Scientific Corner

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Scientific Publications and Posters

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Simmulation of Missing Time Points in Bioequivalence Studies - BioPharma Services hero image.

J. Kwok, M. Ngoc Le, J. He and J. Oldenhof. A Simulation-based Decision Guide to Evaluate Missing Data in Bioequivalence Studies Presented at the AAPS 2023 Conference (2023).

Oncology Drugs in Clinical Trials with Healthy Populations Hero Image.

D. Yu, S. Le, J. He and J. Oldenhof. Oncology Drugs in Clinical Trials with Healthy Populations: Old Challenges or New Opportunities. Presented at the DIA 2023 Global Annual Meeting (2023).

Cost-effective strategy –An innovative approach assessing the drifting bioavailability of fixed-dose combination formulations image.

T.V. Nguyen, J. Kwok, S. Le, J. He and J. Oldenhof. Cost-effective strategy – An innovative approach assessing the drifting bioavailability of fixed-dose combination formulations. Presented at the AAPS Annual Meeting, Boston (Oct 2022).

STRATEGIC APPROACHES OF UTILIZING BA/BE STUDIES TO OBTAIN APPROVAL image.

J. Kwok, S. Le, J. He & J. Oldenhof. Strategic Approaches Of Utilizing BA/BE Studies To Obtain Approval From Different Regulatory Agencies For Fixed Dose Combination (2022).

Single and Multiple-Dose Bioequivalence Studies for Oxycodone Extended

M. Ngoc Le, J. He and J. Oldenhof. Safety, Tolerability and Pharmacokinetics of Mid and high Dose of Oral Paliperidone in Single-Dose, Bioequivalence Studies in Healthy Volunteers. Presented at the AAPS Annual Meeting (2021).

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).

Papers in Peer Reviewed Journals

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Once-daily Oxycodone prolonged-release tablets are resistant to alcohol-induced dose dumping: results from a randomised trial in healthy volunteers. Journal of Pain, 2019

Rayad N, Wong W et al. Antiviral treatment for treatment-naïve chronic hepatitis B: systematic review and network meta-analysis of randomized controlled trials (August 2019)

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.

Assessment of the abuse potential of the Orexin receptor antagonist, Suvorexant, compared with Zolpidem in a randomized crossover study.Journal of Clinical Psychopharmacology, 36(4):314-323, Aug 2016

Assessment of pharmacokinetic and pharmacodynamics interactions between albumin-fused mutated butyrylcholinesterase and intravenously administered cocaine in recreational cocaine users. Journal of Clinical Psychopharmacology, 35(4):364-366, Aug 2015

Assessment of Pharmacokinetic and Pharmacodynamic interactions between albumin-infused mutated butyrylcholinesterase and intravenously administered cocaine in recreational cocaine users, Journal of Clinical Psychopharmacology (2015), 36(4):314-323

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.

“Differences in the Vitro and In Vivo Pharmacokinetic Profiles of Once-Daily Modified-Release Methylphenidate Formulations in Canada: Examination of Current Bioequivalence Criteria.” Clinical Therapeutics, Apr 2012

Relative abuse potential and safety of a new formulation Oxycodone HCl tablets (Orexta) in non-dependent opioid users. Journal of Opioid Management, 8(5):315, 2012

Assessing subjective and physiologic effects following intranasal administration of a new formulation of immediate-release oxycodone HCI (OxectaTM) tablets in nondependent recreational opioid users. Journal of Opioid Management, Sep 27, 2012

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.

“Intranasal Abuse Potential of an IR Oxycodone Formulations (Poster Presentation).” American Academy of Pain Management 22nd Annual Clinical Meeting, Sep 23, 2011

“Intranasal Abuse Potential of Immediate-Release Oxycodone (Accurox, IROA) Formulated to Deter Abuse (Poster Presentation).” College on Problems of Drug Dependence, Jun 2011

Publications

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Assay List

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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

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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

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