- Key words: stable isotopes, drugs, clinical trials, quality, control.
- Page(s) : 149-52
- Published in: 1998
Stable isotopically labeled compounds used in clinical research are considered as investigational medicinal products. Thus, they are submitted to the relevant legislation which includes their pharmaceutical quality and management. With respect to the specificity of those products (raw materials manufactured by non pharmaceutical companies, high cost...), an appropriate guideline for hospital pharmacists has been elaborated. It gives guidance on the specifications defined by the pharmacist, and on the content of the product specification file completed by the provider. It also describes the main lines for the evaluation of chemical and microbiological purities of the labeled product based on the specification file, the quality controls of raw materials after delivery (at least identification and abnormal toxicity assays), the conditions of storage of raw material and final product samples retained by the hospital pharmacist, and the critical controls of the final products (quantitation...). Up to date, this procedure has been implemented by several hospital pharmacists for the purchase, the evaluation of the quality and the control of stable isotope labeled compounds under clinical trials.