Retrospective evaluation of single patient investigational new drug (IND) requests in pediatric oncology
Sign Up to like & getrecommendations! Published in 2021 at "Cancer Medicine"
DOI: 10.1002/cam4.3791
Abstract: Single patient Investigational New Drug (IND) applications are one mechanism through which experimental therapies are accessed for children with cancer. The landscape of use, outcomes, and toxicity from single patient INDs remains unknown in pediatric… read more here.
Keywords: patient investigational; single patient; new drug; investigational new ... See more keywords
Aggregation and analysis of secondary pharmacology data from investigational new drug submissions at the US Food and Drug Administration.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of pharmacological and toxicological methods"
DOI: 10.1016/j.vascn.2021.107098
Abstract: Secondary pharmacology studies are utilized by the pharmaceutical industry as a cost-efficient tool to identify potential safety liabilities of drugs before entering Phase 1 clinical trials. These studies are recommended by the Food and Drug… read more here.
Keywords: secondary pharmacology; drug administration; drug; pharmacology ... See more keywords
Investigational new drugs for the treatment of Dravet syndrome: an update
Sign Up to like & getrecommendations! Published in 2023 at "Expert Opinion on Investigational Drugs"
DOI: 10.1080/13543784.2023.2193680
Abstract: ABSTRACT Introduction While there are already approved anticonvulsants for treatment of children with Dravet syndrome, disease modifying therapy is at its beginning. Areas covered This narrative review is updating the latest information about efficacy and… read more here.
Keywords: new drugs; investigational new; treatment dravet; dravet syndrome ... See more keywords