Ducharme MP
Canada's Bioequivalence Requirements
In: Kanfer I, ed. Bioequivalence Requirements in various Global Jursidictions. 2nd Edition. Springer, 2024 (In Press)
Seng Yue C, Scarsi C, Bettazzi E, Mautone G, Celi FS,Ducharme M P
Proton-pump inhibitors do not affect the bioavailability of a novel liquid formulation of levothyroxine
Endocr Pract. 2024 Mar 28:S1530-891x(24)00471-3 (Online Ahead of Print)
Walenga RL, Babiskin AH, Bhoopathy S, Clarke JF, De Backer J,Ducharme MP, Kelly M, LE Merdy M, Yoon M, Roy P
Use of the same model or model strategy across multiple submissions: Focus on complex drug products
AAPS J 2024 Jan 4;26(1):1-12
Gong Y, Zhang P, Yoon M, Zhu H, Kohojkar A, Hooker AC, Ducharme MP, Gobburu J, Celliere G, Gajjar P, Li BV, Velagapudi R, Tsang YC, Scgwendeman A, Polli J, Fang L, Lionberger R, Zhao L
Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: summary of workshop
CPT Pharmacometrics Syst Pharmacol 2023 May;12(5):624-630
Ducharme MP and Shargel L (Editors)
Applied Biopharmaceutics and Pharmacokinetics, 8th edition. McGraw Hill, 2022
Ducharme M, Scarsi C, Bettazzi E, Mautone G, Lewis Y, Celi FS
A nodel levothyroxine solution results in similar bioavailability whether taken 30 or just 15 minutes before a high-fat high-calorie meal
Thyroid 2022;32(8):897-904
Ducharme M, Seng Yue C, Scarsi C, Bettazzi E, Mautone G, Celi F
The pharmacokinetics of a novel solution of levothyroxine is not influenced by proton pump inhibitors
Thyroid 2021;31(Suppl 1):A140-141
Kereiakes DJ, Henry TD, DeMaria AN, Bentur O, Carlson M, Seng Yue C, Martin LH, Midkiff J, Mueller M, Meek T, Garza D, Gibson CM, Coller BS
First Human Use of RUC-4, a Non-Activating Second Generation Small Molecule Platelet Glycoprotein IIb/IIIa (Integrin αIIbβ3) Inhibitor, Designed for Subcutaneous Point-of-Care Treatment of ST Segment Elevation Myocardial Infarction (STEMI).
J Am Heart Assoc. 2020;9:e016552
Lickliter J, Kanceva R, Vincent E, Schueler A, Harrison-Moench E, Seng Yue C, Stahl M, Ullmann M, Ghori V, Griffin P
Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta® in Healthy Subjects: a Randomized, Double-blind Trial
Clinical Therapeutics, In Press.
Garey KW, Begum K, Lancaster C, Gonzales-Luna AJ, Bui D, Mercier J, Seng Yue C, Ducharme MP, Hu M, Vince B, Silverman MH, Alam MJ, Kankam M.
Randomized, Double blind, Placebo controlled, Single and Multiple Ascending Dose Phase 1 Study to Determine the Safety, Pharmacokinetics, Food, and Fecal Microbiome Effects of Ibezapolstat Administered Orally to Healthy Subjects.
J Antimicrob Chemother, In Press. Accepted July 17, 2020
Ozdin D, Kanfer I, Ducharme MP.
Novel approach for the bioequivalence assessment of topical cream formulations: Model-based analysis of tape stripping data correctly concludes BE and BIE.
Pharm Res 2020 Jan 2;37(2):20.
Seng Yue C, Ozdin D, Selber-Hnatiw S, Ducharme M
Opportunities and challenges related to the implementation of model-based bioequivalence criteria.
Clin Pharm Ther 2019;105(2):350-362.
Ozdin D, Sharma N, Lujan-Zilbermann J, Colucci P, Kanfer I, Ducharme MP
Revisiting FDA’s 1995 guidance on bioequivalence establishment of topical dermatologic corticosteroids: New research based recommendations.
