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Scientific Publications

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. 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. 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.

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

 

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