GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 2 / Year 2013 / Issue 1
Guidelines
EORTC continues to support the appropriate treatment of adult patients with G-CSF to prevent febrile neutropenia: guideline updates
Author(s): GaBI Journal Editor
Page: 47-8Abstract: 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 […]
New CHMP guideline on immunogenicity of monoclonal antibodies
Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath
Page: 45-6Author 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 […]
