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Safety Evaluation of Biotechnologically-derived Pharmaceuticals

Facilitating a Scientific Approach

  • Book
  • © 1998

Overview

Editors:
  1. Susan A. Griffiths

    1. Centre for Medicines Research International Carshalton, Surrey, UK

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  2. Cyndy E. Lumley

    1. Centre for Medicines Research International Carshalton, Surrey, UK

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    You can also search for this editor in PubMed   Google Scholar

Part of the book series: Centre for Medicines Research Workshop (CMRW)

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Table of contents (15 chapters)

  1. Front Matter

    Pages i-xviii
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  2. Designing non-clinical safety evaluation programmes: The view of the clinician

    • John Lipani
    Pages 1-6

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

    • Maggie Dempster
    Pages 7-15

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

    • Susan A. Griffiths
    Pages 17-29

  5. Influence of regulatory systems: A viewpoint of the US FDA process

    • Joy A. Cavagnaro
    Pages 31-38

  6. Influence of regulatory systems: The European CPMP perspective

    • Per Sjöberg
    Pages 39-49

  7. Biotechnologically-derived Pharmaceuticals in Japan: Present and future prospects

    • Tohru Inoue
    Pages 51-63

  8. Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: A personal view

    • Douglas M. Morton
    Pages 65-78

  9. Designing non-clinical safety evaluation programmes for interferons and interleukins: A personal view

    • Grushenka H. I. Wolfgang, Sharon Chen, Martin Giedlin, Rene Braeckman, Dale Johnson
    Pages 79-101

  10. Designing non-clinical safety evaluation programmes for monoclonal antibodies for therapeutic use: A personal view

    • Peter Bugelski
    Pages 103-114

  11. Designing non-clinical safety evaluation programmes for gene therapy products: A personal view

    • James MacDonald, Richard Morrissey, James Patrick
    Pages 115-128

  12. Recommendations and the way forward

    • Susan A. Griffiths, Cyndy E. Lumley
    Pages 129-131

  13. Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: Recommendations and the way forward

    • Jennifer Sims, Felix de la Iglesia
    Pages 133-138

  14. Designing non-clinical safety evaluation programmes for interferons and interleukins: Past experiences and recommendations for future products

    • Joy A. Cavagnaro, Timothy Anderson
    Pages 139-149

  15. Designing non-clinical safety evaluation programmes for monoclonal antibodies: Recommendations and the way forward

    • James Green, John Purves
    Pages 151-157

  16. Designing a safety evaluation programme for gene therapy products: Recommendations and the way forward

    • Peter Harris, Anthony Dayan
    Pages 159-167

  17. Back Matter

    Pages 169-200
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Keywords

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.

Editors and Affiliations

  • Centre for Medicines Research International Carshalton, Surrey, UK

    Susan A. Griffiths, Cyndy E. Lumley

Bibliographic Information

  • Book Title: Safety Evaluation of Biotechnologically-derived Pharmaceuticals

  • Book Subtitle: Facilitating a Scientific Approach

  • Editors: Susan A. Griffiths, Cyndy E. Lumley

  • Series Title: Centre for Medicines Research Workshop

  • DOI: https://doi.org/10.1007/978-94-011-4876-4

  • Publisher: Springer Dordrecht

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer Science+Business Media Dordrecht 1998

  • Hardcover ISBN: 978-0-7923-8732-9Published: 30 June 1998

  • Softcover ISBN: 978-94-010-6043-1Published: 13 October 2012

  • eBook ISBN: 978-94-011-4876-4Published: 06 December 2012

  • Edition Number: 1

  • Number of Pages: XVIII, 200

  • Topics: Pharmacology/Toxicology, Medical Law, Public Health

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