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Clinical Trials of GMP Products in the Gene Therapy Field

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Viral Vectors for Gene Therapy

Part of the book series: Methods in Molecular Biology ((MIMB,volume 737))

Abstract

Advances in gene therapy are increasingly leading to clinical assessment in many fields of medicine with diverse approaches. The basic science stems from approaches aimed at different functions such as correcting a missing/abnormal gene, altering the proportion or expression of normal genes to augment a physiological process or using this principle to destroy malignant or infected cells. As the technology advances, it is increasingly important to ensure that clinical trials answer the questions that need to be asked. In this chapter we review examples of published clinical trials, resources for accessing information about registered trials, the process of regulating trials, good clinical practice, and good manufacturing practice as well as summarising the approach taken by regulatory authorities in reviewing applications for the introduction of products for use in the clinic.

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Author information

Authors and Affiliations

  1. Department of Microbiology, Imperial College Healthcare NHS Trust, London, UK

    Kathleen B. Bamford

  2. Department of Infectious Diseases and Immunity, Imperial College London, London, UK

    Kathleen B. Bamford

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  1. Kathleen B. Bamford
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Correspondence to Kathleen B. Bamford .

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Editors and Affiliations

  1. Généthon, rue de l'Internationale 1, Évry CX 2, 91002, France

    Otto-Wilhelm Merten

  2. Chemical & Bioprocess Engineering, University College Dublin, Belfield, Dublin, 4, Ireland

    Mohamed Al-Rubeai

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Bamford, K.B. (2011). Clinical Trials of GMP Products in the Gene Therapy Field. In: Merten, OW., Al-Rubeai, M. (eds) Viral Vectors for Gene Therapy. Methods in Molecular Biology, vol 737. Humana Press. https://doi.org/10.1007/978-1-61779-095-9_18

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  • DOI: https://doi.org/10.1007/978-1-61779-095-9_18

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  • Publisher Name: Humana Press

  • Print ISBN: 978-1-61779-094-2

  • Online ISBN: 978-1-61779-095-9

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