EN 
FR 
Clinical Pharmacology, Drug Metabolism & Pharmacokinetics (DMPK)
Cytel can ensure that your drug achieves its intended therapeutic effect and meets regulatory standards with our comprehensive clinical pharmacology, drug metabolism, and pharmacokinetics (DMPK) services.
A Fundamental Part of the Drug Label
The clinical pharmacology, drug metabolism, and pharmacokinetics (DMPK) package is crucial for understanding whether a drug has the right properties and desired effect. It is a fundamental part of the drug label, describing how to use the medical product.
Pharmacology and pharmacokinetics are the scientific fields that study how drugs affect the body and how the body affects the absorption, distribution, metabolism, and excretion of substances (ADME). ADME helps your development team understand if a drug candidate can deliver the desired effect.
Our clinical pharmacology experts work with you to aid extrapolation of the clinical study data to the whole population by identifying populations and situations at risk for under- or overdosing, such as drug-drug interactions, pharmacogenetics, organ impairment, age, race, sex, or weight.
Contact usClinical pharmacology and DMPK expertise
We ensure optimal drug properties and effects, critical for guiding usage instructions for drug labels.
ADME and pharmacokinetics analysis
By studying how the body processes drugs, we help you predict efficacy and safety across diverse patient profiles.
Risk assessment and dosing precision
Identify risk factors for under- or overdosing based on drug interactions, genetics, and patient demographics, to enhance treatment efficacy.
Comprehensive pharmacology support
From strategic planning in non-clinical and clinical phases to regulatory writing, our consultants deliver tailored services to meet your specific challenges.
Non-Clinical Phase Services for Drug Development
Our experts provide a comprehensive range of services to smooth your journey through the non-clinical phase of drug development. We specialize in the strategic planning and timing of various critical studies, including drug-drug interaction (DDI) and transporter interaction studies.
Our expertise includes bioanalysis of non-clinical samples, tissue distribution, and both toxicokinetic and pharmacokinetic analyses. We can also conduct metabolites in safety testing (MIST), mass balance studies, and assessments of in-vitro and in-vivo metabolism. Our services ensure you have a robust foundation for transitioning into the clinical stages of development, optimizing your drug’s safety and efficacy from the outset.
Expertise Across the Clinical Phase
Our experts excel in delivering targeted services to support the clinical phase of your drug development. We provide strategic planning and conduct advanced pharmacokinetic modeling and simulation, as well as bioanalysis of clinical samples and precise predictions of human pharmacokinetics.
We are skilled in dose selection and rationale for Phase I/first-in-human studies, focusing on factors like drug-drug interaction, bioavailability, human ADME, bioequivalence, and considerations for renal and hepatic impairments.
Additionally, we can manage your food interaction studies, biowaivers for clinical phases, and anti-drug antibody strategies (ADA). Our team also specializes in the expert writing of regulatory documents and providing opinions, ensuring due diligence and gap analyses.
The Road to First-in-Human Trials: Insights from a Real-World Example
In this webinar, co-hosted by our client Dicot AB, we explored their path to the first-in-human trial. We discussed navigating drug development, regulatory strategy and decision-making, authority communication, and adhering to regulatory guidelines.
Watch the webinar
Related Insights
PBPK Modeling and Simulation: A Transformative Tool for Early-Stage Clinical Development
Understanding Clinical Pharmacology: From Strategic Studies to Product Labeling
How to Save Time and Limit Costs toward First-in-Human Clinical Trials
Claim your free 30-minute strategy session
Book a free, no-obligation strategy session with a Cytel expert to get advice on how to improve your drug's probability of success and plot a clearer route to market.