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Items: 16

1.

Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives.

Marshall S, Madabushi R, Manolis E, Krudys K, Staab A, Dykstra K, Visser SAG.

CPT Pharmacometrics Syst Pharmacol. 2019 Feb;8(2):87-96. doi: 10.1002/psp4.12372. Epub 2019 Feb 1.

2.

Modeling and simulation in dose determination for biodefense products approved under the FDA animal rule.

Bergman KL, Krudys K, Seo SK, Florian J.

J Pharmacokinet Pharmacodyn. 2017 Apr;44(2):153-160. doi: 10.1007/s10928-017-9516-2. Epub 2017 Mar 15.

PMID:
28299529
3.

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. doi: 10.1124/dmd.116.069559. Epub 2016 Apr 14. Review.

PMID:
27079249
4.

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. doi: 10.1002/jcph.744. Review.

5.

Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase.

Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green CL, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz RR, Zhou M, Stockbridge N.

Clin Pharmacol Ther. 2015 Apr;97(4):326-35. doi: 10.1002/cpt.60.

PMID:
25670536
6.

The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".

Darpo B, Sarapa N, Garnett C, Benson C, Dota C, Ferber G, Jarugula V, Johannesen L, Keirns J, Krudys K, Ortemann-Renon C, Riley S, Rogers-Subramaniam D, Stockbridge N.

Ann Noninvasive Electrocardiol. 2014 Jan;19(1):70-81. doi: 10.1111/anec.12128. Epub 2013 Dec 30. Review.

PMID:
24372708
7.

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. doi: 10.1001/jamapediatrics.2013.465.

PMID:
23921678
8.

Knowledge management for efficient quantitative analyses during regulatory reviews.

Krudys K, Li F, Florian J, Tornoe C, Chen Y, Bhattaram A, Jadhav P, Neal L, Wang Y, Gobburu J, Lee PI.

Expert Rev Clin Pharmacol. 2011 Nov;4(6):697-703. doi: 10.1586/ecp.11.56. Review.

PMID:
22111855
9.

Assessing the probability of drug-induced QTc-interval prolongation during clinical drug development.

Chain AS, Krudys KM, Danhof M, Della Pasqua O.

Clin Pharmacol Ther. 2011 Dec;90(6):867-75. doi: 10.1038/clpt.2011.202. Epub 2011 Nov 2.

PMID:
22048226
10.

Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.

Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, Jadhav PR, Krudys K, Lesko LJ, Li F, Liu J, Madabushi R, Marathe A, Mehrotra N, Tornoe C, Wang Y, Zhu H.

Clin Pharmacokinet. 2011 Oct;50(10):627-35. doi: 10.2165/11593210-000000000-00000.

PMID:
21895036
11.

Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice.

Hebert MF, Ma X, Naraharisetti SB, Krudys KM, Umans JG, Hankins GD, Caritis SN, Miodovnik M, Mattison DR, Unadkat JD, Kelly EJ, Blough D, Cobelli C, Ahmed MS, Snodgrass WR, Carr DB, Easterling TR, Vicini P; Obstetric-Fetal Pharmacology Research Unit Network.

Clin Pharmacol Ther. 2009 Jun;85(6):607-14. doi: 10.1038/clpt.2009.5. Epub 2009 Mar 18.

12.

Efficacy of pulmonary insulin delivery in diabetic rats: use of a model-based approach in the evaluation of insulin powder formulations.

Amidi M, Krudys KM, Snel CJ, Crommelin DJ, Della Pasqua OE, Hennink WE, Jiskoot W.

J Control Release. 2008 May 8;127(3):257-66. doi: 10.1016/j.jconrel.2008.01.019. Epub 2008 Feb 12.

PMID:
18353483
13.

Use of oral glucose minimal model-derived index of insulin sensitivity in subjects with early type 1 diabetes mellitus.

Krudys KM, Greenbaum CJ, Pihoker C, Vicini P.

Metabolism. 2008 Apr;57(4):445-7. doi: 10.1016/j.metabol.2007.10.001.

PMID:
18328342
14.
15.

Paradoxical role of cytochrome P450 3A in the bioactivation and clinical effects of levo-alpha-acetylmethadol: importance of clinical investigations to validate in vitro drug metabolism studies.

Kharasch ED, Whittington D, Hoffer C, Krudys K, Craig K, Vicini P, Sheffels P, Lalovic B.

Clin Pharmacokinet. 2005;44(7):731-51.

PMID:
15966756
16.

Integrated model of hepatic and peripheral glucose regulation for estimation of endogenous glucose production during the hot IVGTT.

Krudys KM, Dodds MG, Nissen SM, Vicini P.

Am J Physiol Endocrinol Metab. 2005 May;288(5):E1038-46. Epub 2005 Jan 4.

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