Research & Innovation
Publications
Pharmazeutische Standards für klinische Studien
PMU Author
Robert Terkola
All Authors
Robert Terkola
Journal association
ONKOLOGIE
Abstract
The procurement, transport, storage, manufacturing or compounding, the application, disposal, documentation, and the quality assurance of investigational medicinal products (IMPs) have to be done according to the pharmaceutical sciences. Medicines related to clinical trials in the European Union are regulated in volume 10 of the EudraLex. The rules for commercially manufactured medicines for human use are not valid for medicines which are individually compounded for a certain patient in the pharmacy. They are also not valid for medicines dedicated for experiments in research and development. The present article describes standards concerning the participation of the pharmacy in clinical trials, the pathway of the drug including the role of the study personnel, and its qualification and training. The issue of stability and compatibility of IMPs is an important topic which may influence the outcome of clinical trials. To avoid quality shifts Standard Operating Procedures (SOPs) have to be established.
Keywords
GERMANY, Clinical Trials as Topic/standards, Drug Compounding/standards, Drug Evaluation/standards, European Union, Guideline Adherence/organization & administration, Pharmacy/standards, Practice Guidelines as Topic, Research/standards