John Wiley & Sons, Ltd.

Nanopharmaceuticals – tiny challenges for the environmental risk assessment of pharmaceuticals

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Many new developments and innovations in health care are based on nanotechnology. The field of nanopharmaceuticals is diverse and not as new as one might think: for many years nanopharmaceuticals have been marketed and future is likely to bring more nanosized compounds to the market. Therefore it is time to examine, whether the environmental risk assessment for human pharmaceuticals is prepared to assess the exposure, fate and effects of nanopharmaceuticals in an adequate way. Challenges are the different definitions for nanomaterials and nanopharmaceuticals, different regulatory frameworks, the diversity of nanopharmaceuticals, the scope of current regulatory guidelines, and the applicability of test protocols. Based on the current environmental risk assessment for human medicinal products in the EU, necessary adaptations for the assessment procedures and underlying study protocols are discussed and emerging solutions identified. This article is protected by copyright. All rights reserved

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