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PEGylated Protein Drugs: Basic Science and Clinical Applications pp 273–281Cite as

Regulatory strategy and approval processes considered for PEG-drug conjugates and other nanomedicines

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Part of the book series: Milestones in Drug Therapy ((MDT))

Abstract

Therapeutic products prepared by PEG conjugation currently undergo the same regulatory scrutiny as small molecule drugs. A brief review of historical and current regulatory submission strategies is dis cussed in this chapter. In addition, some forward looking suggestions and considerations are made for nanomedicines that employ PEG and other polymers.

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Author information

Authors and Affiliations

  1. Serina Therapeutics, Inc., 601 Genome Way, Huntsville, AL, 35806, USA

    Tacey X. Viegas

  2. Department of Pharmaceutical Sciences, University of Padua, Via F.Marzolo 5, 35131, Padua, Italy

    Francesco M. Veronese

Authors
  1. Tacey X. Viegas
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  2. Francesco M. Veronese
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Editor information

Editors and Affiliations

  1. Department of Pharmaceutical Sciences, University of Padova, 35131, Padova, Italy

    Francesco M. Veronese

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© 2009 Birkhäuser Verlag/Switzerland

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Viegas, T.X., Veronese, F.M. (2009). Regulatory strategy and approval processes considered for PEG-drug conjugates and other nanomedicines. In: Veronese, F.M. (eds) PEGylated Protein Drugs: Basic Science and Clinical Applications. Milestones in Drug Therapy. Birkhäuser Basel. https://doi.org/10.1007/978-3-7643-8679-5_16

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