Ducharme MP.
Model Master File (MMF) Applications for Long Acting Injectable Drug Products
Panelist at the upcoming 2024 Considerations and Potential Regulatory Applications for Model Master File Workshop, US FDA and CRCG, The University at Shady Grove. Rockville, MD, USA, May 2-3 2024
Rath S., Bakir D., Ducharme M., Kanfer I.
Can Model Based Approaches Accurately identify Bioequivalence of Topical Clotrimazole Products?
- Awarded Top Abstract Submission - Presented at the 2024 Annual ASCPT meeting, Colorado Springs, CO, USA, March 27-29 2024
Ducharme MP.
Model Based BE Approaches for Complex Generic Products
Presented at the 2024 Application of New Technology, Modelling, and Clinical Research Symposium, CEBIS, Ahmedabad, India, February 13, 2024
Bakir D., Ducharme MP.
Interoccasion Variability, Estimation Methods and Their Impact on Pharmacokinetic Estimates
Presented at the 2023 Annual ACCP meeting, Dallas, TX, USA, Nov 11-14 2023
Rath S., Bakir D., Ducharme MP., Kanfer I.
Model-Based Analysis for Determining Bioequivalence of Metronidazole Topical Cream
Presented at the 2023 Annual AAPS meeting, Orlando, FL, USA, October 22-25, 2023
Bakir D., Ducharme MP.
Investigating Inter-Occasion Variability and Estimation Methods
Presented at the 2023 Annual Population Approach Group Europe (PAGE) meeting, Coruna, Spain, June 28-30 2023
Ducharme MP.
PK/PD Modelling and Simulations: Important Concepts and Practical Case Reviews
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada. May 31, 2023
Ducharme MP.
The Role of PK/PD within the Drug Development Process: New Drug and Biologic Submissions
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, May 30, 2023
Ducharme MP.
The Role of PK/PD within the Drug Development Process: Generic Submissions
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, May 30, 2023
Ducharme MP.
Model-Based Approaches for Bioequivalence
Presentation given at the 2023 Bioavailability-Bioequivalence Memorial Meeting in Memory of Professor Laszlo Endrenyi, Athens, Greece, May 22-23 2023
Ducharme MP.
Model Integrated Evidence for BE Assessment of Long Acting Injectable Products: In Silico Continuation to Steady State
Presentation given at the FDA-CRCG Workshop on best practices for utilizing modeling approaches to support generic product development. October 27-28, 2022. USA (virtual)
Ducharme MP.
Model Integrated BE Approaches for Long Acting Injectables
Presentation given at the 2022 4th MENA Regulatory Conference. September 19-20, 2022. Amman, Jordan
Ducharme MP.
PK/PD Modelling and Simulations
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada. February 14-15, 2022
Ducharme MP.
PK/PD Modelling and Simulations
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada. February 7-8, 2022
Ducharme MP.
The Role of PK/PD within the Drug Development Process
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, December 20-21, 2021
Ducharme MP.
The Role of PK/PD within the Drug Development Process
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, December 3 and 6, 2021
Ducharme MP.
Model Integrated BE Approaches for Long Acting injectables
Presentation given at the virtual FDA and CRCG Workshop titled “Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products”. Baltimore and Bethesda, MD, USA. November 30, 2021
Ducharme MP, Seng Yue C, Scarsi C, Bettazzi E, Mautone G, Celi FS.
The Pharmacokinetics of a Novel Solution of Levothyroxine is not Influenced by Proton-Pump Inhibitor
Presented at the Virtual 2021 American Thyroid Association (ATA) Meeting, October 3rd 2021
Ducharme MP, Scarsi C, Bettazzi E, Mautone G, Celi FS
A Novel Solution of Levothyroxine Results in Clinically Similar Maximum and Extent of Exposure Whether Taken 30 or Just 15 Minutes Before a High-Fat High-Caloric Breakfast
Presented at the AACE Annual meeting 2021, May 26-29, 2021
Ducharme MP.
Application of Quantitative Clinical Pharmacology in Generic Drug Development: Generic Drug Industry Perspective
Given at the 2020 AAPS Annual Meeting, October 25-28 2020, New Orleans, LA, USA
Ducharme MP.
