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.
LINK Medical offers
Clinical 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 nonclinical and clinical phases to regulatory writing, our consultants deliver tailored services to meet your specific challenges.
Nonclinical Phase Services for Drug Development
Our experts provide a comprehensive range of services to smooth your journey through the nonclinical 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 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.
Our expertise includes:
Clinical Phase Services
Our experts excel in delivering targeted services to support the clinical phase of your drug development. We provide strategic planning and advanced pharmacokinetic modelling 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 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.