بایگانی برچسب برای: Pharmaceutical

Dictionary[taliem.ir]

Dictionary of Pharmaceutical Medicine

abbreviated new drug application (ANDA) Application for marketing authorisation if a drug has already received approval under a previous conventional NDA (applicable for generics); important drug properties as e.g. toxicity and safety have therefore already been documented; see also abriged application, approval, accelerated approval program. Aberdeen drug coding system Historic coding system; see code. abriged application EC: “the applicant shall not be required to provide the results of pharmacological and toxicological tests or the results of clinical trials if he can demonstrate: (i) either that the proprietary medicinal product is essentially similar to a product authorized ... and that the person responsible for the marketing of the original product has consented to the ... references contained in the fle being used ... (ii) or by detailed references to published scientifc literature (bibliographical application)... (iii) or that the product is essentially similar to a product which has been authorized within the Community ... for not less than 6 (10) years and is marketed in the Member State for which the application is made ... ; ... where the ... product is intended for a different therapeutic use from that of the other products marketed or is to be administered by different routes or doses, the results of appropriate pharmacological and toxicological tests and/or clinical trials must be provided”; the term is often used synonymously to generic application; see also abbreviated new drug application, accelerated approval program, hybrid procedure.