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2002 2
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The Best Pharmaceuticals for Children Act and Pediatric Research Equity Act reach the age of majority-An oncology perspective.
Bernhardt MB, Lindsay H, Allen-Rhoades W, Foster JH. Bernhardt MB, et al. Pediatr Blood Cancer. 2021 Mar;68(3):e28871. doi: 10.1002/pbc.28871. Epub 2020 Dec 31. Pediatr Blood Cancer. 2021. PMID: 33381908
The ontogeny of infants, children, and adolescents over the course of the first two decades of life pose complex pharmacokinetic, dosing, administration, effectiveness, and toxicity-related questions that require specific investigation. Here, we review the history that led to the …
The ontogeny of infants, children, and adolescents over the course of the first two decades of life pose complex pharmacokinetic, dosing, ad …
Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.
Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Board on Health Sciences Policy; Institute of Medicine; Field MJ, Boat TF, editors. Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), et al. Washington (DC): National Academies Press (US); 2012 Feb 29. Washington (DC): National Academies Press (US); 2012 Feb 29. PMID: 24872968 Free Books & Documents. Review.
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. ...
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity
Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?
Ren Z, Zajicek A. Ren Z, et al. Semin Perinatol. 2015 Nov;39(7):530-1. doi: 10.1053/j.semperi.2015.08.006. Epub 2015 Oct 9. Semin Perinatol. 2015. PMID: 26455383 Free PMC article. Review.
Children have been called therapeutic orphans as they have been excluded from drug research and new drug development resulting in the lack of proper labels for majority of the drugs for pediatric use. The Best Pharmaceuticals for Children Act (B …
Children have been called therapeutic orphans as they have been excluded from drug research and new drug development resulting in the lack o …
Racial and Ethnic Diversity in Studies Funded Under the Best Pharmaceuticals for Children Act.
Abdel-Rahman SM, Paul IM, Hornik C, Sullivan JE, Wade K, Delmore P, Sharma G, Benjamin DK, Zimmerman KO. Abdel-Rahman SM, et al. Pediatrics. 2021 May;147(5):e2020042903. doi: 10.1542/peds.2020-042903. Epub 2021 Apr 12. Pediatrics. 2021. PMID: 33846237 Free PMC article.
BACKGROUND AND OBJECTIVES: The Best Pharmaceuticals for Children Act (BPCA) incentivizes the study of on-patent medicines in children and mandates that the National Institutes of Health sponsor research on off-patent drugs important to pediatric …
BACKGROUND AND OBJECTIVES: The Best Pharmaceuticals for Children Act (BPCA) incentivizes the study of on- …
Dermatology Drugs for Children-U.S. Food and Drug Administration Perspective.
Epps RE. Epps RE. Dermatol Clin. 2022 Jul;40(3):289-296. doi: 10.1016/j.det.2022.02.004. Epub 2022 Jun 1. Dermatol Clin. 2022. PMID: 35750412 Review.
Drug development regulation needs of the pediatric population were not addressed until later in the twentieth century. Because of legislation including the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equi
Drug development regulation needs of the pediatric population were not addressed until later in the twentieth century. Because of legislatio …
FDA update.
Katz R. Katz R. Epilepsy Res. 2006 Jan;68(1):85-94. doi: 10.1016/j.eplepsyres.2005.09.034. Epilepsy Res. 2006. PMID: 16377143 Review.
The FDA has requested that sponsors search their databases for selected problems under review (e.g., suicidality). PEDIATRICS: The Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BP …
The FDA has requested that sponsors search their databases for selected problems under review (e.g., suicidality). PEDIATRICS: The Pediat
Beyond the Guidelines: A Narrative Review of Treatments on the Horizon for Migraine in Children and Adolescents.
VanderPluym JH, Victorio MCC, Oakley CB, Rastogi RG, Orr SL. VanderPluym JH, et al. Neurology. 2023 Oct 31;101(18):788-797. doi: 10.1212/WNL.0000000000207677. Epub 2023 Aug 21. Neurology. 2023. PMID: 37604658 Review.
There are relatively limited evidence-based treatment options available, especially when compared with treatment of migraine in adults. The Pediatric Research Equity Act requires the study of a new drug or biologic in pediatric populations. ...
There are relatively limited evidence-based treatment options available, especially when compared with treatment of migraine in adults. The …
Summary of the National Institute of Child Health and Human Development-best pharmaceuticals for Children Act Pediatric Formulation Initiatives Workshop-Pediatric Biopharmaceutics Classification System Working Group.
Abdel-Rahman SM, Amidon GL, Kaul A, Lukacova V, Vinks AA, Knipp GT; Members of the BCS Task Force. Abdel-Rahman SM, et al. Clin Ther. 2012 Nov;34(11):S11-24. doi: 10.1016/j.clinthera.2012.09.014. Clin Ther. 2012. PMID: 23149009 Free PMC article. Review.
Formulation Challenges and Strategies to Develop Pediatric Dosage Forms.
Malkawi WA, AlRafayah E, AlHazabreh M, AbuLaila S, Al-Ghananeem AM. Malkawi WA, et al. Children (Basel). 2022 Apr 1;9(4):488. doi: 10.3390/children9040488. Children (Basel). 2022. PMID: 35455532 Free PMC article. Review.
The use of adult drugs to treat children is a legislation concern, as it may result in incorrect dose, safety, and efficacy. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA …
The use of adult drugs to treat children is a legislation concern, as it may result in incorrect dose, safety, and efficacy. The Best
175 results