C Bardin

Stability studies performed by the pharmaceutical industry are only designed to fulfil licensing requirements. When medicines are being licensed, little attention is given to the practical use of these drugs and there is no recognition that pharmaceuticals start a new life once they are prepared for patient administration. When reviewing package inserts, the general assumption is that a drug, will be reconstituted, if necessary, and administered on a clinical ward.

Stability studies performed by the pharmaceutical industry are only designed to fulfil licensing requirements. Thus post-dilution or reconstitution stability data are frequently limited to 24 h only for bacteriological reasons, regardless of the true chemical stability, which could, in many cases, be longer.