2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil-Reference-Cited by-同舟云学术

2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil

Published:2017-07 Issue:7 Volume:10 Page:
ISSN:1941-7713
Container-title:Circulation: Cardiovascular Quality and Outcomes
language:en
Short-container-title:Circ: Cardiovascular Quality and Outcomes

Author:

Sable Craig A.¹,Ivy D. Dunbar¹,Beekman Robert H.¹,Clayton-Jeter Helene D.¹,Jenkins Kathy J.¹,Mahle William T.¹,Morrow William R.¹,Murphy Mary Dianne¹,Nelson Robert M.¹,Rosenthal Geoffrey L.¹,Stockbridge Norman¹,Wessel David L.¹

Affiliation:

1. American College of Cardiology Representative. US Food and Drug Administration Representative. American Academy of Pediatrics Representative. US Food and Drug Administration Representative. Retired from the US Food and Drug Administration during the development of this statement.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

Link

https://www.ahajournals.org/doi/pdf/10.1161/HCQ.0000000000000026

Reference31 articles.

1. Pediatric Cardiovascular Drug Trials, Lessons Learned

2. Pediatric Information in Drug Product Labeling

3. Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health

4. Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature

5. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety

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