EMA PUBLISHES GUIDELINES ON DRUGS WITH MODIFIED RELEASE OF ACTIVE SUBSTANCES
October 1st, 2012 BY CARMEN PAUN, IN BRUSSELS THE EUROPEAN Medicines Agency (EMA) has published fresh guidance on assessing medicines releasing active substances slowly into the human body - both oral medicines and skin patches. Taking account of the difficulty of checking the reliability of these medicines, EMA has advised the pharma sector on their development, notably in vitro testing of medicines whose release of active substances is delayed or prolonged. "It should be demonstrated that the prolonged release product maintains its drug release characteristics regardless ...
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