Dalle Q&A EMA di maggio 2015 – Usability Study – sui dispositivi per l’erogazione di farmaci oftalmici:
“The functional aspects of plastic containers for eye drops products should be qualified as part of development pharmaceutics, incorporating the usability engineering design principles (Annex I Medical Devices Directive 2007/47/EC; BS EN 62366: 2008 Medical Devices – Application of usability engineering to medical devices).
These functional aspects should include usability, dose delivery performance, the controls for quality of the container and rationale for choice and optimisation of the design, including size and shape of the container closure system. It is known that the size and shape of the container can affect ease of handling and dispensing of drops by patients, especially those with impaired dexterity such as the elderly.
Usability, i.e. that the container can be used safely to deliver the required dose by the target patient population or representative subject group, should be discussed for all eye drop medicinal products.
It is recommended that a formal usability study is undertaken, in accordance with a valid protocol to systematically observe and evaluate the usability of the eye drop medicinal product, particularly for novel containers and containers that are required to be used in a specific (non-intuitive) way. The usability study may be integrated into clinical or therapeutic equivalence studies. In the absence of such study data, evidence of usability should be supported by published or other data, if available, and risk assessment.”
BIOCHEM SNC è in grado di realizzare, rapidamente, un protocollo approvato dagli Enti Regolatori nazionali (AIFA) ed europei per rispondere a quanto richiesto dalla normativa in termini di utilizzo in sicurezza (usability e dose delivery), dei dispositivi utilizzati per la somministrazione di farmaci ad uso oftalmico.
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