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 (often summarized in the acronym ADME). ADME studies help the developer understand if a drug candidate can deliver the desired effect.
The purpose of clinical pharmacology is to aid extrapolation (estimation) 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
- organ impairment
- age, race, sex, or weight...
By doing so, accurate treatment recommendations can be given in the label and a positive benefit-risk profile can be achieved.
What we do
Our consultants provide services in the discovery and development phases, both non-clinical and clinical work. They can take a strategic advisory role, or assist in planning, elaborating and reviewing clinical pharmacology and DMPK programs and studies.
When doing pharmacokinetic calculations and interpretations, we use Phoenix WinNonlin®. Phoenix WinNonlin® is the industry-standard software for the analysis of pharmacokinetic and pharmacodynamics data.
Examples of services in the non-clinical phase
Our consultants can help in the design and timing of:
- Strategic planning of the non-clinical phase.
- Drug-drug interaction (DDI, In-vitro interaction)
- Transporter interaction studies
- Bioanalysis of non-clinical samples
- Tissue distribution studies
- Toxico- and pharmacokinetic studies
- Metabolites in safety testing (MIST)
- Mass balance studies
- In-vitro/in-vivo metabolism
Examples of services in the clinical phase
- Strategic planning of the clinical phases.
- Pharmacokinetic modeling & simulation
- Bioanalysis of clinical samples
- Prediction of human pharmacokinetics
- Dose selection/rationale for phase I/first-time-in-human
- Design of phase I studies such as drug-drug interaction, bioavailability, human ADME, bioequivalence, biosimilar, renal and hepatic impairment.
- Food interaction studies
- Biowaiver for clinical studies
- Anti-drug antibody strategy (ADA)
In addition, our consultants provide and take responsibility for expert writing of regulatory documents as well as expert opinions for due diligence and gap analyses.