Bioequivalence Assessment of Topical Formulations
Given at the 2020 MENA Regulatory Conference, October 5-6 2020, Amman, Jordan.
De Jager R, Bruckner H, Bassali F, Hirschfeld A
Safe Moderate Dose Regimens Retain Full Survival Benefits for Aged Patients With and Without Resistant Gastrointestinal (GI) Cancers
Presented virtually at the ESMO WGI congress, July 1-3, 2020
Ducharme MP.
PK/PD Modelling and Simulations: Important Concepts and Practical Case Reviews
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, January 9 2020.
Ducharme MP.
The Role of PK/PD within the Drug Development Process: Generic Submissions
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, November 28, 2019.
Ducharme MP.
The Role of PK/PD within the Drug Development Process: New Drug and Biologic Submissions
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, November 28, 2019.
Ducharme MP.
The Role of PK/PD and of Modeling and Simulations in the Drug Development Process
Presentation given at Rockefeller University, NYC, USA, October 2, 2019.
Ducharme MP.
AUEC and Emax Modeling in BE Studies
Presentation given at the SAMnow International workshop, Rockville MD, USA, April 4-5 2019.
Ducharme MP.
PK/PD Modelling and Simulations: Important Concepts and Practical Case Reviews
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, January 7 2019.
Ducharme MP.
The Role of PK/PD within the Drug Development Process: New Drug and Biologic Submissions
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, November 27, 2018.
Ducharme MP.
The Role of PK/PD within the Drug Development Process: Generic Submissions
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, November 27, 2018.
Ducharme MP.
Approval of Inhalers Relying on Pharmacokinetic Data
Invited Guest, Health Canada’s Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT), Ottawa, Canada, November 02, 2018.
Colucci P.
PK Studies on Long-Acting Intramuscular Injectables: Challenges and Solutions
Presented at the First Annual Scientists Advancing Affordable Medicines Inc. Workshop, Baltimore, MD, USA, October 18-19, 2018.
Ducharme MP.
Scientific Arguments in Favor and Against the Requirements to Perform Steady State Studies for MR Products
Presented at the 3rd International Conference for GBHI, EUFEPS/EMA/FDA International BE Harmonisation Conference, Amsterdam, Netherlands, April 11-13 2018.
Ducharme MP.
PK/PD Modelling and Simulations: Important Concepts and Practical Case Reviews
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, January 15 2018.
Ducharme MP.
The role of PK/PD within the Drug Development Process: New Drug and Biologic Submissions
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, November 23, 2017
Ducharme MP.
The role of PK/PD within the Drug Development Process: Generic Submissions
Workshop given to the Office of Continuing Education, Health Products and Food branch, Health Canada, Ottawa, Canada, November 23, 2017.
Ducharme MP.
Strengths and Weaknesses of Population PK analyses for the assessment of Bioequivalence of complex and locally acting products
Given at the FDA Public Workshop, “Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review”, FDA White Oak Campus, Silver Springs, Maryland, Oct 2-3 2017.
Ducharme MP.
Regulatory requirements and current status of Bio equivalence studies in USA and EU (part 1 and part 2)
Seminars given to the Chinese FDA, Zhejiang University Quzhou Hospital International Center for BE studies and Aoreg Clinical Studies Co.Ltd., Quzhou, China, September 22, 2017.
Ducharme MP.
Understanding Generic and New Drug Submissions: Focus on Bioequivalence
Workshop given to Saudi Arabia Medical Doctors and Pharmacists, Pharmascience Event, Montreal, Qc, Canada, July 25 2017.
Ducharme MP.
Situations where BE assessment should be based on Metabolite data (only).
Presented at the Office of Generic Drugs, FDA, Silver Springs, MD, June 21 2017.
Ozdin D, Reddy S, Patnala S, Kanfer I, Ducharme MP.
Novel PK model using Tape Stripping data: Application in Bioequivalence assessment of two acyclovir topical cream formulations.
Presented at the 2017 CSPS Annual Meeting and Exposition, Montréal, Canada, May 10-12 2017 (Encore Presentation).
