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Adverse Events with Biomedicines: Prevention Through Understanding
Paperback
ISBN13: 9788847058484
Publisher: Springer
Published: May 4 2017
Pages: 633
Weight: 2.02
Height: 1.33 Width: 6.13 Depth: 9.25
Language: English
This monograph gathers and evaluates data on adverse events (AEs) associated specifically with those biomedicines - monoclonal antibodies, fusion proteins, and cytokines - that have recently entered therapeutic use in humans. All AEs observed when using each member of this new drug class are covered, with a view to improving understanding of pathogenesis, facilitating prevention, monitoring, and control, and contributing to the development of better drugs that provide benefits while minimizing risk. Further aspects here examined include the role of drug mechanisms of action and immunogenicity in relation to AEs outcome and induction of systemic syndromes. Additional data on AEs in off-label treatments are also considered.
Electronic data sheets, downloadable from Springer Extra Materials platform, include more detailed safety data as well as additional basic information on product characteristics, pre- and post-marketing AEs classified according to frequency, and system/organ targeting. Data on excipients and selected information on drug interactions and associations are also provided. Adverse Events with Biomedicines: Prevention Through Understanding will serve as a detailed, practical guideline to this important new area, which demands the attention of clinicians, immunologists, oncologists, allergologists, public health professionals, and drug companies.
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