R. Chandani, J. He, F. Trabelsi. Atypical pharmacokinetic profiles observed with dasatinib reference listed drug product in bioequivalence studies. Presented at the 2017 AAPS Annual Meeting and Exposition being held Nov 12-15, 2017 in San Diego.
Scientific Publications
Trabelsi F, Gharavi N, Kalovidouris M, Nikolaidou M. Steady-state Bioequivalence study of two quetiapine prolonged-release 400 mg tablet formulations in healthy male and female subjects under fasting. Int J Clin Pharmacol Ther. 2016,;54:732-742.
Aimin Tan, Taoufiq Saffaj, Adrien Musuku, Kayode Awaiye, Bouchaib Ihssane, Fayçal Jhilal, Saad. Alaoui Sosse, Fethi Trabelsi. Large-Scale Retrospective Evaluation of Regulated Liquid Chromatography-Mass Spectrometry Bioanalysis Projects Using Different Total Error Approaches. Journal of Chromatography B, 983-984 (2015) 68-75.
Tan, Aimin; Awaiye, Kayode and Trabelsi, Fethi. Impact of calibrator concentrations and their distribution on accuracy of quadratic regression for LC-MS Bioanalysis. Anal Chim Acta. (2014) Mar 7; 815: 33-41.doi: 10.1016/j.aca.2014.01.036. Epub 2014 Jan 19.
Musuku A., A. Tan, K. Awaiye, F Trabelsi. Comparison of two-concentration with multi-concentration linear regressions: Retrospective data analysis of multiple regulated LC-MS bioanalytical projects. J. Chromatography B. 934 (2013), 117-123.
AiminTan, Kayode Awaiye, Besy Jose, Paresh Joshi, and Fethi Trabelsi. Comparison of Different Linear Calibration Approaches for LC-MS Bioanalysis. Journal of Chromatography B, 911 (2012), 192-202.
Jan Welink, Yuanxin Xu, Eric Yang, Amanda Wilson, Neil Henderson, Lina Luo, Stephanie Fraser, Uma Kavita, Adrien Musuku, Christopher James, Daniela Fraier, Yan Zhang, Dina Goykhman, Scott Summerfield, Eric Woolf, Tom Verhaeghe, Nicola Hughes, Alexander Behling, Kirk Brown, Alex Bulychev, Michael Buonarati, Elana Cherry, Seongeun (Julia) Cho, Isabelle Cludts, Lieve Dillen, Robert Dodge, Anna Edmison, Fabio Garofolo, Rachel Green, Sam Haidar, Charles Hottenstein, Akiko Ishii-Watabe, Hyun Gyung Jang, Allena Ji, Barry Jones, Sean Kassim, Mark Ma, Gustavo Mendes Lima Santos, Daniel A Norris, Tate Owen, Steven Piccoli, Ragu Ramanathan, Ingo Röhl, Anton I Rosenbaum, Yoshiro Saito, Timothy Sangster, Natasha Savoie, Christopher Stebbins, Jens Sydor, Nico van de Merbel, Daniela Verthelyi, Stephen Vinter & Emma Whale. 2018 White Paper on Recent Issues in Bioanalysis: ‘A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)’ (Part 1 – small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Publisher:
Publication year: 2018
Jan Welink, Eric Yang, Nicola Hughes, Brian Rago, Eric Woolf, Jens Sydor, Laura Coppola, Brad Ackermann, Wenkui Li, Stephen C Alley, Mark Arnold, Isabella Berger, Chad Briscoe, Michael Buonarati, Mark Bustard, Mark Cancilla, Seongeun (Julia) Cho, Jeff Duggan, Daniela Fraier, Fabio Garofolo, Rachel Green, Sam Haidar, Lucinda Hittle, Akiko Ishii-Watabe, Rafiq Islam, Rand Jenkins, Barry Jones, John Kadavil, Sean Kassim, Olga Kavetska, Olivier Le Blaye, Anita Lee, Hanlan Liu, John Mehl, Gustavo Mendes Lima Santos, Adrien Musuku, Ragu Ramanathan, Yoshiro Saito, Natasha Savoie, Scott Summerfield, Sekhar Surapaneni, Matthew Szapacs, Nilufer Tampal, Tom Verhaeghe, Stephen Vinter & Emma Whale. 2017 White Paper on recent issues in bioanalysis: aren’t BMV guidance/ guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers).