Ducharme MP.
Understanding Generic and New drug submissions: Focus on Bioequivalence
Workshop given to Vietnamese and Saudi Arabia Medical Doctors and Pharmacists, Pharmascience Event, Montréal, Canada, April 25 2017.
Ducharme MP.
PK/PD Modelling and Simulations: Important Concepts and Practical Case Reviews.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, January 24 2017.
Ducharme MP.
The role of PK/PD within the Drug Development Process: Generics, Biosimilars, New Drugs and Biologics.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, November 24 2016.
Ducharme MP.
Population Pharmacokinetic Modeling in Bioequivalence Assessment.
To be presented at the Generic Drug Market and Contract Manufacturing, Barcelona, Spain, Nov 7-9, 2016.
Ozdin D, Reddy S, Patnala S, Kanfer I, Ducharme MP.
Novel PK model using Tape Stripping data: Application in Bioequivalence assessment of two acyclovir topical cream formulations.
Presented (Abstract #03R0830) at the 2016 AAPS Annual Meeting and Exposition, Denver, CO, USA, Nov 13-17 2016.
Kanfer I, Ozdin D, Reddy S, Patnala S, Ducharme MP.
In vitro-In vivo correlation (IVIVC) of acyclovir cream formulations in human using tape stripping.
Presented (Abstract #03T0900) at the 2016 AAPS Annual Meeting and Exposition, Denver, CO, USA, Nov 13-17 2016.
Colucci P.
FDA 505(j) and 505(b)(2) requirements for follow on inhalation products.
Presented at the Inhalation Drug Delivery Association (IDDA) Fall Scientific Conference, Sun Yat-Sen University, GuangZhou, China, Nov 4-6, 2016.
Ducharme MP.
Situations where BE assessment should be based on metabolite data (only).
Presented at the 2016 EUFEPS/EMA/FDA International BE Harmonisation Conference, Hilton Rockville, MD, USA, Sept 14-15, 2016.
Ducharme MP.
Role of Modeling and Simulations in Biosimilar Development.
Dialogue and Debate session presented at the 2016 AAPS NBC, Boston, MA, May 18 2016.
Ducharme MP.
The Utility of PK/PD Modeling in Biosimilar Development.
Webinar given to TEVA Branded Pharmaceutical Products, February 23rd 2016.
Ducharme MP.
Two-Day PK Course.
Workshop given to Farmovs Parexel Ltd, Bloemfontein, South Africa, January 25-26 2016.
Ducharme MP.
PK/PD Modeling and Simulations: Important Concepts and Practical Case Reviews.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, January 11 2016.
Ducharme MP.
The role of PK/PD within the Drug Development Process: New Drugs and Biologics.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, November 26 2015.
Ducharme MP.
The role of PK/PD within the Drug Development Process: Generics.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, November 26 2015.
Ducharme MP.
Biosimilar Interchangeability - Standards, challenges, and regional differences regarding clinical practices, regulatory acceptability and oversight, industrial biosimilar development, substitution vs. interchangeability, and price containment.
2015 Annual Meeting of AAPS, October 27 2015, Orlando, FL, USA.
Ducharme MP.
Clinical Development of follow-on and generic inhaled products: Doing it the smart way.
Presentation given at Inhalation Asia 2015, September 9 2015, Shenyang, China.
Ducharme MP.
Clinical Development of Orally Inhaled Products.
Course given to Shenyang Pharmaceutical University, Shenyang, China, September 8 2015.
Ducharme MP.
Optimizing the Development of Biosimilars using PK/PD.
2015 National Biotechnology Conference of AAPS, June 8-11 2015, San Francisco, CA, USA.
Ducharme MP.
Understanding and practically applying global bioequivalence requirements: Established and emerging markets.
2015 BA/BE, Dissolution Testing and Biowaivers Workshop, Informa Life Sciences, May 19 2015, Prague, Czech Republic.
Ducharme MP.
Conducting Effective BE studies for Locally Acting Products.
2015 BA/BE, Dissolution Testing and Biowaivers Workshop, Informa Life Sciences, May 19 2015, Prague, Czech Republic.
Ducharme MP.
