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Scientific Publications
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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.

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J. He, N. Gharavi, and F. Trabelsi. Single-and Multiple-Dose Bioequivalence Studies for Oxycodone Extended Release 80 mg and 5 mg Tablet. Lessons learned at Biopharma Services Inc. Presented at the 2017 AAPS Annual Meeting and Exposition being held Nov 12-15, 2017 in San Diego.

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N. Rayad, N. Gharavi, J. He, F. Trabelsi. Opportunities and Challenges in Clinical Studies of Generic Anticancer Tyrosine Kinase Inhibitors. Presented at the 2017 AAPS Annual Meeting and Exposition being held Nov 12-15, 2017 in San Diego.

R. Chandani, J. He, F. Trabelsi. Atypical pharmacokinetic profiles observed with Dasatinib reference listed drug product in bioequivalence studies. Presented at the AAPS Annual Meeting, San Diego (November 2017).

 

J. He, N. Gharavi, and F. Trabelsi. Single-and Multiple-Dose Bioequivalence Studies for Oxycodone Extended Release 80 mg and 5 mg Tablet – Lessons learned at Biopharma Services Inc. Presented at the AAPS Annual Meeting, San Diego (November 2017).

 

N. Rayad, N. Gharavi, J. He, F. Trabelsi. Opportunities and Challenges in Clinical Studies of Generic Anticancer Tyrosine Kinase Inhibitors. Presented at the AAPS Annual Meeting, San Diego (November 2017)

 

R. Chandani, J. He, F. Trabelsi. An Effective Approach to Assess Bioequivalence of Fingolimod in Normal Healthy Volunteers using 0.5 mg Study Dose. Presented at the AAPS Annual Meeting, Denver (November 2016).

 

J. He, N. Gharavi, H. Somasundaram, U. Patel, R. Chandani, F. Trabelsi. Safe and Effective Design of Bioequivalence Study of 400 mg of Imatinib in Normal Healthy Volunteers under Both Fasting and Fed Conditions: A Biopharma Services Inc. Perspective. Presented at the 2016 AAPS Annual Meeting and Exposition being held Nov 13-17, 2016 in Denver.

 

F. Trabelsi, N. Gharavi, Y. Ding, P. Pequeno, Juan He. Sample Size Estimation and Passing Rate Analysis for Highly Variable Drugs using FDA’s Scaled Average Bioequivalence Approach. Presented at the AAPS Annual Meeting, Orlando (October 2015).

 

J. He, Y.Ding, R. Chandani and F. Trabelsi. Challenge with New FDA Requirement for Partial AUCs for Bioequivalence Assessment of Modified-Release Products. Presented at the AAPS Annual Meeting, Orlando (October 2015).

 

J. Kumar Patel, P. Hang, K. Awaiye, F. Trabelsi. LCMS/MS method of Fingolimod in human whole blood – Is sensitivity and required blood volume an issue? Presented at the AAPS Annual Meeting, Orlando (October 2015).

 

Y. Ding, J. He, P. Pequeno, F. Trabelsi. Sample Size Needed to Demonstrate Bioequivalence for Narrow Therapeutic Index Drugs: Modeling Based Method. Presented at the AAPS Annual Meeting, San Diego (November 2014).

 

A. Tan, T. Saffaj, A. Musuku, K. Awaiye, B. Ihssane, F. Jhilal, S. Alaoui Sosse, F. Trabelsi. Large-Scale Retrospective Evaluation of Regulated Liquid Chromatography-Mass Spectrometry Bioanalysis Projects Using Different Total Error Approaches. Presented at ASMS Conference, Baltimore (June 2014).

 

A. Tan, K. Awaiye, F. Trabelsi. New quadratic calibration approaches for LC-MS bioanalysis: Impact of calibrator concentrations and their distribution on accuracy of quadratic regression. Presented at the ASMS Conference, Minneapolis (June 2013).

 

Z. Tayab, F. Trabelsi, J. He. Nonparametric Superposition to Predict Ropinirole Pharmacokinetics Data at Steady-state using Single-dose Data. Presented at the AAPS Annual Meeting, Chicago (October 2012).

 

A. Tan, P. Hang, J. Kumar Patel, K. Awaiye, and F. Trabelsi. An alternative approach to time-consuming plasma stripping for endogenous compounds: Application to progesterone determination by LC/MS/MS. Presented at the AAPS Annual Meeting, Chicago (October 2012).

 

A. Tan, K. Awaiye, B. Jose, L. Lutter, F. Trabelsi. LC/MS/MS without chromatographic separation: High throughput simultaneous determination of valsartan and hydrochlorothiazide in human plasma using LC/MS/MS. Presented at the AAPS Annual Meeting, Chicago (October 2012).

 

J. He, M. Bhatti, and L. Lutter. The investigation of variability of the pharmacokinetics of mesalamine from various mesalamine formulations in randomized clinical trials. Presented at the CSPS Annual Conference, Toronto (June 2011).

 

J. He, M. Bhatti, L. Lutter. Clinical Study Program for 505(b)(2) NDA Application – The Fast Path to Approval. Presented at the CSPS Annual Conference, Toronto (June 2009).

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).

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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).

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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.

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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

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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).

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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

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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.

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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.

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Publication year: 2009

 

Hughes NC, Wong EY, Fan J, Bajaj N. Determination of carryover and contamination for mass spectrometry- based chromatographic assays.

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Publication year: 2007

 

Washington C, Hou SY, Hughes N, Campanella C, Berner B. Ciprofloxacin prolonged-release tablets do not affect warfarin pharmacokinetics and pharmacodynamics.

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Publication year: 2007

 

Washington C, Hou E, Hughes N, Berner B. Effect of omeprazole on bioavailability of an oral extended- release formulation of ciprofloxacin.

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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.

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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.

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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.

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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.

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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.

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Publication year: 2001