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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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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DOI: https://doi.org/10.1007/978-3-7643-8679-5_16
Publisher Name: Birkhäuser Basel
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