PK/PD Modeling and Simulations.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, March 16 2015.
Ducharme MP.
The role of PK/PD within the Drug Development Process: New Drugs and Biologics.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, January 8 2015.
Ducharme MP.
The role of PK/PD within the Drug Development Process: Generics.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, January 8 2015.
Ducharme MP.
Latest Development Trends in Clinical Trial Designs for Generic Studies.
Presented at the 2014 India Parexel Symposium "Navigating the Clinical Pathway for Oncology and Specialty Generic Drugs", Mumbai, India, December 12, 2014.
Ducharme MP.
Pathways for Complex and Differentiated Generics Drug Development in US, EU and Emerging markets.
Presented at the 2014 India Parexel Symposium "Navigating the Clinical Pathway for Oncology and Specialty Generic Drugs", Mumbai, India, December 12, 2014.
Ducharme MP.
Generic versus New Drug Submissions.
Presented in Dubai, Emirates, November 28, 2014.
Ducharme MP.
Dose-Scale Pharmacodynamic Bioequivalence studies – Practical considerations.
Presented at the 2014 AAPS Annual Meeting, San Diego, USA, Nov 6 2014.
Ducharme MP.
Pharmacokinetics of Levothyroxine in altered gastric pH conditions caused by proton pump inhibitors.
Presented at the 2014 ETA Annual Meeting, Santiago de Compostela, Spain, Sept 8 2014.
Ducharme MP.
AAPS NBC Bio-Talk: First in Man and Clinical Pharmacology Studies for Drugs and Biologics.
Given at the 2014 NBC AAPS Meeting, San Diego, CA, USA, May 20 2014.
Ducharme MP.
The role of PK/PD within the Drug Development Process: Generic and Supergeneric submission.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, February 25 2014.
Ducharme MP.
The role of PK/PD within the Drug Development Process: New Drug/Biologic submissions.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, February 25 2014.
Ducharme MP.
PUpdate on the Health Canada BA/BE requirements.
Presented at the 3rd International Bioequivalence, Biowaivers and Dissolution Conference, AAPS/Rhodes University, Grahamstown, South Africa, December 3 2013.
Ducharme MP.
Biosimilars: Regulatory requirements for market approval.
Presented at the 3rd International Bioequivalence, Biowaivers and Dissolution Conference, AAPS/Rhodes University, Grahamstown, South Africa, December 3 2013.
Ducharme MP.
The role of PK/PD within the Drug Development Process: Generic and Supergeneric submission.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, November 25 2013.
Ducharme MP.
The role of PK/PD within the Drug Development Process: New Drug/Biologic submissions.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, November 25 2013.
Ducharme MP.
Global Regulatory Requirements for Inhalers.
Presented at the 2013 AAPS Annual Meeting, San Antonio, Texas, USA, November 12 2013.
Ducharme MP.
New FDA requirements for establishing Bioequivalence of drugs with narrow therapeutic index.
Presented at the 2013 AAPS Annual Meeting, San Antonio, Texas, USA, November 12 2013.
Ducharme MP.
Bioequivalence - Clinical Endpoint Studies.
Presented at the 2013 GPhA Fall Technical Meeting, Bethesda, MD, USA, October 29 2013.
Ducharme MP.
Clinical comparability of Biosimilars: Metrics and Methods.
Presented at the 2013 National AAPS Biotechnology Conference, San Diego, CA, May 22 2013.
Ducharme MP.
Biosimilars: The Quest for Interchangeability.
Presented at the 2013 National AAPS Biotechnology Conference, San Diego, Ca. May 22 2013.
Seng Yue C, Potvin D, Ducharme MP.
Determination of a minimal effective dosing regimen with population pharmacokinetic and pharmacodynamic modeling.
Presented at the 2013 National AAPS Biotechnology Conference, San Diego, CA, May 21, 2013.
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. Presented at the 54 thASH Annual Meeting, Atlanta, USA, Dec 8-11 2012.
Ducharme MP.
The role of PK/PD within the Drug Development Process: Generic and Supergeneric submissions.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, December 3rd 2012.
