EMA 注射剂就给药剂量指南 2004.6.2 英文.pdf

European Medicines Agency London, 2 June 2004 EMEA/CHMP/QWP/1888/04 CONCEPT PAPER ON THE DEVELOPMENT OF A COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DOSING DELIVERY OF INJECTABLE LIQUIDS Scope and introduction This concept paper addresses the dosing delivery of injectable liquid dosage forms. It may also be applicable to oral delivery systems. It primarily focuses on the manner of graduation of (multidose) syringes and the graduation scale. Other related aspects such as the injectability of liquid suspensions (needle diameter and particle size) may be addressed. Problem statement Some EU member states have granted Marketing Authorisations to injections where the graduation is printed on a label that is glued to the plastic of the syringe, rather than printed on or embossed into the plastic. This approach may cause inaccuracies of dosing, due to lack of precision of the graduation, the exact placement of the label on the syringe, and possible displacement of the label during storage or use. Moreover, the graduation scale should be acceptable in view of prescribed doses. The problem with graduation on syringes is not only theoretical because in daily practice problems have lead to product recalls. Anticipated benefit to industry and other interested parties It is to the benefit of each patient, to receive the prescribed dose with little and reproducible variation. Only when this can be assured, it is possible to establish a clear relationship between the clinical state of the patient and the prescribed dose and unexpected side effects and insufficient