Legislación sobre autorización de genéricos
Reads0
Chats0
TLDR
Although mechanisms of price regulation and financing policy are different throughout the member States, most countries have introduced measures to reduce the increase in expenditure on medicines, with generic products being an important aspect since they are less expensive than innovating medicines.About:
This article is published in Farmacia Hospitalaria.The article was published on 2006-11-01 and is currently open access. It has received 8 citations till now. The article focuses on the topics: European union.read more
Citations
More filters
Journal ArticleDOI
Risks and benefits of generic antiepileptic drugs.
TL;DR: High methodological comparative studies are necessary to obtain scientific evidence on the potential risks and benefits of interchanging branded and generic antiepileptic drugs, which could bring consensus about the role of generic drugs for treating epilepsy.
Journal ArticleDOI
Estudio de bioequivalencia del ibuprofeno 400 mg tabletas
Ofelias Villalva-Rojas,Miguel Grande-Ortiz,Juan Ortiz,Jacqueline Isasi,Dula Yantas,Victor Fiestas +5 more
TL;DR: Las muestras de plasma se analizaron por cromatografia liquida acoplada al espectrofotometro de masas (LC-MS/MS) with ionizacion electrospray ion negativo, aplicando monitoreo de reaccion selectiva en velocidad y cantidad de ibuprofeno absorbido en el organismo.
Journal ArticleDOI
Comparación de la equivalencia terapéutica de dos productos de bisoprolol – hidroclorotiazida en pacientes con hipertensión arterial
Ulises Leal,David Rincón +1 more
TL;DR: La formulacion test of the equivalencia terapeutica de dos marcas comerciales de bisoprolol -hidroclorotiazida como terapia antihipertensiva similar al compararla con la formulación de referencia islámica islómica se logro en ambas formULaciones.
Equivalencia terapéutica de tabletas de diazepam dispensadas en la ciudad de Ica, Perú. Therapeutic equivalency of tablets of diazepam dispended in the city of Ica, Peru.
TL;DR: La equivalencia terapeutica in vitro de tres formulaciones de diazepam no es equivalente al medicamento de referencia dado que no se pudo demostrar su intercambiabilidad, la que si se logro establecer para los medicamentos genericos A y B.
References
More filters
Journal ArticleDOI
Understanding the Scientific Issues Embedded in the Generic Drug Approval Process
TL;DR: The major scientific issues embedded in the generic drug approval process and the issues surrounding bioequivalence are reviewed to understand why the process works and why many clinicians and consumers remain uninformed.
Real Decreto 223/2004, de 6 de febrero, por el que se regulan los ensayos clínicos con medicamentos
TL;DR: In this paper, the authors present a set of guidelines for the ensayos clínicos of Investigación Clínica (IC) for menores and women.
Journal ArticleDOI
Genéricos: ¿buenos o malos? Conocimientos y actitudes de los médicos ante los medicamentos genéricos
TL;DR: In this paper, the responses of 1220 Spanish physicians who participated in a survey about generic drugs were analyzed and the influence of physician-related variables (age, type of contract, specialty, workload etc.) on prescribing of generic drugs was also analyzed.
Journal ArticleDOI
Los medicamentos en la Unión Europea: el tándem comercio-salud
TL;DR: In this paper, the pharmaceutical market of the EU was characterized and EU countries were classified into two principal groups according to five selected variables, and EU regulations tend to promote R + D and drug production and thus the EU industrial sector is backed up National regulations differ in terms of pricing and drugs reimbursement.