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 challenges and considerations for the clinical application of CAR T cell therapy
Sign Up to like & getrecommendations! Published in 2021 at "Expert Opinion on Biological Therapy"
DOI: 10.1080/14712598.2021.1887130
Abstract: Chimeric antigen receptor T (CAR T) cell therapy has revolutionized the treatment of relapsed and refractory hematologic malignancies leading to their integration into treatment algorithms. Tisagenlecleucel received the first FDA cellular therapy approval in 2017… read more here.
Keywords: car cell; regulatory challenges; cell therapy; therapy ... See more keywords
Development and Regulatory Challenges for Peptide Therapeutics
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DOI: 10.1177/1091581820977846
Abstract: There has been an increased interest in and activity for the use of peptide therapeutics to treat a variety of human diseases. The number of peptide drugs entering clinical development and the market has increased… read more here.
Keywords: regulatory challenges; challenges peptide; peptide therapeutics; toxicology ... See more keywords
The regulatory challenges of innovative customized combination products
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2022.821094
Abstract: Background/aims Combination products are therapeutic and/or diagnostic products that can combine drugs and medical devices and which increasing complexity has raised new regulatory framework challenges. To reach the market, a combination product must be classified… read more here.
Keywords: challenges innovative; combination; customized combination; combination products ... See more keywords