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1.
Bioanalysis ; 8(6): 487-95, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26916197

RESUMO

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.


Assuntos
Biomarcadores/análise , Medicamentos Biossimilares/análise , Avaliação Pré-Clínica de Medicamentos/métodos , Biomarcadores/sangue , Registros Eletrônicos de Saúde , Laboratórios , Sociedades Médicas , Estudos de Validação como Assunto
2.
Bioanalysis ; 6(22): 2957-63, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25496252

RESUMO

The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation--The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.


Assuntos
Técnicas de Química Analítica/normas , Guias como Assunto , Estudos de Validação como Assunto , Biomarcadores/análise , Calibragem , Ligantes , Limite de Detecção , Kit de Reagentes para Diagnóstico , Reprodutibilidade dos Testes , Estados Unidos , United States Food and Drug Administration
3.
Bioanalysis ; 6(18): 2385-90, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25384591

RESUMO

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.


Assuntos
Testes de Química Clínica , Coleta de Dados , Reprodutibilidade dos Testes
5.
AAPS J ; 16(5): 885-93, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24961918

RESUMO

Consensus practices and regulatory guidance for liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) assays of small molecules are more aligned globally than for any of the other bioanalytical techniques addressed by the Global Bioanalysis Consortium. The three Global Bioanalysis Consortium Harmonization Teams provide recommendations and best practices for areas not yet addressed fully by guidances and consensus for small molecule bioanalysis. Recommendations from all three teams are combined in this report for chromatographic run quality, validation, and sample analysis run acceptance.


Assuntos
Cromatografia Líquida/normas , Espectrometria de Massas em Tandem/normas , Tecnologia Farmacêutica/normas , Benchmarking , Calibragem , Consenso , Controle de Qualidade , Padrões de Referência , Reprodutibilidade dos Testes , Tecnologia Farmacêutica/métodos
8.
Bioanalysis ; 4(17): 2117-26, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23013394

RESUMO

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.


Assuntos
Combinação de Medicamentos , Preparações Farmacêuticas/análise , Tecnologia Farmacêutica/normas , Biomarcadores/análise , Cromatografia Líquida de Alta Pressão/métodos , Estabilidade de Medicamentos , Regulamentação Governamental , Guias como Assunto , Humanos , Espectrometria de Massas em Tandem/métodos
10.
J Pharm Biomed Anal ; 48(5): 1397-403, 2008 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-18996667

RESUMO

Recent studies have shown a correlation between 5-lipoxygenase (5-LO) pathway up-regulation and cardiovascular risk. Despite the existence of several assays for products of the 5-LO pathway, a reliable method for clinical determination of 5-LO activity remains to be established. In the present communication, we report conditions that allow measurement of 5-hydroxyeicosatetraenoic acid (5-HETE) and leukotriene B(4) (LTB(4)) in peripheral blood mononuclear cells (PBMCs) isolated from the blood of atherosclerosis patients before and after stimulation by the calcium ionophore, A23187. LTB(4), a potent mediator of inflammation-linked cardiovascular disease, was measured using an existing competitive enzyme immunoassay (EIA) kit after making specific methodological improvements that allowed PBMCs to be used in this format for the first time. LTB(4) was also measured by LC/MS/MS along with 5-HETE, a direct by-product of the action of 5-LO on arachidonic acid and a molecule for which no commercial EIA kit exists. The LC/MS/MS assay was validated over a range of 0.025-25ng/mL for LTB(4) and 0.1-25ng/mL for 5-HETE. The EIA method has a validated range covering 0.025-4ng/mL. When both assays were applied to analyze LTB(4) from stimulated PBMCs isolated from 25 subjects with various degrees of atherosclerosis, a high correlation was obtained (r=0.9426, Pearson's correlation coefficient). A high correlation was also observed between the levels of LTB(4) and 5-HETE measured by LC/MS/MS after ionophore stimulation (r=0.9159). Details are presented for optimized sample collection, processing, storage, and analysis in accordance with the logistical demands of clinical analysis.


Assuntos
Araquidonato 5-Lipoxigenase/sangue , Araquidonato 5-Lipoxigenase/metabolismo , Técnicas Imunoenzimáticas/métodos , Leucócitos Mononucleares/enzimologia , Araquidonato 5-Lipoxigenase/genética , Calcimicina/metabolismo , Calcimicina/farmacologia , Cromatografia Líquida , Humanos , Ácidos Hidroxieicosatetraenoicos/genética , Ácidos Hidroxieicosatetraenoicos/metabolismo , Ionóforos/metabolismo , Ionóforos/farmacologia , Leucotrieno B4/análise , Leucotrieno B4/genética , Leucotrieno B4/metabolismo , Reprodutibilidade dos Testes , Espectrometria de Massas em Tandem , Temperatura , Fatores de Tempo
11.
J Pharm Biomed Anal ; 38(4): 720-33, 2005 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-15967301

RESUMO

A sensitive and selective liquid chromatography tandem mass spectrometry (LC/MS/MS) method for the determination of atomoxetine and its metabolites (4-hydroxyatomoxetine, N-des-methylatomoxetine, and 4-hydroxyatomoxetine-O-glucuronide) has been developed for human plasma and urine. Using stable-labeled internal standards, the method proved to be accurate and precise for the analytes in all species, resulting in inter-batch accuracy (percent relative error, %RE) within 100+/-13% and inter-batch precision (relative standard deviation, %RSD) within 11%. Stability was demonstrated for the analytes in neat solutions and the reconstitution solvent, as well as plasma and urine (with or without the deconjugation reagent). The method was simple, robust (utilized for the analysis of several hundred clinical study samples), and amenable to high sample throughput.


Assuntos
Propilaminas/análise , Cloridrato de Atomoxetina , Biotransformação , Calibragem , Cromatografia Líquida , Glucuronídeos/sangue , Glucuronídeos/urina , Humanos , Espectrometria de Massas , Oxirredução , Propilaminas/sangue , Propilaminas/urina , Padrões de Referência , Reprodutibilidade dos Testes , Espectrometria de Fluorescência , Espectrofotometria Ultravioleta
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