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Items: 1 to 50 of 61

1.
2.

Revisiting FDA's 1995 Guidance on Bioequivalence Establishment of Topical Dermatologic Corticosteroids: New Research Based Recommendations.

Ozdin D, Sharma N, Lujan-Zilbermann J, Colucci P, Kanfer I, Ducharme MP.

J Pharm Pharm Sci. 2018;21(1):413-428. doi: 10.18433/jpps30021.

3.

Opportunities and Challenges Related to the Implementation of Model-Based Bioequivalence Criteria.

Seng Yue C, Ozdin D, Selber-Hnatiw S, Ducharme MP.

Clin Pharmacol Ther. 2019 Feb;105(2):350-362. doi: 10.1002/cpt.1270. Epub 2019 Jan 8.

PMID:
30375647
5.

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.

Fang L, Kim MJ, Li Z, Wang Y, DiLiberti CE, Au J, Hooker A, Ducharme MP, Lionberger R, Zhao L.

Clin Pharmacol Ther. 2018 Jul;104(1):27-30. doi: 10.1002/cpt.1065. Epub 2018 Mar 30. Erratum in: Clin Pharmacol Ther. 2018 Nov;104(5):1030.

PMID:
29603191
6.

Effect of Food on the Pharmacokinetics of Single- and Multiple-Dose Hydrocodone Extended Release in Healthy Subjects.

Bond M, Rabinovich-Guilatt L, Selim S, Darwish M, Tracewell W, Robertson P Jr, Yang R, Malamut R, Colucci P, Ducharme MP, Spiegelstein O.

Clin Drug Investig. 2017 Dec;37(12):1153-1163. doi: 10.1007/s40261-017-0575-3.

PMID:
28948482
7.

Leader Influence, the Professional Practice Environment, and Nurse Engagement in Essential Nursing Practice.

Ducharme MP, Bernhardt JM, Padula CA, Adams JM.

J Nurs Adm. 2017 Jul/Aug;47(7-8):367-375. doi: 10.1097/NNA.0000000000000497.

PMID:
28678050
8.

Levothyroxine soft capsules demonstrate bioequivalent pharmacokinetic exposure with the European reference tablets in healthy volunteers under fasting conditions.

Al-Numani D, Scarsi C, Ducharme MP.

Int J Clin Pharmacol Ther. 2016 Feb;54(2):135-43. doi: 10.5414/CP202485.

PMID:
26754305
10.
11.

Impact of Tesamorelin, a Growth Hormone-Releasing Factor (GRF) Analogue, on the Pharmacokinetics of Simvastatin and Ritonavir in Healthy Volunteers.

Teng S, Potvin D, Mamputu JC, Vincent G, Zoltowska M, Morin J, Hatimi S, Michaud SE, High K, Ducharme MP.

Clin Pharmacol Drug Dev. 2013 Jul;2(3):237-45. doi: 10.1002/cpdd.27. Epub 2013 May 15.

PMID:
27121785
12.

Bioequivalence of oxycodone hydrochoride extended release tablets to marketed reference products OxyContin® in Canada and US.

Gosai P, Ducharme MP, Godfrey AR, Freeman JC, Monif T, Kumar KS, Kumar S, Mudnaik R, Katikaneni P.

Int J Clin Pharmacol Ther. 2013 Nov;51(11):895-907. doi: 10.5414/CP201764.

PMID:
23673291
13.

Pharmacokinetics and potential advantages of a new oral solution of levothyroxine vs. other available dosage forms.

Yue CS, Scarsi C, Ducharme MP.

Arzneimittelforschung. 2012 Dec;62(12):631-6. doi: 10.1055/s-0032-1329951. Epub 2012 Nov 15.

PMID:
23154888
14.

Pharmacokinetics of a new diclofenac sodium formulation developed for subcutaneous and intramuscular administration.

Zeitlinger M, Rusca A, Oraha AZ, Gugliotta B, Müller M, Ducharme MP.

Int J Clin Pharmacol Ther. 2012 Jun;50(6):383-90.

PMID:
22677302
15.

Performance of different population pharmacokinetic algorithms.

Colucci P, Grenier J, Yue CS, Turgeon J, Ducharme MP.

Ther Drug Monit. 2011 Oct;33(5):583-91. doi: 10.1097/FTD.0b013e318232bc61.

PMID:
21912327
17.

Pharmacokinetic equivalence of a levothyroxine sodium soft capsule manufactured using the new food and drug administration potency guidelines in healthy volunteers under fasting conditions.

