Phase I clinical trial
Alignment of analytical methods
Pharmacokinetics is the study of the movement and action of drugs in the body over a period of time. These studies typically take place during phase I clinical trials.
Pharmacokinetic studies (sometimes abbreviated as PK studies) are divided into several areas, commonly referred to as ADME:
- Absorption: Absorption is the process whereby a substance enters the blood circulation.
- Distribution: Distribution is the dispersion or dissemination of substances throughout the fluids and tissues of the body.
- Metabolism: Metabolism is the irreversible transformation of the substance into daughter metabolites.
- Excretion: Excretion is the elimination of the substance from the body.
Most drugs are processed by the body and eliminated through first order kinetics. This relationship enables us to calculate the half-life of the drug.
We take advantage of our knowledge about your molecule, acquired during drug substance characterization. We align the methods for determination and quantification of the active pharmaceutical ingredient and related substances in blood and urine with the stability-indicating method developed for the drug substance.
Is optimization needed? We use our quality-by-design approach to guarantee a robust analytical method. Beyond this, we develop one method for quantification of the compounds in all drug products AND blood, serum or plasma.
Anabiotec will advise you and generate your pharmacokinetic data!