J Pharm Pharm Sci 2018;21(1):413-428.
Chen ML, Blume H, Veuerle G, Mehta M, Potthast H, Brandt A, Schug BS, Ducharme M, Endrenyi L, Gallicano K, Schuirmann D, Welink J.
Summary report of second EUFEPS/AAPS conference on global harmonization in Bioequivalence.
Eur J Pharm Sci 2019; 127:24-28.
Muller AC, Ducharme MP, Kanfer I.
Identification of mechanism and pathway of the interaction between the African traditional medicine, Sutherlandia Frutescens, and the antiretroviral protease inhibitor, Altazanavir, in human subjects using population pharmacokinetic (PK) analysis.
J Pharm Pharm Sci 2018;21(1s):215s-221s.
Fang L, Kim MJ, Li Z, Wang Y, DiLiberti CE, Au J, Hooker A, Ducharme MP, Lionberger R, Zhao L.
Model-Informed Drug Development and Review for Generic Products : Summary of FDA Public Workshop.
Clin Pharmacol Ther 2018;104(1):27-30.
Bond M, Rabinovitch-Guilatt L, Selim S, Darwish M, Tracewell W, Robertson P, Yang R, Malamut R, Colucci P, Ducharme MP, Spiegelstein O.
Effect of food on the pharmacokinetics of single and multiple-dose hydrocodone extended release in healthy subjects.
Clin Drug Invest 2017;37(12):1153-1163.
Al-Numani D, Scarsi C, Ducharme MP.
Levothyroxine soft capsules demonstrate bioequivalent pharmacokinetic exposure with the European reference tablets in healthy volunteers under fasting conditions.
Int J Clin Pharmacol Ther 2016;54(2):135-143.
Seng Yue C, Benvega S, Scarsi C, Loprete L, Ducharme M.
When bioequivalence in h ealthy volunteers may not translate to bioequivalence in patients: Differential effects of increased gastric pH on the pharmacokinetics of levothyroxine capsules and tablets.
J Pharm Pharm. Sci 2015;18(5):844-855.
Al Numani D, Colucci P, Ducharme MP.
Rethinking bioequivalence and equivalence requirements of orally inhaled drug products.
Asian J Pharm. Sci2015;10:461-471.
Ducharme MP.
Chapter 7: Drug Elimination, Clearance and Renal clearance. In : Shargel L, Yu A eds. Applied Biopharmaceutics and Pharmacokinetics, 7th edition.
McGraw Hill, 2015:149-175.
Seng Yue C, Ducharme MP.
Chapter 25 : Empirical models, mechanistic models and noncompartmental analysis. In : Shargel L, Yu A eds. Applied Biopharmaceutics and Pharmacokinetics, 7th edition.
McGraw Hill, 2015:817-849.
Colucci P, Ducharme MP.
Appendix A: Applications of software packages in Pharmacokinetics. In : Shargel L, Yu A eds. Applied Biopharmaceutics and Pharmacokinetics, 7th edition.
McGraw Hill, 2015:851-874.
Teng S, Potvin D, Mamputu JC, Vincent G, Zoltowska M, Morin J, Hatimi S, Michaud SE, High K, Ducharme MP.
Impact of Tesamorelin, a growth hormone-releasing factor (GRF) analogue, on the pharmacokinetics of simvastatin and ritonavir in healthy volunteers.
Clin Pharm Drug Dev 2013;2(3):237-245.
Seng Yue C, Gallicano K, Labbe, Ducharme MP.
Novel population pharmacokinetic method compared to the standard noncompartmental approach to assess bioequivalence of iron gluconate formulations.
J Pharm Pharm Sci2013;16(3):424-440.
Gosai P, Ducharme MP, Godfrey AR, Freeman JC, Monif T, Kumar KS, Kumar S, Mudnaik R, Katikaneni P.
Bioequivalence of oxycodone hydrochloride extended release tablets to marketed reference products Oxycontin(R) in Canada and US. Int
J Clin Pharmacol Ther2013 May 14 (Epub ahead of print).
