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Journal Abstract Search
366 related items for PubMed ID: 24747236
1. Physiologically based pharmacokinetic modeling: from regulatory science to regulatory policy. Sinha V, Zhao P, Huang SM, Zineh I. Clin Pharmacol Ther; 2014 May; 95(5):478-80. PubMed ID: 24747236 [Abstract] [Full Text] [Related]
2. "Getting the dose right": facts, a blueprint, and encouragements. Peck CC, Cross JT. Clin Pharmacol Ther; 2007 Jul; 82(1):12-4. PubMed ID: 17571068 [No Abstract] [Full Text] [Related]
4. Microdosing Studies in Children: A US Regulatory Perspective. Roth-Cline M, Nelson RM. Clin Pharmacol Ther; 2015 Sep; 98(3):232-3. PubMed ID: 26095312 [Abstract] [Full Text] [Related]
5. Approaches to Japanese dose evaluation in global drug development: factors that generate different dosages between Japan and the United States. Nakashima K, Narukawa M, Takeuchi M. Clin Pharmacol Ther; 2011 Dec; 90(6):836-43. PubMed ID: 22048222 [Abstract] [Full Text] [Related]
6. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, Moon YJ, Song P, Brar SS, Madabushi R, Wu TC, Booth BP, Rahman NA, Reynolds KS, Gil Berglund E, Lesko LJ, Huang SM. Clin Pharmacol Ther; 2011 Feb; 89(2):259-67. PubMed ID: 21191381 [Abstract] [Full Text] [Related]
7. Why Collecting Pharmacokinetic Information After Intravenous Drug Administration Is Important. Hinderling PH, Papoian T. Clin Pharmacol Drug Dev; 2020 Feb; 9(2):146-150. PubMed ID: 31943891 [No Abstract] [Full Text] [Related]
8. Pharmacokinetic drug interaction studies must consider pharmacological heterogeneity, use of repeated dosing, and translation into a message understandable to practicing clinicians. de Leon J, Spina E, Diaz FJ. J Clin Psychopharmacol; 2009 Jun; 29(3):201-5. PubMed ID: 19440070 [No Abstract] [Full Text] [Related]
10. 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 [Abstract] [Full Text] [Related]
11. Sources of variability in clinical trials of new drugs for epilepsy. Leppik IE. Epilepsy Res Suppl; 1993 Oct; 10():157-66. PubMed ID: 8251091 [No Abstract] [Full Text] [Related]
15. Assessment of factors associated with dose differences between Japan and the United States. Arnold FL, Fukunaga S, Kusama M, Matsuki N, Ono S. Clin Pharmacol Ther; 2014 May; 95(5):542-9. PubMed ID: 24281222 [Abstract] [Full Text] [Related]
16. The use of the noninferiority analysis in clinical studies. Bermingham EC, del Castillo JR, Radecki SV. Equine Vet J; 2014 Jul; 46(4):399-401. PubMed ID: 24909652 [No Abstract] [Full Text] [Related]
19. Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006. Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JV, Jang SH, Kenna L, Lesko LJ, Madabushi R, Men Y, Powell JR, Qiu W, Ramchandani RP, Tornoe CW, Wang Y, Zheng JJ. Clin Pharmacol Ther; 2007 Feb; 81(2):213-21. PubMed ID: 17259946 [Abstract] [Full Text] [Related]