Ducharme MP.
The role of PK/PD within the Drug Development Process: New Drug/Biologic submissions.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, December 3rd 2012.
Kanfer I, Muller A, Ducharme MP.
Interactions between Sutherlandia frutescens, and African traditional medicine and the antiretroviral protease inhibitor, atazanavir, in human subjects.
Presented at the 2012 Annual AAPS meeting, Chicago, IL, USA, Oct 14-18 2012.
Benvega S, Ducharme MP.
Effect of proton pump inhibitors (PPIs) on the relative bioavailability of Levothyroxine (LT4) in soft gel capsules and in tablets.
Presented at the 2012 ATA meeting, Quebec City, Sept. 2012.
Knapper S, Smith M, Chevassut T, Colucci P, Johansen M, Hagen S, Hals PA, Jacobsen TF, Dirven H, Ducharme MP.
The pharmacokinetics of Elacytarabine in AML.
Presented at the 2012 European Hematology Association (EHA) meeting, Amsterdam, June 2012.
Benvega S, Ducharme MP.
Effect of gastric pH on the bioavailability of levothyroxine (LT4) in soft gel capsules and in tablets: Results from a pharmacokinetic study in healthy volunteers.
Presented at the 94th Annual Meeting & Expo ENDO 2012, Houston, TX, USA, June 2012.
Kanfer I, Ducharme MP.
The New Canadian BE guidelines in the midst of current challenges from a regulatory and industry point of view.
Chair and Panel Speakers, Canadian Society of Pharmaceutical Scientists (CSPS), Toronto, Ontario, June 13 2012.
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. Presented at the 2012 ASCO Annual Meeting, June 4 2012, Chicago, IL, USA.
Ducharme MP.
Pharmacokinetics of an oral solution of Levothyroxine in healthy adults vs. solid dosage forms.
Presented at the International Congress of Endocrinology/European Congress of Endocrinology (ICE-ECE), Firenze, Italy, May 6 2012.
Ducharme MP.
Four-day course in PK/PD analysis using NONMEM(R).
AstraZeneca R&D, Montreal, Canada, Feb 13-16, 2012.
Ducharme MP.
The role of PK/PD within the Drug Development Process: Generic and Supergeneric submissions.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, February 2nd 2012.
Ducharme MP.
The role of PK/PD within the Drug Development Process: New Drug/Biologic submissions.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, February 2nd 2012.
Ducharme MP.
Bioequivalence assessment of Inhalation dosage forms.
Presented at the AAPS/Rhodes University BE Workshop , Rhodes University, Grahamstown, South Africa, December 7-9 2011.
Ducharme MP.
Is there a Best Recipe for Food Effect Studies?
Presented at the AAPS/Rhodes University BE Workshop , Rhodes University, Grahamstown, South Africa, December 7-9 2011.
Ducharme MP.
Requirements for BE testing of Modified / Controlled release dosage forms – International update Development Process: Generic and Supergeneric submissions.
Presented at the AAPS/Rhodes University BE Workshop , Rhodes University, Grahamstown, South Africa, December 7-9 2011.
Ducharme MP.
The role of PK/PD within the Drug Development Process: Generic and Supergeneric submissions.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, November 3rd 2011.
Ducharme MP.
The role of PK/PD within the Drug Development Process: New Drug/Biologic submissions.
Workshop given to the Office of Continuing Education, Health Products and Food Branch, Health Canada, Ottawa, Canada, November 3rd 2011.
Ducharme MP.
Demonstrating Bioequivalence using PD measures or clinical endpoints.
Presented at the 2011 AAPS Annual Meeting. Washington, DC, USA, October 27 2011.
Ducharme MP.
Panel speaker for the "Mini Syposium on Bioequivalence considerations for Alternative dosage form modified-release products.
2011 AAPS Annual Meeting. Washington, DC, USA, October 26 2011.
Ducharme MP.
Intestinal malabsorption of Levothyroxine and the PK of a new formulation in softgel capsules.
Presented at the 15th International ETC Thyroid Congress, Krakow, Poland, September 12, 2011.