Abstract:BackgroundMany unlicensed medicinal products routinely used to treat the paediatric population do not undergo the same rigorous assessment that adult preparations do prior to coming to market. This means that many preparations are not authorised for paediatric use and consequently there is widespread use of unlicensed medicines and ‘off-label’ use of licensed medicines. Evaluation of excipients in unlicensed medicines is an integral part of assessing their suitability for use in paediatric patients.1 Excipient… Show more
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