Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification …

O González, ME Blanco, G Iriarte, L Bartolomé… - … of Chromatography A, 2014 - Elsevier
Method validation is a mandatory step in bioanalysis, to evaluate the ability of developed
methods in providing reliable results for their routine application. Even if some organisations …

[HTML][HTML] Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?

M Kaza, M Karaźniewicz-Łada, K Kosicka… - … of pharmaceutical and …, 2019 - Elsevier
Bioanalysis concerns the identification and quantification of analytes in various biological
matrices. Validation of any analytical method helps to achieve reliable results that are …

Advances in validation, risk and uncertainty assessment of bioanalytical methods

E Rozet, RD Marini, E Ziemons, B Boulanger… - … of pharmaceutical and …, 2011 - Elsevier
Bioanalytical method validation is a mandatory step to evaluate the ability of developed
methods to provide accurate results for their routine application in order to trust the critical …

Workshop report and follow-up—AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples—implications of Crystal City …

DM Fast, M Kelley, CT Viswanathan, J O'Shaughnessy… - The AAPS journal, 2009 - Springer
Abstract The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City
III) endorsed the concept that assay methods supporting bioanalytical data in submissions …

Recommendations for the validation of flow cytometric testing during drug development: II assays

DM O'Hara, Y Xu, Z Liang, MP Reddy, DY Wu… - Journal of …, 2011 - Elsevier
Flow cytometry-based assays serve as valuable tools for various aspects of the drug
development process ranging from target discovery and characterization to evaluation of …

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

M Yadav, PS Shrivastav - Bioanalysis, 2011 - Taylor & Francis
The AAPS Workshop 2008 on Current Topics in GLP Bioanalysis: Assay Reproducibility for
Incurred Samples was the defining moment in establishing incurred sample reanalysis (ISR) …

Validation of bioanalytical chromatographic methods for the quantification of drugs in biological fluids

O González, RM Alonso - Handbook of analytical separations, 2020 - Elsevier
Method validation is a mandatory step in bioanalysis to evaluate the ability of developed
methods in providing reliable results for their routine application. Even if some organisations …

Validated UPLC–MS/MS method for determination of hordenine in rat plasma and its application to pharmacokinetic study

J Ma, S Wang, X Huang, P Geng, C Wen, Y Zhou… - … of Pharmaceutical and …, 2015 - Elsevier
Hordenine is an active compound found in several foods, herbs and beer. In this work, a
sensitive and selective UPLC–MS/MS method for determination of hordenine in rat plasma …

An accurate, rapid and sensitive determination of tramadol and its active metabolite O-desmethyltramadol in human plasma by LC–MS/MS

BN Patel, N Sharma, M Sanyal… - Journal of pharmaceutical …, 2009 - Elsevier
A rapid, sensitive and accurate liquid chromatography–tandem mass spectrometry (LC–
MS/MS) assay for the simultaneous determination of tramadol and its active metabolite, O …

The 2nd calibration and validation group workshop on recent issues in good laboratory practice bioanalysis

N Savoie, BP Booth, T Bradley, F Garofolo… - Bioanalysis, 2009 - Taylor & Francis
This event was organized by the Calibration and Validation Group (a scientific nonprofit
organization based in Toronto, Canada) as a 1.5-day workshop for contract research …