Colucci P, D'Angelo P, Mautone G, Scarsi C, Ducharme MP.

Ther Drug Monit. 2011 Jun;33(3):355-61. doi: 10.1097/FTD.0b013e318217b69f.

PMID:
21516059
18.

Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report.

O'Connor D, Adams WP, Chen ML, Daley-Yates P, Davis J, Derendorf H, Ducharme MP, Fuglsang A, Herrle M, Hochhaus G, Holmes SM, Lee SL, Li BV, Lyapustina S, Newman S, Oliver M, Patterson B, Peart J, Poochikian G, Roy P, Shah T, Singh GJ, Sharp SS.

J Aerosol Med Pulm Drug Deliv. 2011 Jun;24(3):119-35. doi: 10.1089/jamp.2011.0878. Epub 2011 Mar 31.

PMID:
21453049
19.

Effect of a single dose of ritonavir on the pharmacokinetic behavior of elvucitabine, a nucleoside reverse transcriptase inhibitor, administered in healthy volunteers.

Colucci P, Pottage JC, Robison H, Turgeon J, Ducharme MP.

Antimicrob Agents Chemother. 2009 Feb;53(2):646-50. doi: 10.1128/AAC.00905-08. Epub 2008 Nov 17.

20.

Multiple-dose pharmacokinetic behavior of elvucitabine, a nucleoside reverse transcriptase inhibitor, administered over 21 days with lopinavir-ritonavir in human immunodeficiency virus type 1-infected subjects.

Colucci P, Pottage JC, Robison H, Turgeon J, Schürmann D, Hoepelman IM, Ducharme MP.

Antimicrob Agents Chemother. 2009 Feb;53(2):662-9. doi: 10.1128/AAC.00907-08. Epub 2008 Nov 17.

21.

Pharmacodynamic equivalence of two orlistat capsule formulations in healthy volunteers under fed conditions.

Di Marco M, Marier JF, Ducharme MP, Morin I, Engel C, Gulbranson S, Thudi NR, Murpani D, Rampal A, Monif T, Koundinya TS, Deo K, Monif T.

Int J Clin Pharmacol Ther. 2008 Jun;46(6):319-26.

PMID:
18541129
23.

Phase I dose escalation pharmacokinetic study in healthy volunteers of resveratrol, a potential cancer chemopreventive agent.

Boocock DJ, Faust GE, Patel KR, Schinas AM, Brown VA, Ducharme MP, Booth TD, Crowell JA, Perloff M, Gescher AJ, Steward WP, Brenner DE.

Cancer Epidemiol Biomarkers Prev. 2007 Jun;16(6):1246-52.

24.

Two open-label, randomized, crossover studies assessing the bioequivalence of ofloxacin administered as immediate-and extended-release formulations in healthy subjects.

Marier JF, Ducharme MP, DiMarco M, Di Spirito M, Morelli G, Tippabhotla SK, Badri N, Rampal A, Monif T.

Clin Ther. 2006 Dec;28(12):2070-80.

PMID:
17296463
25.

Pomelo juice, but not cranberry juice, affects the pharmacokinetics of cyclosporine in humans.

Grenier J, Fradette C, Morelli G, Merritt GJ, Vranderick M, Ducharme MP.

Clin Pharmacol Ther. 2006 Mar;79(3):255-62. Epub 2006 Feb 7.

PMID:
16513449
26.

The utility of the population approach applied to bioequivalence in patients: comparison of 2 formulations of cyclosporine.

Fradette C, Lavigne J, Waters D, Ducharme MP.

Ther Drug Monit. 2005 Oct;27(5):592-600.

PMID:
16175132
27.

Phase I and pharmacokinetic study of DE-310 in patients with advanced solid tumors.

Soepenberg O, de Jonge MJ, Sparreboom A, de Bruin P, Eskens FA, de Heus G, Wanders J, Cheverton P, Ducharme MP, Verweij J.

Clin Cancer Res. 2005 Jan 15;11(2 Pt 1):703-11.

28.

A population pharmacokinetic-metabolism model for individualizing ciprofloxacin therapy in ophthalmology.

Di Marco MP, Chen J, Wainer IW, Ducharme MP.

Ther Drug Monit. 2004 Aug;26(4):401-7.

PMID:
15257070
29.

Single-dose pharmacokinetics of sodium ferric gluconate complex in iron-deficient subjects.

Seligman PA, Dahl NV, Strobos J, Kimko HC, Schleicher RB, Jones M, Ducharme MP.

Pharmacotherapy. 2004 May;24(5):574-83.

PMID:
15162891
30.

