title: Nanoparticles in medicine: Current challenges facing inorganic nanoparticle toxicity assessments and standardizations.
abstract: Although nanoparticles research is ongoing since more than 30years, the development of methods and standard protocols required for their safety and efficacy testing for human use is still in development. The review covers questions on toxicity, safety, risk and legal issues over the lifecycle of inorganic nanoparticles for medical applications. The following topics were covered: (i) In vitro tests may give only a very first indication of possible toxicity as in the actual methods interactions at systemic level are mainly neglected; (ii) the science-driven and the regulation-driven approaches do not really fit for decisive strategies whether or not a nanoparticle should be further developed and may receive a kind of "safety label". (iii) Cost and time of development are the limiting factors for the drug pipeline. Knowing which property of a nanoparticle makes it toxic it may be feasible to re-engineer the particle for higher safety (safety by design).
  
  
  BACKGROUND
  Testing the safety and efficacy of nanoparticles for human use is still in need of standardization. In this concise review, the author described and discussed the current unresolved issues over the application of inorganic nanoparticles for medical applications.
authors.affiliation: MatSearch Consulting, Pully, Switzerland.
authors.forename: Margarethe
authors.initials: M
authors.lastname: Hofmann-Amtenbrink
authors.affiliation: Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah, Salt Lake City, UT, USA.
authors.forename: David W
authors.initials: DW
authors.lastname: Grainger
authors.affiliation: Ecole Polytechnique Fédérale de Lausanne, Institute of Materials, Powder Technology Laboratory, Station 12, Lausanne, Switzerland. Electronic address: heinrich.hofmann@epfl.ch.
authors.forename: Heinrich
authors.initials: H
authors.lastname: Hofmann
mesh_terms: D016503:Drug Delivery Systems / Q000009:adverse effects / Q000592:standards; D006801:Humans; D007287:Inorganic Chemicals / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D050997:Nanomedicine; D053758:Nanoparticles / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*
chemical_list: D007287:Inorganic Chemicals
keywords: Nanomedicine; Nanoparticles; Regulation; Standardization; Toxicity