Now showing items 1-10 of 97
Estudos de medicamentos biosimilares
In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acronym in Portuguese) is fully satisfied with the evidence of their quality, efficacy and safety, presented by a pharmaceutical ...
Comparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MS
Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Hoffmann-La Roche Ltd., Switzerland) vs. generic (Lipiblock®, EMS-Sigma Pharma, a generic drug) were carried out with ethanol ...
Generic drugs in Brazil: historical overview and legislation
(PAN AMER HEALTH ORGANIZATION, 2010)
The Brazilian generic drugs policy was implemented in 1999 with the aim of stimulating competition in the market, improve the quality of drugs and improve the access of the population to drug treatment. The process of ...
Access to drugs and the situation of the pharmaceutical market in Ecuador [Acceso a medicamentos y situación del mercado farmacéutico en Ecuador]
(PAN AMERICAN HEALTH ORGANIZATION, 2018)
Farmacovigilância no Brasil: A relação entre polimorfismo de fármacos, efetividade e segurança dos medicamentos
In spite of the stated Brazilian policy on medicines that their quality, effectiveness and safety should be ensured at reasonable cost, hospitals in the ANVISA Surveillance Network have been receiving notifications of ...
Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study ...
US Food and Drug Administration approval of generic versions of complex biologics: implications for the practicing physician using low molecular weight heparins
Low-molecular-weight heparins (LMWHs) have shown equivalent or superior efficacy and safety to unfractionated heparin as antithrombotic therapy for patients with acute coronary syndromes. Each approved LMWH is a pleotropic ...
Diferenças de preços entre medicamentos genéricos e de referência no Brasil
(Faculdade de Saúde Pública da Universidade de São Paulo, 2006-06-01)
OBJECTIVE: To assess the magnitude of price difference between generic and innovator medicines and to evaluate the effect of the price competition between them. METHODS: From January 2000 to June 2004, 135 generic medicines ...