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Novel Approach for the Bioequivalence Assessment of Topical Cream Formulations: Model-Based Analysis of Tape Stripping Data Correctly Concludes BE and BIE.
Published in:
Pharmaceutical Research, 2020, v. 37, n. 2, p. 1, doi. 10.1007/s11095-019-2724-2
By:
- Ozdin, Deniz;
- Kanfer, Isadore;
- Ducharme, Murray P.
Publication type:
Article
Bioequivalence of oxycodone hydrochoride extended release tablets to marketed reference products OxyContin® in Canada and US.
Published in:
International Journal of Clinical Pharmacology & Therapeutics, 2013, v. 51, n. 11, p. 895, doi. 10.5414/CP201764
By:
- Gosai, Pritti;
- Ducharme, Murray P.;
- Godfrey, Anthony R.;
- Freeman, James C.;
- Monif, Tausif;
- Kumar, Kshirasagar Santosh;
- Kumar, Sudershan;
- Mudnaik, Rajesh;
- Katikaneni, Pruthvipathy
Publication type:
Article
Pharmacokinetics of a new diclofenac sodium formulation developed for subcutaneous and intramuscular administration.
Published in:
International Journal of Clinical Pharmacology & Therapeutics, 2012, v. 50, n. 6, p. 383, doi. 10.5414/CP201600
By:
- Zeitlinger, Markus;
- Rusca, Antonio;
- Oraha, Alhan Z.;
- Gugliotta, Barbara;
- Müller, Markus;
- Ducharme, Murray P.
Publication type:
Article
Pomelo juice, but not cranberry juice, affects the pharmacokinetics of cyclosporine in humans*.
Published in:
Clinical Pharmacology & Therapeutics, 2006, v. 79, n. 3, p. 255, doi. 10.1016/j.clpt.2005.11.010
By:
- Grenier, Julie;
- Fradette, Caroline;
- Morelli, Gaetano;
- Merritt, Gerald J.;
- Vranderick, Manon;
- Ducharme, Murray P.
Publication type:
Article
6′,7′-Dihydroxybergamottin in grapefruit juice and Seville orange juice: Effects on cyclosporine disposition, enterocyte CYP3A4, and P-glycoprotein*.
Published in:
Clinical Pharmacology & Therapeutics, 1999, v. 65, n. 3, p. 237, doi. 10.1016/S0009-9236(99)70102-5
By:
- Edwards, David J.;
- Fitzsimmons, Michael E.;
- Schuetz, Erin G.;
- Yasuda, Kazuto;
- Ducharme, Murray P.;
- Warbasse, Lawrence H.;
- Woster, Patrick M.;
- Schuetz, John D.;
- Watkins, Paul
Publication type:
Article
Itraconazole and hydroxyitraconazole serum concentrations are reduced more than tenfold by phenytoin*.
Published in:
Clinical Pharmacology & Therapeutics, 1995, v. 58, n. 6, p. 617, doi. 10.1016/0009-9236(95)90017-9
By:
- Ducharme, Murray P.;
- Slaughter, Richard L.;
- Warbasse, Lawrence H.;
- Chandrasekar, Pranatharthi H.;
- Van de Velde, Vera;
- Mannens, Geert;
- Edwards, David J.
Publication type:
Article
Disposition of intravenous and oral cyclosporine after administration with grapefruit juice*.
Published in:
Clinical Pharmacology & Therapeutics, 1995, v. 57, n. 5, p. 485, doi. 10.1016/0009-9236(95)90032-2
By:
- Ducharme, Murray P.;
- Warbasse, Lawrence H.;
- Edwards, David J.
Publication type:
Article
Rethinking bioequivalence and equivalence requirements of orally inhaled drug products.
Published in:
Asian Journal of Pharmaceutical Sciences, 2015, v. 10, n. 6, p. 461, doi. 10.1016/j.ajps.2015.08.006
By:
- Al-Numani, Dina;
- Colucci, Philippe;
- Ducharme, Murray P.
Publication type:
Article
Opportunities and Challenges Related to the Implementation of Model‐Based Bioequivalence Criteria.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 2, p. 350, doi. 10.1002/cpt.1270
By:
- Seng Yue, Corinne;
- Ozdin, Deniz;
- Selber‐Hnatiw, Susannah;
- Ducharme, Murray P.
Publication type:
Article
Model‐Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.
Published in:
2018
By:
- Fang, Lanyan;
- Kim, Myong‐Jin;
- Li, Zhichuan;
- Lionberger, Robert;
- Zhao, Liang;
- Wang, Yaning;
- DiLiberti, Charles E.;
- Au, Jessie;
- Hooker, Andrew;
- Ducharme, Murray P.
Publication type:
Proceeding
Revisiting FDA's 1995 Guidance on Bioequivalence Establishment of Topical Dermatologic Corticosteroids: New Research Based Recommendations.
Published in:
2018
By:
- Ozdin, Deniz;
- Sharma, Naveen;
- Lujan-Zilbermann, Jorge;
- Colucci, Philippe;
- Kanfer, Isadore;
- Ducharme, Murray P.
Publication type:
journal article
When Bioequivalence in Healthy Volunteers May not Translate to Bioequivalence in Patients: Differential Effects of Increased Gastric pH on the Pharmacokinetics of Levothyroxine Capsules and Tablets.
Published in:
2015
By:
- Seng Yue, Corinne;
- Benvenga, Salvatore;
- Scarsi, Claudia;
- Loprete, Luca;
- Ducharme, Murray P.
Publication type:
journal article
Novel population pharmacokinetic method compared to the standard noncompartmental approach to assess bioequivalence of iron gluconate formulations.
Published in:
2013
By:
- Seng Yue, Corinne;
- Gallicano, Keith;
- Labbé, Line;
- Ducharme, Murray P
Publication type:
journal article
Novel Population Pharmacokinetic Method Compared to the Standard Noncompartmental Approach to Assess Bioequivalence of Iron Gluconate Formulations.
Published in:
Journal of Pharmacy & Pharmaceutical Sciences, 2013, v. 16, n. 3, p. 424, doi. 10.18433/j3hs42
By:
- Seng Yue, Corinne;
- Gallicano, Keith;
- Labbé, Line;
- Ducharme, Murray P.
Publication type:
Article
Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 624, doi. 10.1002/psp4.12931
By:
- Gong, Yuqing;
- Zhang, Peijue;
- Yoon, Miyoung;
- Zhu, Hao;
- Kohojkar, Ameya;
- Hooker, Andrew C.;
- Ducharme, Murray P.;
- Gobburu, Jogarao;
- Cellière, Géraldine;
- Gajjar, Parmesh;
- Li, Bing V.;
- Velagapudi, Raja;
- Tsang, Yu Chung;
- Schwendeman, Anna;
- Polli, James;
- Fang, Lanyan;
- Lionberger, Robert;
- Zhao, Liang
Publication type:
Article
Single-Dose Pharmacokinetics of Sodium Ferric Gluconate Complex in Iron-Deficient Subjects.
Published in:
Pharmacotherapy, 2004, v. 24, n. 5, p. 574, doi. 10.1592/phco.24.6.574.34750
By:
- Seligman, Paul A.;
- Dahl, Naomi V.;
- Strobos, Jur;
- Kimko, Hui C.;
- Schleicher, Rhoda B.;
- Jones, Michael;
- Ducharme, Murray P.
Publication type:
Article
Enantioselective induction of cyclophosphamide metabolism by phenytoin.
Published in:
Chirality, 1999, v. 11, n. 7, p. 569, doi. 10.1002/(SICI)1520-636X(1999)11:7<569::AID-CHIR9>3.0.CO;2-R
By:
- Williams, Marion L.;
- Wainer, Irving W.;
- Embree, Leanne;
- Barnett, Michael;
- Granvil, Camille L.;
- Ducharme, Murray P.
Publication type:
Article
Pharmacokinetics of (R)- and (S)-cyclophosphamide and their dechloroethylated metabolites in cancer patients.
Published in:
Chirality, 1999, v. 11, n. 4, p. 301, doi. 10.1002/(SICI)1520-636X(1999)11:4<301::AID-CHIR7>3.0.CO;2-R
By:
- Williams, Marion L.;
- Wainer, Irving W.;
- Granvil, Camille P.;
- Gehrcke, Barbel;
- Bernstein, Mark L.;
- Ducharme, Murray P.
Publication type:
Article
Stop Costly Phase III Failures.
Published in:
Applied Clinical Trials, 2009, v. 18, n. 6, p. 4
By:
- Yue, Corinne Seng;
- Colucci, Philippe;
- Ducharme, Murray P.
Publication type:
Article
A randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1 study to determine the safety, pharmacokinetics and food and faecal microbiome effects of ibezapolstat administered orally to healthy subjects.
Published in:
2020
By:
- Garey, Kevin W;
- Begum, Khurshida;
- Lancaster, Chris;
- Gonzales-Luna, Anne;
- Bui, Dinh;
- Mercier, Julie;
- Yue, Corinne Seng;
- Ducharme, Murray P;
- Hu, Ming;
- Vince, Bradley;
- Silverman, Michael H;
- Alam, M Jahangir;
- Kankam, Martin;
- Seng Yue, Corinne
Publication type:
journal article

