Centre for Medicines Research Workshop

Safety Evaluation of Biotechnologically-derived Pharmaceuticals

Facilitating a Scientific Approach

Editors: Griffiths, Susan A., Lumley, Cynthia (Eds.)

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About this book

Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline `Safety Studies for Biotechnological Products', which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.

Table of contents (15 chapters)

  • Designing non-clinical safety evaluation programmes: The view of the clinician

    Lipani, John

    Pages 1-6

  • Designing non-clinical safety evaluation programmes: The view of the toxicologist

    Dempster, Maggie

    Pages 7-15

  • Company strategies for designing non-clinical safety evaluation programmes: Results of a CMR International survey

    Griffiths, Susan A.

    Pages 17-29

  • Influence of regulatory systems: A viewpoint of the US FDA process

    Cavagnaro, Joy A.

    Pages 31-38

  • Influence of regulatory systems: The European CPMP perspective

    Sjöberg, Per

    Pages 39-49

Buy this book

eBook $109.00
price for USA in USD (gross)
  • ISBN 978-94-011-4876-4
  • Digitally watermarked, DRM-free
  • Included format: PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $179.99
price for USA in USD
  • ISBN 978-0-7923-8732-9
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $149.99
price for USA in USD
  • ISBN 978-94-010-6043-1
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Safety Evaluation of Biotechnologically-derived Pharmaceuticals
Book Subtitle
Facilitating a Scientific Approach
Editors
  • Susan A. Griffiths
  • Cynthia Lumley
Series Title
Centre for Medicines Research Workshop
Copyright
1998
Publisher
Springer Netherlands
Copyright Holder
Springer Science+Business Media Dordrecht
eBook ISBN
978-94-011-4876-4
DOI
10.1007/978-94-011-4876-4
Hardcover ISBN
978-0-7923-8732-9
Softcover ISBN
978-94-010-6043-1
Edition Number
1
Number of Pages
XVIII, 200
Topics