Drug Regulators, EMEA, Publish Guideline on Investigations of Medicinal Products in the Treatment of Epileptic Disorders
Drug Regulators, EMEA, Publish Guideline on Investigations of Medicinal Products in the Treatment of Epileptic Disorders
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The present document is a second revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMEA and ICH guidelines, which may apply to these conditions and patient populations.
The clinical development plan of anti-epileptic agents in partial epilepsy in the add-on setting is well-established. Current revision pays more attention to epileptic syndromes, need for studies in the paediatric population, need for monotherapy studies and other special cases.
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