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Position statements
"Belgian IBD research group (BIRD) position statement 2017 on the use of biosimilars in inflammatory bowel diseases (IBD) "Price: €10,00 |
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Biosimilars are biological drugs which are similar to
the authorized biologics (“reference product”) but not
identical (1). The European legislation has offered since
2006 a legal framework for biosimilars. The concept
and methodology of the comparative investigations
are further treated in the guidelines of the European
Medicines Agency (EMA)(1). A biosimilar is only
authorized when it can be stated with appropriate certainty
that its variability and the differences with the reference
medicinal product will not have a relevant influence on
the safety or efficacy. EMA has approved a first one
biosimilar to infliximab, namely CT-P13 and marketed
with two brand names Remsima (2) and Inflectra (3), on
the basis of two randomized controlled trials (RCT) in
Rheumathoid Arthritis (RA) and Ankylosing Spondylitis
(AS) (4, 5). More recently, a second biosimilar SB2,
Flixabi (6), has been approved/registered and has also
been evaluated in RA (7). [Product Details...] |
The Belgian Association for Study of the Liver Guidance Document on the Management of Adult and Paediatric Non-Alcoholic Fatty Liver DiseasePrice: €10,00 |
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Non-Alcoholic Fatty Liver Disease (NAFLD) is highly prevalent
and associated with considerable liver-related and non-liverrelated
morbidity and mortality. There is, however, a lot of
uncertainty on how to handle NAFLD in clinical practice. The
current guidance document, compiled under the aegis of the
Belgian Association for the Study of the Liver by a panel of experts
in NAFLD, from a broad range of different specialties, covers
many questions encountered in daily clinical practice regarding
diagnosis, screening, therapy and follow-up in adult and paediatric
patients. Guidance statements in this document are based on
the available evidence whenever possible. In case of absence of
evidence or inconsistency of the data, guidance statements were
formulated based on consensus of the expert panel. This guidance
document is intended as a help for clinicians (general practitioners
and all involved specialties) to implement the most recent evidence
and insights in the field of NAFLD within a Belgian perspective.
(Acta gastroenterol. belg., 2018, 81, 55-81). [Product Details...] |
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Acta Gastro-Enterologica Belgica is indexed in NCBI/PubMed.
Printed by Universa Press, Wetteren, Belgium. ©vzw/asbl Acta Gastro-Enterologica Belgica
Printed by Universa Press, Wetteren, Belgium. ©vzw/asbl Acta Gastro-Enterologica Belgica