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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.
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.
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
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
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
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
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-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.