Zobrazeno 1 - 9
of 9
pro vyhledávání: '"DONNA L. SNYDER"'
Publikováno v:
Therapeutic Innovation & Regulatory Science. 55:282-303
Placebo-controlled trials are the most rigorous method of evaluating the safety and efficacy of investigational treatments, yet the use of a placebo control in pediatric drug development is challenging and potentially controversial. Regulations provi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::3929edaf06792e55440c16eb3f54849a
https://doi.org/10.1007/s43441-020-00214-3
https://doi.org/10.1007/s43441-020-00214-3
Autor:
Melanie E. Bhatnagar, Donna L. Snyder
Publikováno v:
Pediatric Cancer Therapeutics Development ISBN: 9783031063565
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9e1305283d26fac06c386ca9e8d2c4d0
https://doi.org/10.1007/978-3-031-06357-2_11
https://doi.org/10.1007/978-3-031-06357-2_11
Publikováno v:
Frontiers in Pediatrics
Frontiers in Pediatrics, Vol 9 (2021)
Frontiers in Pediatrics, Vol 9 (2021)
The regulatory framework for considering the fetal effects of new drugs is limited. This is partially due to the fact that pediatric regulations (21 CFR subpart D) do not apply to the fetus, and only US Health and Human Service (HHS) regulations appl
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2028c66daf822c12c0a6428630b88f9e
http://europepmc.org/articles/PMC8350126
http://europepmc.org/articles/PMC8350126
Autor:
Edward M. Connor, Robert M. Nelson, Christina Bucci-Rechtweg, Dionna J Green, Ronald J. Portman, Thomas Miller, Gary J. Noel, Carmen Moreno, Donna L. Snyder, Collin Hovinga
Publikováno v:
Therapeutic Innovation & Regulatory Science
Including adolescents in adult clinical trials can play an important role in making innovative new medicines available to children in a timelier fashion. Stakeholders involved in the processes leading to regulatory approval and labeling of new drugs
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::52aa61ad078b0a88f730d1431a425a1f
https://pubmed.ncbi.nlm.nih.gov/33811302
https://pubmed.ncbi.nlm.nih.gov/33811302
Publikováno v:
Therapeutic innovationregulatory science. 55(2)
Placebo-controlled trials are the most rigorous method of evaluating the safety and efficacy of investigational treatments, yet the use of a placebo control in pediatric drug development is challenging and potentially controversial. Regulations provi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::a938bf2c63cf0e973d9d744bb372d3f8
https://pubmed.ncbi.nlm.nih.gov/32901443
https://pubmed.ncbi.nlm.nih.gov/32901443
Autor:
Donna L. Snyder, Robert M. Nelson
Publikováno v:
The American Journal of Bioethics. 18:10-12
Olszewski and Goldkind's (2018) article on pediatric decision making in the clinical care setting is articulate and well written. The authors understand the challenges in ensuring that pediatric pa...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::191a3a0b52f65f1a02b29a73a2a817fd
https://doi.org/10.1080/15265161.2017.1418938
https://doi.org/10.1080/15265161.2017.1418938
Publikováno v:
Ethics and Research with Children
The “Additional Safeguards for Children in FDA-Regulated Clinical Investigations,” 21 CFR 50 subpart D, places limits on the risk to which a child can be exposed in a study. Absent a prospect of direct clinical benefit, institutional review board
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b466b7377658b647bc811f4f0b252f6a
https://doi.org/10.1093/med-psych/9780190647254.003.0006
https://doi.org/10.1093/med-psych/9780190647254.003.0006
Autor:
DONNA L. SNYDER
Publikováno v:
The American Journal of Nursing. 88:806
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9cd574ac2dbbfe67075f83b28b7eb04d
https://doi.org/10.2307/3425792
https://doi.org/10.2307/3425792