These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
2. 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]
3. Influence of kidney disease on drug disposition: An assessment of industry studies submitted to the FDA for new chemical entities 1999-2010. Matzke GR; Dowling TC; Marks SA; Murphy JE J Clin Pharmacol; 2016 Apr; 56(4):390-8. PubMed ID: 26238947 [TBL] [Abstract][Full Text] [Related]
4. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Willke RJ; Burke LB; Erickson P Control Clin Trials; 2004 Dec; 25(6):535-52. PubMed ID: 15588741 [TBL] [Abstract][Full Text] [Related]
5. Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease. Zhang L; Xu N; Xiao S; Arya V; Zhao P; Lesko LJ; Huang SM J Clin Pharmacol; 2012 Jan; 52(1 Suppl):79S-90S. PubMed ID: 22232757 [TBL] [Abstract][Full Text] [Related]
6. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999. Cross J; Lee H; Westelinck A; Nelson J; Grudzinskas C; Peck C Pharmacoepidemiol Drug Saf; 2002 Sep; 11(6):439-46. PubMed ID: 12426927 [TBL] [Abstract][Full Text] [Related]
7. Strength of evidence for labeled dosing recommendations in renal impairment. Gagne JJ; Khan NF; Raj TS; Patel LR; Choudhry NK Clin Trials; 2017 Apr; 14(2):219-221. PubMed ID: 27780884 [TBL] [Abstract][Full Text] [Related]
8. Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Zhang Y; Zhang L; Abraham S; Apparaju S; Wu TC; Strong JM; Xiao S; Atkinson AJ; Thummel KE; Leeder JS; Lee C; Burckart GJ; Lesko LJ; Huang SM Clin Pharmacol Ther; 2009 Mar; 85(3):305-11. PubMed ID: 19020495 [TBL] [Abstract][Full Text] [Related]
9. Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Huang SM; Temple R; Throckmorton DC; Lesko LJ Clin Pharmacol Ther; 2007 Feb; 81(2):298-304. PubMed ID: 17259955 [TBL] [Abstract][Full Text] [Related]
10. A review of patient-reported outcome labels in the United States: 2006 to 2010. Gnanasakthy A; Mordin M; Clark M; DeMuro C; Fehnel S; Copley-Merriman C Value Health; 2012 May; 15(3):437-42. PubMed ID: 22583453 [TBL] [Abstract][Full Text] [Related]
11. 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]
12. Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use. Frueh FW; Amur S; Mummaneni P; Epstein RS; Aubert RE; DeLuca TM; Verbrugge RR; Burckart GJ; Lesko LJ Pharmacotherapy; 2008 Aug; 28(8):992-8. PubMed ID: 18657016 [TBL] [Abstract][Full Text] [Related]
13. Analysis of US Food and Drug Administration Oncology Approvals on the Characterization of Hepatic Impairment Effect and Dosing Recommendations. Yang DZ; Alhadab A; Parivar K; Wang DD; Elmeliegy M Clin Pharmacol Ther; 2022 Oct; 112(4):782-790. PubMed ID: 34870845 [TBL] [Abstract][Full Text] [Related]
14. 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]
15. Discordance Between Child-Pugh and National Cancer Institute Classifications for Hepatic Dysfunction: Implications on Dosing Recommendations for Oncology Compounds. Elmeliegy M; Yang DZ; Salama E; Parivar K; Wang DD J Clin Pharmacol; 2021 Jan; 61(1):105-115. PubMed ID: 32691438 [TBL] [Abstract][Full Text] [Related]
16. Renal drug dosing recommendations: evaluation of product information for brands of the same drug. Khanal A; Peterson GM; Castelino RL; Jose MD Intern Med J; 2014 Jun; 44(6):591-6. PubMed ID: 24946814 [TBL] [Abstract][Full Text] [Related]
17. The major role of clinicians in the discovery of off-label drug therapies. Demonaco HJ; Ali A; Hippel Ev Pharmacotherapy; 2006 Mar; 26(3):323-32. PubMed ID: 16503712 [TBL] [Abstract][Full Text] [Related]
18. Are hepatic impairment studies necessary for therapeutic proteins? Yang J; Shord S; Zhao H; Men Y; Rahman A Clin Ther; 2013 Sep; 35(9):1444-51. PubMed ID: 23891362 [TBL] [Abstract][Full Text] [Related]
19. What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling. Willy ME; Li Z Pharmacoepidemiol Drug Saf; 2004 Apr; 13(4):201-6. PubMed ID: 15255086 [TBL] [Abstract][Full Text] [Related]
20. Applications of population pharmacokinetics in current drug labelling. Duan JZ J Clin Pharm Ther; 2007 Feb; 32(1):57-79. PubMed ID: 17286790 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]