Intertek Pharmaceutical Bioanalysis Publications
Learn more from Intertek's experts by reviewing our pharmaceutical journal and industry publications
- Drug Tolerance Assessment and Improvement in Cell Based NAb Assays Using Response Data Modeling.
A. Nikolskaya, N. Ibrahim, F. Hosseini, N. Prigozhina, Intertek Pharmaceutical Services, San Diego, CA, USA. Poster presentation at the AAPS Annual Meeting and Exposition, November 12 – 15, 2017.
- Use of LC-HRMS for Protein Analysis in Drug Development. Laurence M. Brill, Intertek Pharmaceutical Services, San Diego, CA, USA. Presentation at the AAPS Annual Meeting and Exposition, November 12 – 15, 2017.
- Drug Tolerance Improvement in Cell Based Neutralizing Antibody Assays Using Pharmacokinetic Assay Data. A. Nikolskaya, N. Ibrahim, F. Hosseini, N. Prigozhina, Intertek Pharmaceutical Services, San Diego, CA, USA. Poster presentation at the Immunogenicity and Bioassay Summit, October 24 – 27, 2017.
- Development and Validation of Bioanalytical Methods in Ocular Matrices.
Mike Buonarati, PhD, Senior Director, Intertek Pharmaceutical Services, San Diego, CA, USA. Presentation at the Applied Pharmaceutical Analysis (APA) Annual Meeting, September 18 - 20, 2017.
- Feasibility of a 3D Spheroid Model System for Dynamic and End-Point Drug Testing Readouts.
Natalie Prigozhina, PhD, Principal Investigator, Cell Based Assays, Intertek Pharmaceutical Services, San Diego, CA, USA. Poster presentation at the Applied Pharmaceutical Analysis (APA) Annual Meeting, September 18 – 20, 2017.
- Versatile Enzyme Activity Assay of a PEGylated Cyst(e)inase in Mammalian Sera Using LC-MS/MS. Laurence M. Brill, PhD, Senior Scientist, Bioanalytical LCMS, Intertek Pharmaceutical Services, San Diego, CA, USA. Poster presentation at the ASMS Annual Conference, June 4 – 8, 2017.
- Challenges in Developing Ocular Drugs from a Bioanalytical and Toxicological Perspective. Mike Buonarati, Senior Director, Bioanalytical LCMS, Intertek Pharmaceutical Services, San Diego, CA, USA; Lindsay N. Donald, DABT, Vice President, Pharmaceutical & Healthcare, Intertek Scientific & Regulatory Consultancy, Birmingham, AL, USA. Presentation at the SOT Annual Meeting and ToxExpo, March 12 – 16, 2017.
- Total Unbound Cysteine/Cystine Assay in Monkey Plasma Using LC-MS/MS.
L. Brill, M. Buonarati, and D. Schoener, Intertek Pharmaceutical Services, San Diego, CA, USA; Susan Alters, Aeglea Biotherapeutics, Austin, TX, USA; Everett Stone, University of Texas at Austin, Austin, TX, USA. Poster presentation at the MSACL Annual Conference, January 22 – 26, 2017.
- LCMS Advanced Small Molecules Method Development and Case Studies: Challenges, Solutions, and Industry Standards Course Outline. Lesson 01: 'Method development of Special biological fluids: Ocular Fluids & Ocular Tissues' Dr. Mike Buonarati, Senior Director, Intertek Pharmaceutical Services, 2016
- Conference Report: 9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks. Wei Garofolo, Sarah Harris, Manju Saxena, Mike Buonarati, et al. Bioanalysis Vol. 8, No. 6, Pages 487-495, March 2016
- A Novel Validated Method for the Determination of Cyclosporine in Rabbit Ocular Tissues by LC-MS/MS Lee Hamm, James Atwood, Melanie Gee-Shihabi, Michael Buonarati, Poonam Velagaleti. Poster presentation at the 63rd ASMS Conference on Mass Spectrometry, June 2015
- Challenges and Approaches in Biomarker Assays for Mitigating Variability with Improved Accuracy and Precision. M. Saxena, J.E. Weant, A.J. Westergren, W.O. Cabanes and M.D. Losauro, Intertek Pharmaceutical Services, San Diego, CA, USA. Poster presentation at the 2015 AAPS Annual Meeting and Exposition, October 26–29, 2015
- Enzyme Activity Assay of a PEGylated Arginase in Serum Using LC-MS/MS. Oanh Dang, Susan Alters, Scott Rowlinson, Everett Stone, John Bruce, Shannon Bryant, Mike Buonarati, Dale Schoener. Poster presentation at the ASMS Annual Conference 2015, June 2015
- General Protein Analysis using in-source CID and SEC Chromatography. Dale Schoener, John Cremin, Michael Buonarati, Intertek Pharmaceutical Services, El Dorado Hills, CA. Poster presentation at the ASMS Annual Conference 2015, June 2015
- eBook, Future Science, Bioanalysis for Biosimilars Development Editor: Paul Declerck (University of Leuven) Chapter 4: Analytical Comparability (chemistry, manufacturing and controls related product attributes); Ashleigh Wake, Biotechnology Program Manager, Intertek Pharmaceutical Services, Manchester, UK
- Conference Report. 8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation Wei Garofolo, Mike Buonarati, et al. Bioanalysis, November 2014, Vol. 6, No. 22, Pages 2957-2963