Publisher:
Publication year: 2017
Hayes R, R, LeLacheur R, Dumont I, Couerbe P, Safavi A, Islam R, Pattison C, Cape S, Rocci M, Briscoe C, Cojocaru L, Groeber E, Silvestro L, Bravo J, Shoup R, Verville M, Zimmer J, Caturla MC, Khadang A, Bourdage J, Hughes N, Fatmi S, Di Donato L, Sheldon C, Keyhani A, Satterwhite C, Yu M, Fiscella M, Hulse J, Lin ZJ, Garofolo W, Savoie N, Xiao YQ, Kurylak K, Harris S, Saxena M, Buonarati M, Lévesque A, Boudreau N, Lin J, Khan MU, Ray G, Liu Y, Xu A, Soni G, Ward I, Kingsley C, Ritzén H, Tabler E, Nicholson B, Bennett P, van de Merbel N, Karnik S, Bouhajib M, Wieling J, Mulvana D, Ingelse B, Allen M, Malone M, Fang X. 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.
Publisher:
Publication year: 2016
Aimin Tan, Kayode Awaiye and Fethi Trabelsi, Chp 10: Novel Calibration approaches for LC-MS bioanalysis. Advanced LC-MS Applications in Bioanalysis.
Edited by: JeanNicholas Mess, Qin C Ji, Dafang Zhong, Long Yuan, and Annik Bergeron
Publisher:
Publication Date: October, 2015
Ackermann B, Neubert H, Hughes N, Garofolo F, Abberley L, Alley SC, Brown-Augsburger P, Bustard M, Chen LZ, Heinrich J, Katori N, Kaur S, Kirkovsky L, Laterza OF, Le Blaye O, Lévesque A, Santos GM, Olah T, Savoie N, Skelly M, Spitz S, Szapacs M, Tampal N, Wang J, Welink J, Wieling J, Haidar S, Vinter S, Whale E, Witte B. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 – hybrid LBA/LCMS and input from regulatory
agencies).
Publisher:
Publication Year: 2015
Welink J, Fluhler E, Hughes N, Arnold M, Garofolo F, Bustard M, Coppola L, Dhodda R, Evans C, Gleason C, Haidar S, Hayes R, Heinig K, Katori N, Blaye OL, Li W, Liu G, Lima Santos GM, Meng M, Nicholson B, Savoie N, Skelly M, Sojo L, Tampal N, van de Merbel N, Verhaeghe T, Vinter S, Wickremsinhe E, Whale E, Wilson A, Witte B, Woolf E. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 – small molecules by LCMS). Publication year: 2015
Publisher:
Publication Year: 2015
Aimin Tan and Kayode Awaiye, Chp 17: Use of Internal Standard in LC-MS
Handbook of Bioanalysis, Best Practices, Experimental Protocols and Regulations.
Edited by: Wenkui Li, Jie Zhang and Francis LS Tse
Publisher:John Wiley
Publication Date: October, 2013
Hughes NC, Bajaj N, Fan J, Wong E. Assessing matrix effects of hemolysed samples in bioanalysis.
Publisher:
Publication year: 2009
Savoie M, Booth RP, Bradly T, Garofolo F, Hughes NC, Hussain S, King, SP, Lindsay M, Lowes S, Ormsby, E, Phull R, Rocci ML, Jr. Vallano PT, Viao A, Zhu Z. The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice Bioanalysis.
Publisher:
Publication year: 2009
Hughes NC, Wong EY, Fan J, Bajaj N. Determination of carryover and contamination for mass spectrometry- based chromatographic assays.
Publisher:
Publication year: 2007
Washington C, Hou SY, Hughes N, Campanella C, Berner B. Ciprofloxacin prolonged-release tablets do not affect warfarin pharmacokinetics and pharmacodynamics.
Publisher:
Publication year: 2007
Washington C, Hou E, Hughes N, Berner B. Effect of omeprazole on bioavailability of an oral extended- release formulation of ciprofloxacin.
Publisher:
Publication year: 2006
Washington CB, Hou SY, Campanella C, Hughes N, Brown B, Berner B. Pharmacokinetics and pharmacodynamics of a novel extended-release ciprofloxacin in healthy volunteers.
Publisher:
Publication year: 2005
Hughes N, Winnik W, Dunyach JJ, Amad M, Splendore M, Paul G. High-sensitivity quantitation of cabergoline and pergolide using a triple quadrupole mass spectrometer with enhanced mass- resolution capabilities.
Publisher:
Publication year: 2003
Paul G, Winnik W, Hughes N, Schweingruber H, Heller R, Schoen A. Accurate mass measurement at enhanced mass-resolution on a triple quadrupole mass-spectrometer for the identification of a reaction impurity and collisionally-induced fragment ions of cabergoline.
Publisher:
Publication year: 2003
Hughes NC, Vaziri SA, Sampson H, Darlington G, Jewett MA, Grant DM. Interindividual variation in cytochrome P4501A2 and the N-acetyltransferases NAT1 and NAT2 is not associated with altered risk for bladder cancer in humans.
Publisher:
Publication year: 2001
Vaziri SA, Hughes NC, Sampson H, Darlington G, Jewett MA, Grant DM. Variation in enzymes of arylamine procarcinogen biotransformation among bladder cancer patients and control subjects.
Publisher:
Publication year: 2001
©2018 BioPharma Services Inc.