Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug management

Matrix effect and recovery terminology issues in regulated drug bioanalysis

(2012) Yong Huang et al.   Bioanalysis

Conference Report: US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical Consortium

(2012) Fabio Garofolo et al.   Bioanalysis

Microanalysis of the antiretroviral nevirapine in human hair from HIV-infected patients by liquid chromatography-tandem mass spectrometry

(2011) Yong Huang et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Adherence to HIV Therapeutic Drug Monitoring Guidelines in The Netherlands

(2011) Matthijs van Luin et al.   THERAPEUTIC DRUG MONITORING

Historical perspective on the development and evolution of bioanalytical guidance and technology

(2011) Vinod P Shah et al.   Bioanalysis

Identifying trends and developing solutions for incurred sample reanalysis failure investigations in a bioanalytical CRO

(2011) Min Meng et al.   Bioanalysis

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

(2011) Fabio Garofolo et al.   Bioanalysis

Incurred sample reanalysis (ISR): a decisive tool in bioanalytical research

(2011) Manish Yadav et al.   Bioanalysis

Therapeutic drug monitoring by LC–MS–MS with special focus on anti-infective drugs

(2010) Daniel M. Müller et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Advances in validation, risk and uncertainty assessment of bioanalytical methods

(2010) E. Rozet et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

International harmonization of bioanalytical guidance

(2010) Surendra K Bansal et al.   Bioanalysis

Building the Global Bioanalysis Consortium – working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation

(2010) Peter van Amsterdam et al.   Bioanalysis

Statistical Considerations for Assessment of Bioanalytical Incurred Sample Reproducibility

(2009) David Hoffman   AAPS Journal

Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

(2009) Douglas M. Fast et al.   AAPS Journal

A proposed “fixed” range decision criteria for transfer of bioanalytical methods

(2009) Kumar A. Shah et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation

(2009) Bruno Boulanger et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Dried Blood Spot Methods in Therapeutic Drug Monitoring: Methods, Assays, and Pitfalls

(2009) Peter M Edelbroek et al.   THERAPEUTIC DRUG MONITORING

Validation of a Liquid Chromatography-Mass Spectrometric Assay for Tacrolimus in Peripheral Blood Mononuclear Cells

(2009) Arnaud Capron et al.   THERAPEUTIC DRUG MONITORING

The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis

(2009) Natasha Savoie et al.   Bioanalysis

Development of bioanalysis: a short history

(2009) Howard Hill   Bioanalysis

2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

(2009) Natasha Savoie et al.   Bioanalysis

Measurement of xenobiotics in saliva: is saliva an attractive alternative matrix? Case studies and analytical perspectives

(2008) Ramesh Mullangi et al.   BIOMEDICAL CHROMATOGRAPHY

Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories

(2008) Giuseppe Lippi et al.   CLINICAL CHEMISTRY AND LABORATORY MEDICINE

Development and validation of a LC/MS/MS method for quantifying the next generation calcineurin inhibitor, voclosporin, in human whole blood

(2008) R HANDY et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Sensitive analysis of anti-HIV drugs, efavirenz, lopinavir and ritonavir, in human hair by liquid chromatography coupled with tandem mass spectrometry

(2008) Yong Huang et al.   RAPID COMMUNICATIONS IN MASS SPECTROMETRY

Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories

(2007) J. Ezzelle et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS