212 related articles for article (PubMed ID: 27364807)
21. Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020.
Abulwerdi GA; Ramamoorthy A; Bashaw E; Burckart GJ; Madabushi R; Fletcher EP
Clin Transl Sci; 2023 Oct; 16(10):2046-2057. PubMed ID: 37551830
[TBL] [Abstract][Full Text] [Related]
22. Unapproved prescription cough, cold, and allergy drug products: recent US Food and Drug Administration regulatory action on unapproved cough, cold, and allergy medications.
Ostroff C; Lee CE; McMeekin J
Chest; 2011 Aug; 140(2):295-300. PubMed ID: 21813527
[TBL] [Abstract][Full Text] [Related]
23. 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]
24. Drug Repurposing for Ebola Virus Disease: Principles of Consideration and the Animal Rule.
Bai JPF; Hsu CW
J Pharm Sci; 2019 Feb; 108(2):798-806. PubMed ID: 30244014
[TBL] [Abstract][Full Text] [Related]
25. Lost in translation: differences in antimicrobial indication approval policies between the United States and Europe.
Pappas G; Ierodiakonou V; Falagas ME
Clin Ther; 2009 Jul; 31(7):1595-603. PubMed ID: 19695409
[TBL] [Abstract][Full Text] [Related]
26. Exposure-Response of Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients.
Wang J; Mehrotra N; Kim I; Lee SC; Sohrabi F; He R; Mulberg A; Sinha V; Ahn HY; Bashaw D; Griebel D
J Pediatr Gastroenterol Nutr; 2016 Oct; 63(4):412-6. PubMed ID: 26913757
[TBL] [Abstract][Full Text] [Related]
27. Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009.
Outterson K; Powers JH; Seoane-Vazquez E; Rodriguez-Monguio R; Kesselheim AS
J Law Med Ethics; 2013; 41(3):688-96. PubMed ID: 24088160
[TBL] [Abstract][Full Text] [Related]
28. Timing of Pediatric Drug Approval and Clinical Evidence Submitted to Regulatory Authorities: International Comparison Among Japan, the United States, and the European Union.
Hirota S; Yamaguchi T
Clin Pharmacol Ther; 2020 Nov; 108(5):985-994. PubMed ID: 31869436
[TBL] [Abstract][Full Text] [Related]
29. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.
Davit BM; Nwakama PE; Buehler GJ; Conner DP; Haidar SH; Patel DT; Yang Y; Yu LX; Woodcock J
Ann Pharmacother; 2009 Oct; 43(10):1583-97. PubMed ID: 19776300
[TBL] [Abstract][Full Text] [Related]
30. The Tropical Disease Priority Review Voucher: A Game-Changer for Tropical Disease Products.
Berman J; Radhakrishna T
Am J Trop Med Hyg; 2017 Jan; 96(1):11-13. PubMed ID: 27573627
[TBL] [Abstract][Full Text] [Related]
31. A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration.
Liu XI; Schuette P; Burckart GJ; Green DJ; La J; Burnham JM; Rakhmanina N; Robb A; Huang SM; van den Anker JN
J Pediatr; 2019 May; 208():236-242.e3. PubMed ID: 30679050
[TBL] [Abstract][Full Text] [Related]
32. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.
Xu K; Coté TR
Brief Bioinform; 2011 Jul; 12(4):341-5. PubMed ID: 21357612
[TBL] [Abstract][Full Text] [Related]
33. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.
Kesselheim AS; Polinski JM; Fulchino LA; Isaman DL; Gagne JJ
Drugs; 2015 Apr; 75(6):633-50. PubMed ID: 25822610
[TBL] [Abstract][Full Text] [Related]
34. Effects of the pharmaceutical technologic aspects of oral pediatric drugs on patient-related outcomes: a systematic literature review.
van Riet-Nales DA; Schobben AF; Egberts TC; Rademaker CM
Clin Ther; 2010 May; 32(5):924-38. PubMed ID: 20685501
[TBL] [Abstract][Full Text] [Related]
35. Priorities for the Priority Review Voucher.
Ridley DB
Am J Trop Med Hyg; 2017 Jan; 96(1):14-15. PubMed ID: 27573624
[TBL] [Abstract][Full Text] [Related]
36. Linezolid pharmacokinetics in pediatric patients: an overview.
Jungbluth GL; Welshman IR; Hopkins NK
Pediatr Infect Dis J; 2003 Sep; 22(9 Suppl):S153-7. PubMed ID: 14520140
[TBL] [Abstract][Full Text] [Related]
37. Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration.
Liu XI; Dallmann A; Wang YM; Green DJ; Burnham JM; Chiang B; Wu P; Sheng M; Lu K; van den Anker JN; Burckart GJ
J Clin Pharmacol; 2019 Aug; 59(8):1130-1143. PubMed ID: 30865317
[TBL] [Abstract][Full Text] [Related]
38. 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]
39. Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.
Mehrotra N; Bhattaram A; Earp JC; Florian J; Krudys K; Lee JE; Lee JY; Liu J; Mulugeta Y; Yu J; Zhao P; Sinha V
Drug Metab Dispos; 2016 Jul; 44(7):924-33. PubMed ID: 27079249
[TBL] [Abstract][Full Text] [Related]
40. Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
Green DJ; Sun H; Burnham J; Liu XI; van den Anker J; Temeck J; Yao L; McCune SK; Burckart GJ
Clin Pharmacol Ther; 2019 Mar; 105(3):555-557. PubMed ID: 30094815
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