Colucci P, Seng Yue C, Ducharme M, Benvega S.
A review of the Pharmacokinetics of Levothyroxine for the Treatment of Hypothyroidism.
European Endocrinology 2013;9(1):40-47.
Seng Yue C, Gandhi V, O’Brien S, Ravandi F, Jacobsen TF, Dirven H, Hagen S, Hals PA, Ducharme MP.
Novel Population Pharmacokinetic modeling of Arabinosyl Cytosine Triphosphate: Insights on potential preferential formation of Ara-CTP directly from Elacytarabine as well as from Ara-C.
Yue CS, Scarsi C, Ducharme MP.
Pharmacokinetics and potential advantages of a new oral solution Levothyroxine vs. other available dosage forms.
Arzneimittelforschung 2012 Dec. 62(12):631-636.
Zeitlinger M, Rusca A, Oraha AZ, Gugliotta B, Muller M, Ducharme MP.
Pharmacokinetics of a new diclofenac sodium formulation developed for subcutaneous and intramuscular administration.
Int J Clin Pharmacol Ther 2012;50(6):383-390.
Ducharme MP, Hagen S, Halls PA, Jacobsen TF, Giles FJ, O'Brien SM, Dirven H, Colucci P, Seng Yue C.
Initial characterization of the toxicity and efficacy of elacytarabine (CP-4055), a novel antileukemic agent, using a multi-dimensional exposure-response relationship model.
J Clin Oncol 2012;30(Suppl):6619.
Muller AC, Patnala S, Kis O, Bendayan R, Kanfer I.
Interactions between phytochemical components of Sutherlandia Frutescens and the Antiretroviral Atazanavir in vitro: Implications for absorption and metabolism.
J Pharm Pharm Sci2012;15(2))221-233.
Waldmann S, Almukainzi M, Bou-Chacra NA, Amidon GL, Lee BJ, Feng J, Kanfer I, Zuo JZ, Wei H, Bolger MB, Lobenberg R.
Provisional biopharmaceutical classification of some common herbs used in western medicine.
Mol Pharm 2012; Mar 14.
Chen ML, Shah VP, Crommelin DJ, Shargel L, Bashaw D, Bhatti M, Blume H, Dressman J, Ducharme M, Fackler P, Hyslop T, Lutter L, Morais J, Ormsby E, Thomas S, Tsang YC, Velagapudi R, Yu LX.
Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: Workshop Summary Report.
AAPS J 2011;13(4):556-564.
Muller AC, Kanfer I.
Potential pharmacokinetic interactions between antiretrovirals and medicinal plants used as complementary and african traditional medicines.
Biopharm Drug Dispos 2011; 32(8):458-470.
Chen ML, Shah VP, Crommelin DJ, Shargel L, Bashaw D, Bhatti M, Blume H, Dressman J, Ducharme M, Fackler P, Hyslop T, Lutter L, Morais J, Ormsby E, Thomas S, Tsang YC, Velagapudi R, Yu LX.
Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: Workshop summary report.
Eur J Pharm Sci 2011;44:506-513.
Christie M, Lavergne V, Sikaneta T, Seng Yue C, Taskapan H, Tam PW, Ayoub P, Ting R, Leblanc D, Ghannoum M.
Hyperaluminemia during long-term dialysis: still relevant today.
Am J Kidney Dis. 2011 Nov;58(5):861-3.
Colucci P, Grenier J,Yue CS, Turgeon J, Ducharme MP.
Performance of different population pharmacokinetic algorithms.
Ther Drug Monit 2011 Oct;33(5):583-591.
Seng Yue C, Christie M, Lavergne V, Sikaneta T, Taskapan H, Mardini K, Tam P, Ting R, Ghannoum M.
Aluminum toxicokinetics in peritoneal dialysis patients.
Clin Toxicol (Phila). 2011 Aug; 49(7):659-63.
Colucci P, Turgeon J, Ducharme MP.
How critical is the duration of the sampling scheme for the determination of half-life, characterization of exposure and assessment of bioequivalence?
J Pharm Pharm Sci2011;14(2):217-226.