TY  - JOUR
U1  - Zeitschriftenartikel, wissenschaftlich - begutachtet (reviewed)
A1  - Limaye, Vaidehi
A1  - Fortwengel, Gerhard
A1  - Limaye, Dnyanesh
T1  - Regulatory roadmap for nanotechnology based medicines
JF  - International Journal of Drug Regulatory Affairs
N2  - Nanotechnology is emerging as one of the key technologies of the 21st century and is expected to enable developments across a wide  range of sectors that can benefit citizens.  Nanomedicine is an application   of nanotechnology in the areas  of healthcare, disease diagnosis, treatment and prevention of disease.  Nanomedicines pose problem of  nanotoxicity related to factors like size, shape, specific surface area, surface  morphology, and crystallinity.  Currently, nanomedicines are  regulated as medicinal products or as medical  devices and there is no specific regulatory framework  for nanotechnology-based  products neither in the EU nor  in the USA. This review presents a scheme for classification and regulatory approval process for nanotechnology based medicines.
KW  - Nanotechnology
KW  - Nanomedicine
KW  - Nanotoxicity
KW  - Approval
KW  - Regulations
Y1  - 2014
UN  - https://nbn-resolving.org/urn:nbn:de:bsz:960-opus4-10835
U6  - https://doi.org/10.25968/opus-1083
DO  - https://doi.org/10.25968/opus-1083
VL  - 2014
IS  - 2(4)
SP  - 33
EP  - 41
ER  -