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Manufacturing and Safety Guidelines for Manufactured Functionalized Nanomaterials in Pharmaceutics

: Wacker, M.G.; Janas, C.; Ferreira, F.S.; Vieira, F.P.


Sarmento, B.:
Biomedical Applications of Functionalized Nanomaterials : Concepts, Development and Clinical Translation
Amsterdam: Elsevier, 2018 (Micro & Nano Technologies Series)
ISBN: 978-0-323-50879-7
ISBN: 978-0-323-50878-0
ISBN: 0-323-50879-0
Aufsatz in Buch
Fraunhofer IME ()

Today, nanotechnology is widely applied by the pharmaceutical industry. Creating a new generation of products, there have been many concerns about the safety of these engineered functional nanomaterials some of which were used as diagnostics or in drug therapy. The regulatory authorities evaluated a wide range of analytical techniques to define the standards under which manufacture and approval of new nanomedicines may be granted. This chapter will summarize the most important regulatory approaches and define critical quality attributes for the manufacture and characterization of nanomaterials.