Now showing items 11-20 of 29
Development Of Biosimilars In BrazilDesenvolvimento De Biossimilares No Brasil
(OpenJournals Publishing, 2016)
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 ...
Intercambiabilidad de medicamentos de origen biológico (biofármacos): Consideraciones acerca de la aprobación de formulaciones biosimilares (biogenéricos) en Chile
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 ...
Entry strategies into biosimilars: assessment of entry modes into the field of biosimilars from the perspective of pharmaceuticals, generics and biologics companies
Today’s pharmaceutical industry is in transition. As major blockbuster drugs are losing or are about to lose patent protection, and big pharmaceutical companies are not replacing those products with new innovative chemical ...
Human interferon B1 ser17: Coding DNA synthesis, expression, purification and characterization of bioactive recombinant protein
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, ...
Superprodução do interferon β1 humano recombinante em Escherichia coli
(Pontifícia Universidade Católica do Rio Grande do SulPorto Alegre, 2008)
Interferons are proteins expressed by different human cells and synthesized in response to many chemical and biological agents. They are involved in antiviral, antiproliferative and immunomodulatory responses, acting to ...