Pharmacokinetics
ICRC-WEYER has large experience with clinical PK studies conducted throughout phase I - III to obtain accurate information on the absorption, distribution, metabolism, and excretion of an IMP giving consideration to individual variation.
ICRC-WEYER chooses the most appropriate methods for a more efficient development of your IMP taking into consideration all existing information from both nonclinical and clinical studies. Thus ICRC-Weyer will help you to avoid any additional unnecessary studies.
ICRC-WEYER is experienced in designing and conducting PK trials to evaluate the effects of certain factors that may impact the PK profile such as age, gender, body weight, genetic factors, concomitant medication as well as dietary and lifestyle habits. We assign highest priority to the safety of subjects, the protection of human rights, the maintenance of scientific quality and the reliability of results.
ICRC-WEYER experience ranges from single-dose studies to trials with repeated-dose study design across various dosing routes and according to various schedules planned for clinical practice.
ICRC-WEYER has already notable achievements employing a 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 IMPs with no direct proportionality between blood concentration and efficacy
Being in the German market for more than 20 years, ICRC-WEYER has also designed and conducted several PK studies extrapolating foreign data from ethnically diverse populations to Germany.