Found: 20

Novel Approach for the Bioequivalence Assessment of Topical Cream Formulations: Model-Based Analysis of Tape Stripping Data Correctly Concludes BE and BIE.

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

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

Pomelo juice, but not cranberry juice, affects the pharmacokinetics of cyclosporine in humans<sup>*</sup>.

6′,7′-Dihydroxybergamottin in grapefruit juice and Seville orange juice: Effects on cyclosporine disposition, enterocyte CYP3A4, and P-glycoprotein<sup>*</sup>.

Itraconazole and hydroxyitraconazole serum concentrations are reduced more than tenfold by phenytoin<sup>*</sup>.

Disposition of intravenous and oral cyclosporine after administration with grapefruit juice<sup>*</sup>.

Rethinking bioequivalence and equivalence requirements of orally inhaled drug products.

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

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

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

When Bioequivalence in Healthy Volunteers May not Translate to Bioequivalence in Patients: Differential Effects of Increased Gastric pH on the Pharmacokinetics of Levothyroxine Capsules and Tablets.

Novel population pharmacokinetic method compared to the standard noncompartmental approach to assess bioequivalence of iron gluconate formulations.

Novel Population Pharmacokinetic Method Compared to the Standard Noncompartmental Approach to Assess Bioequivalence of Iron Gluconate Formulations.

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop.

Single-Dose Pharmacokinetics of Sodium Ferric Gluconate Complex in Iron-Deficient Subjects.

Enantioselective induction of cyclophosphamide metabolism by phenytoin.

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

Stop Costly Phase III Failures.

A randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1 study to determine the safety, pharmacokinetics and food and faecal microbiome effects of ibezapolstat administered orally to healthy subjects.