Now showing items 1-10 of 526
Investigación y desarrollo de nuevos medicamentos: de la molécula al fármaco
(Sociedad Médica de Santiago, 2001)
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 ...
Drug-resistance mechanisms and tuberculosis drugs
Biological and nonbiological complex drugs for multiple sclerosis in Latin America: Regulations and risk management
(Taylor & Francis, 2015)
Biological drugs and nonbiological complex drugs with expired patents are followed by biosimilars and follow-on drugs that are supposedly similar and comparable with the reference product in terms of quality, safety and ...
Adverse Drug Events Related To Approved Prophylactic Use of Omeprazole
(Adis Int Ltd, 2015-10-01)
Interchangeability of biological drugs: Considerations about the approval of biogeneric formulations in Chile Intercambiabilidad de medicamentos de origen biológico (biofármacos): Consideraciones acerca de la aprobación de formulaciones biosimilares (biog
Once drug patents expire, the health authorities can approve the registry of similar products. They must request to the manufacturer, the bibliographic background of the original product and the analytical results that ...