- Research Article: LC–MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column, Janice Pursley, Jim X Shen, Alan Schuster, Oanh T Dang, Jim Lehman, Michael H Buonarati, Yan Song, Anne-Francoise Aubry and Mark E Arnold. Bionalysis, August 2014 ,Vol. 6, No. 15, Pages 2071-2082
- Commentary, 7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing. Wei Garofolo, Mike Buonarati, et al. Bioanalysis, Vol. 6, No. 20, Pages 2713-2720, October 2014
- White Paper: Recommendations on incurred sample stability (ISS) by GCCWei Garofolo, Mike Buonarati, et al, Bioanalysis. Vol. 6, No. 18, Pages 2385-2390, September 2014
- 2013 GCC White Paper. Mike Buonarati, Dominique Gouty et al - In Press
- Critical reagent stability for immunogenicity assays, Arron SL Xu & Jessica Weant, Immunogenicity Assay Development, Validation and Implementation, November 2013, Pages 92-104
- 2013 7th Workshop on Recent Issues in Bioanalysis White Paper on Recent Issues in Bioanalysis 2013: ‘hybrid’ – the best of LBA and LCMS. Laura Wright, Mike Losauro, Dominique Gouty et al. Bioanalysis 2013
- Antibody Drug Conjugate Drug Development: Where Are the Challenges? Laura Wright, Sharon Baughman, and Ashleigh Wake. Bioanalysis, Vol. 5, No. 12, Pages 1467-1469, June 2013
- Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development Cai XY, Wake A, Gouty D. Bioanalysis, Vol. 5, No. 5, Pages 517-520, March 2013
- Recommendations on biomarker bioanalytical method validation by GCC. Hougton R, Gouty D, et al. Bioanalysis. Oct Vol 4, No 20, pages 2439-2446, 2012
- Conference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars. Nicholson R, et al., Gouty D, Bioanalysis. Oct, Vol 4, No.19, Pages 2335-2442, 2012
- 2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines Bioanalysis, , Vol. 4, No. 18, Pages 2213-2226, September 2012
- Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC), Lowes S, et al., Gouty D, Vol. 4, No. 17, Pages 2117-2126, September 2012
- Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development. Cai XY, Thomas J, Cullen C, Gouty D. Bioanalysis, vol.4, No.17, Pages 2169-2177, September 2012
- Biosimilars - Biosimilar Drugs Test the Limits of Statistical Quality Control PFQ, August/September 2012
- Recommendations and Requirements for the Design of Bioanalytical Testing Used in Comparability Studies for Biosimilar Drug Development Bioanalysis, Volume 3, Issue 5, pp. 535-540
- 2011 White Paper on Recent Issues in Bioanalysis & Regulatory Findings from Audits and Inspections. Garofolo F , Rossi M, Dumont I, Martinez S, Lowes S, Woolf E, Booth B, DeSilva B, Dunn J, Gouty D, Hucker R, Lee J, Weiner R, Bioanalysis June Sep 2011, Vol. 3, No. 18, Pages 2081-2096
- Recommendations and requirements for the design of bioanalytical testing used in comparability studies for Biosimilar drug development. Cai, X., Gouty D, Baughman S, Ramakrishnan M, Cullen C. Bioanalysis, March 2011, Vol.3, No. 5, 535-540
- FDA to Approve New Generics, but Healthcare Savings Will be Minimal, Scientific American, December 2011
- Applied Pharmaceutical Analysis 2010 Quantitation of the Synthetic Prostacyclin Beraprost, Total Beraprost and the Active 314d Stereoisomer
- Formation of a Global Contract Research Organization Council for Bioanalysis. Formation of a Global Contract Research Organization Council for Bioanalysis.Noel Premkumar, Stephen Lowes, Mike Buonarati, Dominique Gouty et al. Bioanalysis, Vol 2, No.11 Pages 1798-1800, 2010
- AAPS 2010 Analysis of Non-Encapsulated and Liposome Encapsulated Vincristine in Human Plasma, Phua Penney, Jeffrey Silverman, Michael Buonarati, Dale Schoener. Poster presentation
- ASMS-2010 Analysis and Stabilization of MTIC, the Biologically Active Hydrolysis Product of the Antitumor Pro-Drug Temozolomide, in Plasma and Whole Blood
- 4TH Workshop in Regulated Bioanalysis, April-2010 Comparison of 1/x2 & 1/x weighting for Standard Curves of Pharmaceutical PK/TK Data
- ASMS-2009 LL Extraction along with Colloidal Silica and Polyvalent Cations to Remove Phospholipids
- ASMS-2009 HPLC/MS/MS with In-Source Collision Induced Dissociation for Direct Measurement of PEGylated Compounds in Biological Matrices
- ASMS-2008 LC-MS/MS Assay Development and Validation for Determination of Total Doxorubicin (Free + Liposomal) in Human Plasma and Clinical Sample Analysis, Ron Huang, Aldo Costa, Mike Buonarati, Dale Schoener, Seema Datta, Joseph Whitson and Liyu Yang. Poster presentation.
- ASMS-2008 Enhanced LC/MS Detection of a Benzoxaborole by Derivatization with (+) Pinanediol
- ASMS-2008 Automated Screening System for Solvent and Column Selections to Minimize Carryover
- FDA Bioanalytical Guidance 2001
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