Agnieszka Zimmermann, Rafał Zimmermann, Robert Szyca
Produkt leczniczy w badaniu klinicznym
Investigational medicinal product in clinical trial
The article presents the principles of production, storage and safety guarantee in application of the investigated medicinal products which result from the provisions of law. The definition of the investigated medicinal product includes products which properties are investigated as well as the ones used for comparative purposes, preparations with new substances as well as the already registered medicines and preparations containing placebo. The supervision over the investigated product should be exercised by a pharmacist and a hospital pharmacy, within the framework of performed pharmaceutical services, should participate in the clinical trials performed in the hospital. The provisions of law do not give however any specific solutions and in practice the role of the hospital pharmacy is not always taken into consideration by the clinical trials’ sponsors and investigators.
Keywords: investigational drug, clinical trials, hospital pharmacy, legislation.