Clinical studies are systematic studies conducted on volunteers in accordance with international rules in order to determine the safe and effective dose and investigate adverse effects. In Phase 1 clinical trials, it is aimed to obtain the safety data of the developed drug. Tolerability and pharmacokinetic properties are examined. Studies are carried in healthy volunteers or in certain types of patients, direct patients for the drugs with potential toxicity such as cytotoxic drugs.
Bioequivalence is the absorption rate and degree, (i.e. bioavailability) effect similarity of the two products containing the same molar dose of the active substance after using. Thus, its therapeutic effects are similar. Bioequivalence studies are studies in which pharmacokinetic (Cmax, tmax, AUC) parameters are compared in a limited number of healthy volunteers and these values are equivalent to a certain extent. In 2021, Bioequivalence studies will be performed in our 24-bed clinic, and Phase 1 Clinical Research will start in Yeditepe University Koşuyolu Hospital in accordance with Good Clinical Practice (GCP).
Refers to analysis of a drug molecule as well as its metabolite(s) using LC and LC-MSMS technologies by an appropriate method in a biological matrix environment (blood, plasma, urine, cerebrospinal fluid (CSF), lymph, etc., all other extracellular fluids (ECF) and interstitial fluid environments)
Our Good Clinical Practices Center is based on the standards of the Turkish Medicines and Medical Devices Agency (TITCK), as well as the World Health Organization (WHO), the European Medicines Agency (EMA), the American Food and Drug Administration (FDA) and the International Compliance Council (ICH).