TY - JOUR
T1 - Environmental hazard testing of nanobiomaterials
AU - Amorim, M. J.B.
AU - Fernández-Cruz, M. L.
AU - Hund-Rinke, K.
AU - Scott-Fordsmand, J. J.
PY - 2020
Y1 - 2020
N2 - The European Medicines Agency (EMA) regards the potential risks of human medicinal products to the environment and their impacts are assessed, as well as management to limit this impact. Hazard assessment of novel materials, which differ from conventional chemicals, e.g. nanobiomaterials, poses testing challenges and represents a work-in-progress with much focus on the optimization of required methodologies. For this work-in-progress, we here highlight where changes/updates are required in relation to the main elements for international testing based on OECD guidelines, supported by knowledge from the nanotoxicity area. The outline describes two major sections, nanobiomaterials and environmental hazards, including its challenges and learned lessons, with recommendations for implementation in OECD guidelines. Finally, the way forward via a testing strategy is described.[Figure not available: see fulltext.].
AB - The European Medicines Agency (EMA) regards the potential risks of human medicinal products to the environment and their impacts are assessed, as well as management to limit this impact. Hazard assessment of novel materials, which differ from conventional chemicals, e.g. nanobiomaterials, poses testing challenges and represents a work-in-progress with much focus on the optimization of required methodologies. For this work-in-progress, we here highlight where changes/updates are required in relation to the main elements for international testing based on OECD guidelines, supported by knowledge from the nanotoxicity area. The outline describes two major sections, nanobiomaterials and environmental hazards, including its challenges and learned lessons, with recommendations for implementation in OECD guidelines. Finally, the way forward via a testing strategy is described.[Figure not available: see fulltext.].
KW - Advanced therapy medicinal products
KW - Medical devices
KW - Nanobiomaterials
KW - Nanomedicine
KW - OECD standardization
UR - https://www.scopus.com/pages/publications/85088303273
U2 - 10.1186/s12302-020-00369-8
DO - 10.1186/s12302-020-00369-8
M3 - Journal article
AN - SCOPUS:85088303273
SN - 2190-4707
VL - 32
JO - Environmental Sciences Europe
JF - Environmental Sciences Europe
IS - 1
M1 - 101
ER -