212 related articles for article (PubMed ID: 27364807)
1. Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval.
Zimmerman K; Putera M; Hornik CP; Brian Smith P; Benjamin DK; Mulugeta Y; Burckart GJ; Cohen-Wolkowiez M; Gonzalez D
Clin Ther; 2016 Sep; 38(9):1995-2005. PubMed ID: 27364807
[TBL] [Abstract][Full Text] [Related]
2. Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.
Mulugeta Y; Barrett JS; Nelson R; Eshete AT; Mushtaq A; Yao L; Glasgow N; Mulberg AE; Gonzalez D; Green D; Florian J; Krudys K; Seo S; Kim I; Chilukuri D; Burckart GJ
J Clin Pharmacol; 2016 Nov; 56(11):1326-1334. PubMed ID: 27040726
[TBL] [Abstract][Full Text] [Related]
3. Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response.
Earp JC; Mehrotra N; Peters KE; Fiorentino RP; Griebel D; Lee SC; Mulberg A; Röhss K; Sandström M; Taylor A; Tornøe CW; Wynn EL; Van der Walt JS; Garnett C
J Pediatr Gastroenterol Nutr; 2017 Sep; 65(3):272-277. PubMed ID: 27875488
[TBL] [Abstract][Full Text] [Related]
4. Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.
Zimmerman KO; Smith PB; McMahon AW; Temeck J; Avant D; Murphy D; McCune S
JAMA Pediatr; 2019 Jan; 173(1):60-67. PubMed ID: 30452504
[TBL] [Abstract][Full Text] [Related]
5. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
DiMasi JA
Clin Ther; 2013 Jun; 35(6):808-18. PubMed ID: 23726388
[TBL] [Abstract][Full Text] [Related]
6. Pediatric drug information available at the time of new drug approvals: A cross-sectional analysis.
Hudgins JD; Bacho MA; Olsen KL; Bourgeois FT
Pharmacoepidemiol Drug Saf; 2018 Feb; 27(2):161-167. PubMed ID: 29148107
[TBL] [Abstract][Full Text] [Related]
7. Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis.
Wang B; Franklin JM; Eddings W; Landon J; Kesselheim AS
PLoS One; 2016; 11(3):e0152195. PubMed ID: 27032095
[TBL] [Abstract][Full Text] [Related]
8. Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review.
Goring S; Taylor A; Müller K; Li TJJ; Korol EE; Levy AR; Freemantle N
BMJ Open; 2019 Feb; 9(2):e024895. PubMed ID: 30819708
[TBL] [Abstract][Full Text] [Related]
9. US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.
Hey SP; Kesselheim AS; Patel P; Mehrotra P; Powers JH
JAMA Intern Med; 2020 Jan; 180(1):131-138. PubMed ID: 31710344
[TBL] [Abstract][Full Text] [Related]
10. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Ceci A; Felisi M; Catapano M; Baiardi P; Cipollina L; Ravera S; Bagnulo S; Reggio S; Rondini G
Eur J Clin Pharmacol; 2002 Nov; 58(8):495-500. PubMed ID: 12451425
[TBL] [Abstract][Full Text] [Related]
11. Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.
Tanaudommongkon I; John Miyagi S; Green DJ; Burnham JM; van den Anker JN; Park K; Wu J; McCune SK; Yao L; Burckart GJ
Clin Pharmacol Ther; 2020 Nov; 108(5):1018-1025. PubMed ID: 32394430
[TBL] [Abstract][Full Text] [Related]
12. 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]
13. Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives.
Hirschfeld S; Ho PT; Smith M; Pazdur R
J Clin Oncol; 2003 Mar; 21(6):1066-73. PubMed ID: 12637472
[TBL] [Abstract][Full Text] [Related]
14. Exposure-Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration.
Zhang Y; Wang Y; Khurana M; Sachs HC; Zhu H; Burckart GJ; Alexander J; Yao LP; Wang J
Clin Pharmacol Ther; 2020 Jul; 108(1):90-98. PubMed ID: 32030741
[TBL] [Abstract][Full Text] [Related]
15. In Vitro-to-In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018.
Yu J; Ragueneau-Majlessi I
Clin Transl Sci; 2020 Jul; 13(4):693-699. PubMed ID: 31981398
[TBL] [Abstract][Full Text] [Related]
16. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.
Sacks LV; Shamsuddin HH; Yasinskaya YI; Bouri K; Lanthier ML; Sherman RE
JAMA; 2014 Jan 22-29; 311(4):378-84. PubMed ID: 24449316
[TBL] [Abstract][Full Text] [Related]
17. 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]
18. 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]
19. Food and Drug Administration approval process for ophthalmic drugs in the US.
Lloyd R; Harris J; Wadhwa S; Chambers W
Curr Opin Ophthalmol; 2008 May; 19(3):190-4. PubMed ID: 18408492
[TBL] [Abstract][Full Text] [Related]
20. Food-Drug Effects and Pediatric Drug Development Studies Submitted to the US Food and Drug Administration, 2012-2022.
Tunehag KR; George B; Samuels S; Vo K; Arya V; Abulwerdi G; Burckart GJ
J Clin Pharmacol; 2024 Jun; 64(6):697-703. PubMed ID: 38294346
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]