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Six years of progress in the oral biopharmaceutics area – A summary from the IMI OrBiTo project
European Journal of Pharmaceutics and Biopharmaceutics, 2020 OrBiTo was a precompetitive collaboration focused on the development of the next generation of Oral Biopharmaceutics Tools. The consortium included world leading scientists from nine universities, one regulatory agency, one non-profit research ...
Anette Müllertz +2 more
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Towards the development of a paediatric biopharmaceutics classification system: Results of a survey of experts [PDF]
International Journal of Pharmaceutics, 2016 The aim of this research survey was to understand current global thinking around the need for and development of a paediatric biopharmaceutics classification system (pBCS) to be used for the development of paediatric medicines and regulatory purposes (e ...
Sandra Klein +2 more
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Paediatric biopharmaceutics classification system: Current status and future decisions
International Journal of Pharmaceutics, 2014 Biopharmaceutical methods are routinely used in the design of medicines to predict in vivo absorption and hence guide the development of new products.
Hannah Batchelor
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Theranostic of biopharmaceuticals
Pharmacology & Therapeutics, 2017Monoclonal antibodies (mAbs) and fusion proteins with an Fc portion of immunoglobulin G (IgG) are emblematic of the remarkable expansion of biopharmaceuticals. Despite their biological origin, these products display an interindividual variability in their efficacy and/or side effects, which must be taken into consideration.
Benjamin, Chaigne, Hervé, Watier
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Pharmacovigilance of Biopharmaceuticals
Drug Safety, 2009Biopharmaceuticals are important treatment options for a variety of chronic and sometimes life-threatening diseases. Compared with the traditional small molecule drugs, biopharmaceuticals have specific characteristics, which might also influence their safety profile.
Giezen, Thijs J +2 more
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The immunogenicity of biopharmaceuticals
Neurology, 2003The medical use of proteins has a long history. It started more than one century ago when immune sera of animal origin were introduced for the prevention or treatment of infections, followed by the use of insulin of porcine and bovine origin some decades later.
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On the acceptability of biopharmaceuticals
Science and Engineering Ethics, 1996The issues relating to the licensing of a biopharmaceutical are described. In particular attention is focused on the mind of the regulator who has the responsibility of recommending licensure. There are two key factors which operate on the mind when confronted with such a task: psychology and ethics.
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Current Opinion in Biotechnology, 2000
The rapid maturation of the field of biopharmaceutical formulation is the result of the simultaneous development of a thermodynamic mechanism for protein-solvent interaction and identification of natural chemicals employed by nature to stabilize proteins in response to environmental stresses.
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The rapid maturation of the field of biopharmaceutical formulation is the result of the simultaneous development of a thermodynamic mechanism for protein-solvent interaction and identification of natural chemicals employed by nature to stabilize proteins in response to environmental stresses.
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Advanced Healthcare Materials, 2017 Polymeric microstructures encapsulating biopharmaceutics must be fabricated in a controlled environment to preserve the biological activity. There is increasing demand for simple methods designed to preserve the biological activity by utilizing the ...
Huisuk Yang, Hyungil Jung, Geonwoo Kang
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2015
Biopharmaceutics is the field that investigates and describes everything that happens with a medicinal product and the active substance between the moment of administration, the moment it exerts its action and the moment it is eliminated from the body. Biopharmaceutics connects the physico-chemical properties of an active substance and its dosage form ...
Frijlink, Erik +2 more
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Biopharmaceutics is the field that investigates and describes everything that happens with a medicinal product and the active substance between the moment of administration, the moment it exerts its action and the moment it is eliminated from the body. Biopharmaceutics connects the physico-chemical properties of an active substance and its dosage form ...
Frijlink, Erik +2 more
openaire +1 more source