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Formulation and Administration of Biological Medicinal Products”
Pharmaceutical Research, 2020Monoclonal antibody (Mabs) containing medicinal products are widely used in clinical practice. Prior to parenteral administration, licensed Mab containing medicinal products are transferred to the ready-to-administer (RTA) forms. Reconstitution and/or preparation should follow the guidelines for Good Reconstitution/Good Preparation Practice ...
Irene, Krämer +2 more
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Global Vision about the Biological Medicinal Products: Biosimilars (April, 2009)
Current Pharmaceutical Biotechnology, 2009The prime difference between generics and biosimilars is that while generics contain the exact active ingredient as in the originator product, biosimilars are only "similar" and not "identical" to the originator biological medicine. This difference appears due to the nature of the biopharmaceutical medicines which are extremely complex to manufacture ...
Leyre, Zuñiga, Begoña, Calvo
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Similar biological medicinal products: lessons learned and challenges ahead
Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, 2011The first similar biological medicinal products (or biosimilars) were approved in the European Union (EU) in 2006 in accordance to a regulatory framework published by the European Commission in 2003 and 2004. The term ‘similar biological’ or biosimilar was preferred instead of the term ‘biogeneric’ as, in contrast to small molecules in chemical drugs,
Sol Ruiz, Gonzalo Calvo
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2009
Products such as vaccines, serums, toxins, allergen products and medicinal products derived from human blood or plasma; → see also biopharmaceutical, establishment licence application.
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Products such as vaccines, serums, toxins, allergen products and medicinal products derived from human blood or plasma; → see also biopharmaceutical, establishment licence application.
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International reference preparations for standardization of biological medicinal products
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, 2014International standards are prepared as materials assigned an arbitrary unitage for a biological activity by the Expert Committee on Biological Standardization of the World Health Organization. Working reference materials are calibrated against international standards giving a common unit of measurement between laboratories. The references are assessed
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[Viral safety of biological medicinal products].
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 2015Viral safety of blood donations, plasma products, viral vaccines and gene therapy medicinal products, biotechnical-derived products and tissue and cell therapy products is a particular challenge. These products are manufactured using a variety of human or animal-derived starting materials and reagents; therefore, extensive testing of donors and of cell
A, Stühler, J, Blümel
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PCMO L01--Setting Specifications for Biological Investigational Medicinal Products
PDA Journal of Pharmaceutical Science and Technology, 2015This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10).
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Drug Safety, 2014
Package inserts that accompany medicines are a common source of information aimed at patients and should match patient abilities in terms of readability.Our objective was to determine the degree of readability of the package inserts for biological medicinal products commercially available in 2007 and compare them with the readability of the same ...
Ma Ángeles, Piñero-López +3 more
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Package inserts that accompany medicines are a common source of information aimed at patients and should match patient abilities in terms of readability.Our objective was to determine the degree of readability of the package inserts for biological medicinal products commercially available in 2007 and compare them with the readability of the same ...
Ma Ángeles, Piñero-López +3 more
openaire +2 more sources