Pharmacokinetics of omeprazole in healthy adults and in children with gastroesophageal reflux disease.

Marier JF, Dubuc MC, Drouin E, Alvarez F, Ducharme MP, Brazier JL.

Ther Drug Monit. 2004 Feb;26(1):3-8.

PMID:
14749542
31.
33.
34.

Metabolism and disposition of resveratrol in rats: extent of absorption, glucuronidation, and enterohepatic recirculation evidenced by a linked-rat model.

Marier JF, Vachon P, Gritsas A, Zhang J, Moreau JP, Ducharme MP.

J Pharmacol Exp Ther. 2002 Jul;302(1):369-73.

PMID:
12065739
35.

A pharmacokinetic study of amoxycillin in febrile beagle dogs following repeated administrations of endotoxin.

Marier JF, Beaudry F, Ducharme MP, Fortin D, Moreau JP, Massé R, Vachon P.

J Vet Pharmacol Ther. 2001 Dec;24(6):379-83.

PMID:
11903867
36.

Phase I study of topoisomerase I inhibitor exatecan mesylate (DX-8951f) given as weekly 24-hour infusions three of every four weeks.

Sharma S, Kemeny N, Schwartz GK, Kelsen D, O'Reilly E, Ilson D, Coyle J, De Jager RL, Ducharme MP, Kleban S, Hollywood E, Saltz LB.

Clin Cancer Res. 2001 Dec;7(12):3963-70.

37.

Phase I and pharmacokinetic study of exatecan mesylate (DX-8951f): a novel camptothecin analog.

Royce ME, Hoff PM, Dumas P, Lassere Y, Lee JJ, Coyle J, Ducharme MP, De Jager R, Pazdur R.

J Clin Oncol. 2001 Mar 1;19(5):1493-500.

PMID:
11230496
38.

A population analysis of nebulized (R)-albuterol in dogs using a novel mixed gut-lung absorption PK-PD model.

Auclair B, Wainer IW, Fried K, Koch P, Jerussi TP, Ducharme MP.

Pharm Res. 2000 Oct;17(10):1228-35.

PMID:
11145228
39.
40.
41.

Enantioselective induction of cyclophosphamide metabolism by phenytoin.

Williams ML, Wainer IW, Embree L, Barnett M, Granvil CL, Ducharme MP.

Chirality. 1999;11(7):569-74.

PMID:
10423284
42.

Piperacillin and tazobactam exhibit linear pharmacokinetics after multiple standard clinical doses.

Auclair B, Ducharme MP.

Antimicrob Agents Chemother. 1999 Jun;43(6):1465-8.

43.

Pharmacokinetics of (R)- and (S)-cyclophosphamide and their dechloroethylated metabolites in cancer patients.

Williams ML, Wainer IW, Granvil CP, Gehrcke B, Bernstein ML, Ducharme MP.

Chirality. 1999;11(4):301-8.

PMID:
10224657
44.

6',7'-Dihydroxybergamottin in grapefruit juice and Seville orange juice: effects on cyclosporine disposition, enterocyte CYP3A4, and P-glycoprotein.

Edwards DJ, Fitzsimmons ME, Schuetz EG, Yasuda K, Ducharme MP, Warbasse LH, Woster PM, Schuetz JD, Watkins P.

Clin Pharmacol Ther. 1999 Mar;65(3):237-44.

45.

On-line deconjugation of chloramphenicol-beta-D-glucuronide on an immobilized beta-glucuronidase column. Application to the direct analysis of urine samples.

Pasternyk M, Ducharme MP, Descorps V, Felix G, Wainer IW.

J Chromatogr A. 1998 Dec 18;828(1-2):135-40.

PMID:
9916301
46.
47.

On-line deconjugation of glucuronides using an immobilized enzyme reactor based upon beta-glucuronidase.

Di Marco MP, Felix G, Descorps V, Ducharme MP, Wainer IW.

J Chromatogr B Biomed Sci Appl. 1998 Sep 18;715(2):379-86.

PMID:
9792524
48.

Novel pharmacokinetic modelling of transdermal nitroglycerin.

Auclair B, Sirois G, Ngoc AH, Ducharme MP.

Pharm Res. 1998 Apr;15(4):614-9.

PMID:
9587959
49.
50.

Phenytoin-induced alteration in the N-dechloroethylation of ifosfamide stereoisomers.

Ducharme MP, Bernstein ML, Granvil CP, Gehrcke B, Wainer IW.

Cancer Chemother Pharmacol. 1997;40(6):531-3.

PMID:
9332469

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