUMO

Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC members' opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users.


Assuntos
Bioensaio/métodos , Biomarcadores/análise , Bioensaio/normas , Descoberta de Drogas , Humanos , Ligantes , Preparações Farmacêuticas/química , Preparações Farmacêuticas/metabolismo , Preparações Farmacêuticas/normas , Controle de Qualidade , Kit de Reagentes para Diagnóstico , Padrões de Referência , Sociedades Farmacêuticas , Inquéritos e Questionários
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