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Eur J Pharm Sci ; 114: 24-29, 2018 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-29191521

RESUMO

BACKGROUND: Pharmaceutical compounding preparations, produced by (hospital) pharmacies, usually do not have marketing authorization. As a consequence, some of these pharmaceutical compounding preparations can be picked-up by a pharmaceutical company to obtain marketing authorization, often leading to price increases. An example is the 3,4-diaminopyridine slow release (3,4-DAP SR) tablets for Lambert-Eaton Myasthenic Syndrome (LEMS). In 2009 marketing authorization was given for the commercial immediate release phosphate salt of the drug, including a fifty-fold price increase compared to the pharmaceutical compounding preparation. Obtaining marketing authorization for 3,4-DAP SR by academia might have been a solution to prevent this price increase. To determine whether the available data of a pharmaceutical compounding preparation with long-term experience in regular care are adequate to obtain marketing authorization, 3,4-DAP SR is used as a case study. METHODS: A retrospective qualitative case-study was performed. Initially, document analysis was executed by collecting the required data for marketing authorization in general and whether data of Firdapse® and 3,4-DAP SR met these requirements. Secondly, the (non-) available data of the two formulations were compared with each other to determine the differences in availability. RESULTS: At the time of approval, almost all data were available for both Firdapse® and 3,4-DAP SR. Conversely, much of the data used for the approval of Firdapse® originated from the 3,4-DAP immediate release (3,4-DAP IR) formulation. Only two bioequivalence studies and one pharmacology safety study was performed with Firdapse® before marketing authorization application. CONCLUSIONS: In conclusion, at time Firdapse® obtained approval, the data available did not differ substantially from 3,4-DAP SR, indicating that approval with 3,4-DAP SR would have been possible. We make a plea for approval of orphan medicinal products developed and manufactured by academic institutions as to keep utilization of these products affordable.


Assuntos
4-Aminopiridina/análogos & derivados , Composição de Medicamentos/métodos , Síndrome Miastênica de Lambert-Eaton/tratamento farmacológico , Marketing/métodos , Produção de Droga sem Interesse Comercial/métodos , 4-Aminopiridina/economia , 4-Aminopiridina/uso terapêutico , Amifampridina , Publicidade Direta ao Consumidor/economia , Publicidade Direta ao Consumidor/legislação & jurisprudência , Publicidade Direta ao Consumidor/métodos , Composição de Medicamentos/economia , Humanos , Síndrome Miastênica de Lambert-Eaton/economia , Marketing/economia , Marketing/legislação & jurisprudência , Produção de Droga sem Interesse Comercial/economia , Produção de Droga sem Interesse Comercial/legislação & jurisprudência , Bloqueadores dos Canais de Potássio/economia , Bloqueadores dos Canais de Potássio/uso terapêutico , Pesquisa Qualitativa , Estudos Retrospectivos
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