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Estudos de medicamentos biosimilares
(2010-09-01)
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 ...
Biosimilar knowledge and viewpoints among Brazilian inflammatory bowel disease patients
(2021-01-01)
Background: In this analysis we aimed to describe Brazilian inflammatory bowel disease (IBD) patients’ knowledge and perceptions regarding biosimilars and compare with viewpoints from non-Brazilian patients. Methods: An ...
Development Of Biosimilars In Brazil [desenvolvimento De Biossimilares No Brasil]
(OpenJournals Publishing, 2016)
Discontinuation rates following a switch from a reference to a biosimilar biologic in patients with inflammatory bowel disease: A systematic review and meta-analysisTaxas de descontinuação do tratamento após a troca de um biológico originador por um biossimilar em pacientes com doenças inflamatórias intestinais: Revisão sistemática e metanálise.
(2020-07-01)
– Background – Biologics have revolutionized the treatment of inflammatory bowel disease (IBD). However, these drugs had a significant influence on treatment-related costs, which resulted in the development of biosimilars. ...
Development Of Biosimilars In BrazilDesenvolvimento De Biossimilares No Brasil
(OpenJournals Publishing, 2016)
Intercambiabilidad de medicamentos de origen biológico (biofármacos): Consideraciones acerca de la aprobación de formulaciones biosimilares (biogenéricos) en Chile
(2006-12)
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 ...
Human interferon B1 ser17: Coding DNA synthesis, expression, purification and characterization of bioactive recombinant protein
(2010-09-01)
A protocol to produce large amounts of bioactive homogeneous human interferon β1 expressed in Escherichia coli was developed. Human interferon β1 ser17 gene was constructed, cloned and subcloned, and the recombinant protein ...
Regulatory issues on pharmacovigilance in Latin American countries
(Network of Centres for Study of Pharmaceutical Law, 2014)
Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, ...