Nanopharmaceuticals: Tiny challenges for the environmental risk assessment of pharmaceuticals.
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; indeed, nanopharmaceuticals have been marketed for many years, and the 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 include 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 European Union, necessary adaptations for the assessment procedures and underlying study protocols are discussed and emerging solutions identified.
Washing and Cleansing Agents and Nanomaterials, Unit IV2.2 Pharmaceuticals, Federal Environment Agency, Dessau, Germany.
Silvia
S
Berkner
Washing and Cleansing Agents and Nanomaterials, Unit IV2.2 Pharmaceuticals, Federal Environment Agency, Dessau, Germany.
Kathrin
K
Schwirn
Washing and Cleansing Agents and Nanomaterials, Unit IV2.2 Pharmaceuticals, Federal Environment Agency, Dessau, Germany.
Doris
D
Voelker
D064420:Drug-Related Side Effects and Adverse Reactions; D004785:Environmental Pollutants / Q000633:toxicity*; D005062:European Union; D006801:Humans; D049329:Nanostructures / Q000633:toxicity*; D018570:Risk Assessment
D004785:Environmental Pollutants
Environmental risk assessment; Medicinal nanoparticles; Nanomaterials; Nanomedicine; Nanopharmaceuticals