J. Smeraglia

发表

Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Rebecca M Crisino, S. Dudal, D. Baltrukonis, 2013, The AAPS Journal.

A pharmacokinetic study of radiprodil oral suspension in healthy adults comparing conventional venous blood sampling with two microsampling techniques

J. Smeraglia, C. Otoul, D. Sciberras, 2019, Pharmacology research & perspectives.

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).

Sam H Haidar, Lauren F. Stevenson, Barry van der Strate, 2017, Bioanalysis.

Conference Report: the 3rd EBF Focus Meeting: 'Hatching'--emerging technologies approaching the regulated bioanalysis laboratory. Brussels, Belgium, 12-13 June 2012.

P. Timmerman, Neil Henderson, A. Companjen, 2012, Bioanalysis.

EBF recommendation on the validation of bioanalytical methods for dried blood spots.

P. Timmerman, Steve White, J. Smeraglia, 2011, Bioanalysis.

Best practices for metabolite quantification in drug development: updated recommendation from the European Bioanalysis Forum.

P. Timmerman, S. Mcdougall, Steve White, 2016, Bioanalysis.

Reliable and Scalable SARS-CoV-2 qPCR Testing at a High Sample Throughput: Lessons Learned from the Belgian Initiative

S. van Vooren, J. Vandesompele, J. Hellemans, 2022, Life.

Evaluating Diagnostic Accuracy of Saliva Sampling Methods for Severe Acute Respiratory Syndrome Coronavirus 2 Reveals Differential Sensitivity and Association with Viral Load

J. Vandesompele, J. Hellemans, E. André, 2021, The Journal of Molecular Diagnostics.

Effect of rifampin on the pharmacokinetics of SU11248 in healthy volunteers

B. Houk, S. Misbah, J. Smeraglia, 2005 .

Analysis of circulating biomarkers of sunitinib malate in patients with unresectable neuroendocrine tumors (NET): VEGF, IL-8, and soluble VEGF receptors 2 and 3.

L. Tye, H. Lenz, C. Baum, 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Feedback from the EBF - Focus Workshop: bringing assay validation and analysis of biomarkers into practice.

P. Timmerman, B. Barroso, Ulrich Kunz, 2017, Bioanalysis.

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).

Sam H Haidar, Gustavo Mendes Lima Santos, Sam H. Haidar, 2016, Bioanalysis.

Improving the sensitivity and specificity of a bioanalytical assay for the measurement of certolizumab pegol.

J. Smeraglia, John-Paul Silva, K. Jones, 2017, Bioanalysis.

Managing scientific, technical and regulatory innovation in regulated bioanalysis: a discussion paper from the European Bioanalysis Forum.

P. Timmerman, Neil Henderson, A. Companjen, 2013, Bioanalysis.

Managing scientific , technical and regulatory innovation in regulated bioana lysis : a discussion

P. Timmerman, Neil Henderson, A. Companjen, 2022 .

Circulating protein biomarkers of pharmacodynamic activity of sunitinib in patients with metastatic renal cell carcinoma: modulation of VEGF and VEGF-related proteins

John Smeraglia, R. Motzer, M. Michaelson, 2007, Journal of Translational Medicine.

Matrix effects and selectivity issues in LC-MS-MS

J. Smeraglia, D. Watson, S. Baldrey, 2002 .

Connecting strategies on dried blood spots.

P. Timmerman, Steve White, Elizabeth Thomas, 2010, Bioanalysis.

Simple and rapid quantification of cetirizine, venlafaxine, and O-desmethylvenlafaxine in human breast milk, and metformin in human milk and plasma with UHPLC-MS/MS.

C. Wegler, J. Smeraglia, H. Nordeng, 2022, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Pharmacokinetics of sunitinib malate in subjects with hepatic impairment

J. Smeraglia, L. Sherman, M. Toh, 2010, Cancer Chemotherapy and Pharmacology.

Conference report: Discussion on harmonization and globalization of bioanalytical guidances at the 19th International Reid Bioanalytical Forum.

J. Smeraglia, F. Garofolo, M. Seymour, 2011, Bioanalysis.

Tiered approach into practice: scientific validation for chromatography-based assays in early development - a recommendation from the European Bioanalysis Forum.

Magnus Knutsson, Stuart McDougall, Philip Timmerman, 2015, Bioanalysis.

Effect of food on the pharmacokinetics of sunitinib malate (SU11248), a multi-targeted receptor tyrosine kinase inhibitor: results from a phase I study in healthy subjects

John Smeraglia, J. Smeraglia, L. Sherman, 2006, Anti-cancer drugs.

Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Rebecca M Crisino, S. Dudal, D. Baltrukonis, 2013, AAPS Journal.

Evaluation of saliva sampling procedures for SARS-CoV-2 diagnostics reveals differential sensitivity and association with viral load

J. Vandesompele, J. Hellemans, E. André, 2020, medRxiv.

A phase I mass-balance study to evaluate the metabolism and excretion of [14C]-sunitinib (SU11248) in healthy male subjects

J. Smeraglia, L. Sherman, M. Garrett, 2007 .

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).

Renuka Pillutla, Viswanath Devanarayan, An Song, 2015, Bioanalysis.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

Lindsay King, Stacy Ho, Roger Hayes, 2014, Bioanalysis.

Species distribution and antimicrobial susceptibility of gram-negative aerobic bacteria in hospitalized cancer patients

R. Motzer, M. Michaelson, B. Rini, 2009, Journal of Translational Medicine.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

Lindsay King, Roger Hayes, Surinder Kaur, 2014, Bioanalysis.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).

Li Xue, Stacy Ho, Neil Spooner, 2014, Bioanalysis.

Feedback from the European Bioanalysis Forum Workshop: taking tiered approach to the next level.

Magnus Knutsson, Stuart McDougall, Philip Timmerman, 2014, Bioanalysis.

Effect of treatment with sunitinib malate, a multitargeted tyrosine kinase inhibitor, on circulating plasma levels of VEGF, soluble VEGF receptors 2 and 3, and soluble KIT in patients with metastatic breast cancer.

H. Burstein, M. Collier, C. Baum, 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.