Regulatory challenges of nanomedicines and their follow‐on versions: A generic or similar approach?☆
Sign Up to like & getrecommendations! Published in 2018 at "Advanced Drug Delivery Reviews"
DOI: 10.1016/j.addr.2018.06.024
Abstract: ABSTRACT Nanomedicines and follow‐on versions (also called nanosimilars in the EU) have been on the market partially for decades although without recognition of their nano properties in the beginning; a substantial number is in clinical… read more here.
Keywords: quality; nanomedicines follow; regulatory challenges; approach ... See more keywords
Regulatory considerations for generic products of non-biological complex drugs
Sign Up to like & getrecommendations! Published in 2023 at "Journal of Food and Drug Analysis"
DOI: 10.38212/2224-6614.3441
Abstract: The Non-Biological Complex Drug (NBCD) Working Group defines an NBCD as “a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure, but consists of different (closely related and… read more here.
Keywords: generic products; considerations generic; regulatory considerations; follow versions ... See more keywords