Search results for risk

EORTC continues to support the appropriate treatment of adult patients with G-CSF to prevent febrile neutropenia: guideline updates

Abstract:  The European Organisation for Research and Treatment of Cancer (EORTC) has updated its 2006 guideline on the use of granulocyte colony-stimulating factor (G-CSF) for the prevention of febrile neutropenia (FN), a sometimes fatal condition in which a loss of neutrophils in patients receiving chemotherapy leads to infections and fever. The guideline provides recommendations on […]

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New CHMP guideline on immunogenicity of monoclonal antibodies

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: The importance of monoclonal antibodies as a product class and the challenge of assessing unwanted immunogenicity for these products have prompted the drafting of a new CHMP (Committee for Medicinal Products for Human Use) guideline. The ‘Guideline on immunogenicity assessment of […]

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A bioethicist’s view of the use of biosimilars

Abstract:  In recognition of the many ethically sensitive issues raised by the production and use of biosimilar medicinal products, the author imagines having to answer the non-multiple choice question ‘From the ethical point of view, what is the most important issue raised by biosimilars?’, and endeavours to explain why the proposed answer is ‘safety’. Submitted: […]

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