Why DMPK matters?
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Drug metabolism and pharmacokinetics (DMPK) is the study of how the body processes and affects drugs, covering their absorption, distribution, metabolism, and excretion (ADME), along with evaluating potential drug-drug interactions (DDI).
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Early assessment of ADME and DDI properties of lead compounds has greatly lowered drug failure rates due to poor DMPK properties.[1]
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Inadequate PK properties in humans still account for 16% Phase I failures.[2]
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Notable examples of drugs withdrawn from the market due to undesirable DMPK properties include mibefradil, terfenadine, cerivastatin and troglitazone.
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The key DMPK questions you must answer at the drug discovery and development stages are:
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Will the human projected dosing regimen provide sufficient exposure for efficacy and align with the target product profile?
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Will selected safety species provide adequate drug exposure and human metabolite coverage?
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Is the drug candidate clinically safe and free from DDI potential?
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Navigating DMPK challenges: Insights & solutions from your expert consultant
Here are a few examples of DMPK solutions implemented to address challenges in the 15+ projects I've been involved in over the past 20+ years in the industry:
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Optimized compound properties to overcome ADME issues and achieve the desired oral exposure with drug candidates.
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Collaborated on establishing PK/PD and PK-Efficacy relationships in preclinical pharmacology models.
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Performed human PK and dose projections to help drug candidate selection, confirm alignment with target product profile and support clinical development activities.
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Guided species selection for toxicity studies based on exposure and coverage of human metabolites.
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Mitigated DDI issues (inhibition, induction) in lead series at the drug discovery stage.
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Predicted DDI potential to guide compound selection and help prioritize clinical DDI studies.
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Played a key role in identifying and minimizing the formation of reactive intermediates during lead optimization.
My services as a DMPK consultant
My consulting services at drug discovery & early development stages include:
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Identification of DMPK liabilities in lead compounds and series.
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Strategies to optimize PK, ADME, DDI and drug-like properties.
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In vitro and in vivo DMPK study design and CRO collaboration.
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Preclinical DMPK result analysis and interpretation.
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Human PK parameter projections from nonclinical data.
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Predictions of human efficacious doses based on nonclinical PK & PD.
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Risk assessment of DDI potential of drug candidates using mathematical models.
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Characterization of drug candidates at the preclinical stage from a DMPK perspective
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Preparation & review of nonclinical pharmacokinetic sections for regulatory submissions.
I offer flexible engagement options to meet your specific needs:
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Collaborative integration with your team for a strategic approach.
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Ad hoc consulting for focused support.
Location
Greater Montréal area
Québec, Canada