Pharmacokinetics
ICRC-Weyer has large experience with clinical pharmacokinetic studies conducted throughout phase I, phase II (early and late), and phase III studies to obtain accurate information on the absorption, distribution, metabolism, and excretion of an investigational drug giving consideration to individual variation.
Also in studies after application for marketing authorization and even after approval, ICRC-Weyer has already long experience in designing and conducting pharmacokinetic trials to find out the effects of certain factors such as age, gender, body weight, genetic factors, meals, drinking and smoking habits, concomitant medications, or other factors that may have influence on the pharmacokinetic profiles.
According to the inherent properties of the investigational drug, ICRC-Weyer chooses the most appropriate methods for a more efficient development of your investigational drug taking into consideration all existing information from both nonclinical and clinical studies. ICRC-Weyer will help you to achieve your target avoiding any additional unnecessary studies.
ICRC-Weyer aims always to ensure the safety of subjects, the protection of human rights, the maintenance of scientific quality, and the reliability of results.
ICRC-Weyer experience starts from single-dose studies where the concentration of an investigational drug and its metabolites are measured in blood following a single administration to healthy volunteers or patients. ICRC-Weyer experience extends also to involve as well repeated-dose studies in which changes in pharmacokinetic parameters, confirmation of steady state concentrations, and the potential for accumulation are evaluated upon repeated administration of an investigational drug, across various dosing routes and according to various schedules planned for clinical practice
ICRC-Weyer has already notable achievements in clinical trials with population pharmacokinetic approach which cause less inconvenience and stress on the subjects involved and are considered suitable for special populations such as the elderly and children.
Furthermore, ICRC-Weyer offers a unique PK/PD study design for investigational drugs if there is no direct proportionality between the concentration of the investigational drug in blood and its efficacy e.g. when the efficacy is attained after drug elimination from blood or even long after the drug is bound to the target site.
Being in the German market for more than 20 years, ICRC-Weyer has also designed and conducted several pharmacokinetic studies needed for extrapolating foreign data to Germany in which the data from ethnically diverse populations was compared with the data from German population with due consideration to comparability in all aspects, including study design, study protocol and analytical methods.