Characterization – but how ?

Characterization – but how? Due to the fast progress in the field and the lack of robust datasets, only limited guidance on regulatory information needs is currently available, and the question remains whether the identified requirements in this initial guidance are sufficient for a reliable characterization and assessment of all nanotechnology-enabled health products. In order to generate the required information on the quality, safety, and efficacy of the products, standardized testing methods have to be available. However, many conventional methods may not be suitable or reliable for nanomaterial testing, for example, due to the interference of nanomaterial with assay components. On the other hand, new state-of-the-art methods, instruments, approaches, or tools have not yet sufficiently proven their reliability and relevance for the given purpose.