Nanotherapeutics--product development along the "nanomaterial" discussion.
Nanomaterials have become part of formulation development in the pharmaceutical industry and offer exciting opportunities in the area of targeted drug delivery. But they may also exert unexpected toxicities and potentially pose a threat to human health and the environment. Since the Scientific Committee on Emerging and Newly Identified Health Risks recommended a definition of "nanomaterials" for implementation into the existing and upcoming regulatory framework in the European Union, a discussion about safety requirements of new nanoscale products has emerged. At the same time, the Food and Drug Administration of the United States still observes recent developments in this area. Although the impact on the pharmaceutical product chain is still uncertain, guidelines on risk assessment in food products and cosmetics are available and offer a preview of future developments in the regimens of pharmaceuticals.
Fraunhofer-Institute of Molecular Biology and Applied Ecology (IME), Project group for Translational Medicine & Pharmacology (TMP), Department of Pharmaceutical Technology/Nanosciences, Frankfurt/Main, D-60438, Germany.
Matthias G
MG
Wacker
D000818:Animals; D003358:Cosmetics / Q000737:chemistry / Q000592:standards / Q000633:toxicity; D004339:Drug Compounding / Q000639:trends; D016503:Drug Delivery Systems / Q000009:adverse effects / Q000592:standards / Q000639:trends; D004864:Equipment and Supplies / Q000009:adverse effects; D005062:European Union; D005503:Food Additives / Q000009:adverse effects / Q000737:chemistry / Q000592:standards; D005524:Food Technology / Q000639:trends; D017408:Guidelines as Topic; D006801:Humans; D050997:Nanomedicine / Q000639:trends; D049329:Nanostructures / Q000009:adverse effects / Q000737:chemistry* / Q000592:standards; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
D003358:Cosmetics; D005503:Food Additives
EMA; US FDA; drug delivery systems; government; materials science; nanoparticles; nanotechnology; regulations; regulatory science; toxicity