383 related articles for article (PubMed ID: 23921678)
1. Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007.
Momper JD; Mulugeta Y; Green DJ; Karesh A; Krudys KM; Sachs HC; Yao LP; Burckart GJ
JAMA Pediatr; 2013 Oct; 167(10):926-32. PubMed ID: 23921678
[TBL] [Abstract][Full Text] [Related]
2. Improving pediatric dosing through pediatric initiatives: what we have learned.
Rodriguez W; Selen A; Avant D; Chaurasia C; Crescenzi T; Gieser G; Di Giacinto J; Huang SM; Lee P; Mathis L; Murphy D; Murphy S; Roberts R; Sachs HC; Suarez S; Tandon V; Uppoor RS
Pediatrics; 2008 Mar; 121(3):530-9. PubMed ID: 18310202
[TBL] [Abstract][Full Text] [Related]
3. Prescribing medications in pediatrics: concerns regarding FDA approval and pharmacokinetics.
Novak E; Allen PJ
Pediatr Nurs; 2007; 33(1):64-70. PubMed ID: 17411005
[TBL] [Abstract][Full Text] [Related]
4. The integration of allometry and virtual populations to predict clearance and clearance variability in pediatric populations over the age of 6 years.
Edginton AN; Shah B; Sevestre M; Momper JD
Clin Pharmacokinet; 2013 Aug; 52(8):693-703. PubMed ID: 23588537
[TBL] [Abstract][Full Text] [Related]
5. Pediatric exclusivity: evolving legislation and novel complexities within pediatric therapeutic development.
Rivera DR; Hartzema AG
Ann Pharmacother; 2014 Mar; 48(3):369-79. PubMed ID: 24311725
[TBL] [Abstract][Full Text] [Related]
6. Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels.
Chang Y; Burckart GJ; Lesko LJ; Dowling TC
J Clin Pharmacol; 2013 Sep; 53(9):962-6. PubMed ID: 23832278
[TBL] [Abstract][Full Text] [Related]
7. Allometry Is a Reasonable Choice in Pediatric Drug Development.
Liu T; Ghafoori P; Gobburu JV
J Clin Pharmacol; 2017 Apr; 57(4):469-475. PubMed ID: 27649629
[TBL] [Abstract][Full Text] [Related]
8. Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.
Hwang TJ; Orenstein L; Kesselheim AS; Bourgeois FT
JAMA Pediatr; 2019 Jan; 173(1):68-74. PubMed ID: 30452498
[TBL] [Abstract][Full Text] [Related]
9. Regulatory issues in pediatric psychopharmacology.
Laughren TP
J Am Acad Child Adolesc Psychiatry; 1996 Oct; 35(10):1276-82. PubMed ID: 8885581
[TBL] [Abstract][Full Text] [Related]
10. A systematic comparison of cockcroft-gault and modification of diet in renal disease equations for classification of kidney dysfunction and dosage adjustment.
Park EJ; Wu K; Mi Z; Dong T; Lawrence JP; Ko CW; Huang SM; Zhang L; Crentsil V; Zhang J; Xu NN
Ann Pharmacother; 2012 Sep; 46(9):1174-87. PubMed ID: 22932303
[TBL] [Abstract][Full Text] [Related]
11. IOM Review of FDA--approved biologics labeled or studied for pediatric use.
Field MJ; Ellinger LK; Boat TF
Pediatrics; 2013 Feb; 131(2):328-35. PubMed ID: 23319521
[TBL] [Abstract][Full Text] [Related]
12. Drug dosing based on weight and body surface area: mathematical assumptions and limitations in obese adults.
Pai MP
Pharmacotherapy; 2012 Sep; 32(9):856-68. PubMed ID: 22711238
[TBL] [Abstract][Full Text] [Related]
13. Comparative evaluation of US Food and Drug Administration and pharmacologically guided approaches to determine the maximum recommended starting dose for first-in-human clinical trials in adult healthy men.
Imam MT; Venkateshan SP; Tandon M; Saha N; Pillai KK
J Clin Pharmacol; 2011 Dec; 51(12):1655-64. PubMed ID: 21415286
[TBL] [Abstract][Full Text] [Related]
14. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies.
Roberts R; Rodriguez W; Murphy D; Crescenzi T
JAMA; 2003 Aug; 290(7):905-11. PubMed ID: 12928467
[TBL] [Abstract][Full Text] [Related]
15. Extrapolation of adult data and other data in pediatric drug-development programs.
Dunne J; Rodriguez WJ; Murphy MD; Beasley BN; Burckart GJ; Filie JD; Lewis LL; Sachs HC; Sheridan PH; Starke P; Yao LP
Pediatrics; 2011 Nov; 128(5):e1242-9. PubMed ID: 22025597
[TBL] [Abstract][Full Text] [Related]
16. Obesity and Pediatric Drug Development.
Vaughns JD; Conklin LS; Long Y; Zheng P; Faruque F; Green DJ; van den Anker JN; Burckart GJ
J Clin Pharmacol; 2018 May; 58(5):650-661. PubMed ID: 29350758
[TBL] [Abstract][Full Text] [Related]
17. The history and contemporary challenges of the US Food and Drug Administration.
Borchers AT; Hagie F; Keen CL; Gershwin ME
Clin Ther; 2007 Jan; 29(1):1-16. PubMed ID: 17379043
[TBL] [Abstract][Full Text] [Related]
18. Food and Drug Administration approval for medications used in the pediatric intensive care unit: a continuing conundrum.
Yang CP; Veltri MA; Anton B; Yaster M; Berkowitz ID
Pediatr Crit Care Med; 2011 Sep; 12(5):e195-9. PubMed ID: 21057369
[TBL] [Abstract][Full Text] [Related]
19. FDA Modernization Act: implications for oncology.
Morris L
Oncology (Williston Park); 1998 Nov; 12(11A):139-41. PubMed ID: 10028506
[TBL] [Abstract][Full Text] [Related]
20. Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2008 Aug; 73(164):49603-10. PubMed ID: 18958946
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
