Pharmacokinetic analysis of 14C-ursodiol in newborn infants using accelerator mass spectrometry

Journal of Clinical Pharmacology

Volumn 54, Issue 9, 2014, Pages 1031-1037

  Gordi, Toufigh ^a   Baillie, Rebecca ^a   Vuong, Le T ^b   Abidi, Saira ^b   Dueker, Stephen ^b   Vasquez, Herbert ^c   Pegis, Priscilla ^c   Hopper, Andrew O ^c   Power, Gordon G ^c   Blood, Arlin B ^c  

^a Rosa and Co LLC   (United States)

^b Eckert and Ziegler Vitalea Science   (United States)

^c LOMA LINDA UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

accelerator mass spectrometry; bile acid; infants; microdosing; pediatrics; pharmacokinetics; ursodiol

Indexed keywords

BILIRUBIN GLUCURONIDE; RADIOPHARMACEUTICAL AGENT; UNCLASSIFIED DRUG; URSODEOXYCHOLIC ACID; URSODIOL CARBON 14; CARBON; TRACER;

ACCELERATOR MASS SPECTROMETRY; ARTICLE; BILIRUBIN BLOOD LEVEL; CHOLESTASIS; CLINICAL ARTICLE; COMPARTMENT MODEL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG MICRODOSE; DRUG SAFETY; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; MASS SPECTROMETRY; NEWBORN; PILOT STUDY; PLASMA CONCENTRATION-TIME CURVE; SINGLE DRUG DOSE; BIOLOGICAL MODEL; BLOOD; CLINICAL TRIAL; INFANT; METABOLISM; PHASE 1 CLINICAL TRIAL; PROCEDURES;

CARBON RADIOISOTOPES; CHOLESTASIS; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; MALE; MASS SPECTROMETRY; MODELS, BIOLOGICAL; RADIOACTIVE TRACERS; URSODEOXYCHOLIC ACID;

EID: 84905570997     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.327     Document Type: Article

References (26)

1. Vuong LT, Blood AB, Vogel JS, Anderson ME, Goldstein B,. Applications of accelerator MS in pediatric drug evaluation. Bioanalysis. 2012; 4 (15): 1871-1882.
2. Conroy S, McIntyre J,. The use of unlicensed and off-label medicines in the neonate. Semin Fetal Neonatal Med. 2005; 10 (2): 115-122.
3. Le Vuong T, Buchholz BA, Lame MW, Dueker SR,. Phytochemical research using accelerator mass spectrometry. Nutr Rev. 2004; 62 (10): 375-388.
4. Rowland M,. Microdosing: a critical assessment of human data. J Pharm Sci. 2012; 101 (11): 4067-4074.
5. Lappin G, Garner RC,. Current perspectives of 14C-isotope measurement in biomedical accelerator mass spectrometry. Anal Bioanal Chem. 2004; 378 (2): 356-364.
6. Stenstrom K, Leide-Svegborn S, Erlandsson B, et al. Application of accelerator mass spectrometry (AMS) for high-sensitivity measurements of 14CO2 in long-term studies of fat metabolism. Appl Radiat Isot. 1996; 47 (4): 417-422.
7. Colombo C, Roda A, Roda E, et al. Evaluation of an oral ursodeoxycholic acid load in the assessment of bile acid malabsorption in cystic fibrosis. Dig Dis Sci. 1983; 28 (4): 306-311.
8. Setchell KD, Galzigna L, O'Connell N, Brunetti G, Tauschel HD,. Bioequivalence of a new liquid formulation of ursodeoxycholic acid (Ursofalk suspension) and Ursofalk capsules measured by plasma pharmacokinetics and biliary enrichment. Aliment Pharmacol Ther. 2005; 21 (6): 709-721.
9. Moyer V, Freese DK, Whitington PF, et al. Guideline for the evaluation of cholestatic jaundice in infants: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2004; 39 (2): 115-128.
10. Dick MC, Mowat AP,. Hepatitis syndrome in infancy-an epidemiological survey with 10 year follow up. Arch Dis Child. 1985; 60 (6): 512-516.
11. McKiernan PJ,. Neonatal cholestasis. Semin Neonatol. 2002; 7 (2): 153-165.
12. Champion V, Carbajal R, Lozar J, Girard I, Mitanchez D,. Risk factors for developing transient neonatal cholestasis. J Pediatr Gastroenterol Nutr. 2012; 55 (5): 592-598.
13. Ishizaki K, Imada T, Tsurufuji M,. Hepatoprotective bile acid 'ursodeoxycholic acid (UDCA)' property and difference as bile acids. Hepatol Res. 2005; 33 (2): 174-177.
14. Levine A, Maayan A, Shamir R, Dinari G, Sulkes J, Sirotta L,. Parenteral nutrition-associated cholestasis in preterm neonates: evaluation of ursodeoxycholic acid treatment. J Pediatr Endocrinol Metab. 1999; 12 (4): 549-553.
15. Balistreri WF,. Bile acid therapy in pediatric hepatobiliary disease: the role of ursodeoxycholic acid. J Pediatr Gastroenterol Nutr. 1997; 24 (5): 573-589.
16. Spagnuolo MI, Iorio R, Vegnente A, Guarino A,. Ursodeoxycholic acid for treatment of cholestasis in children on long-term total parenteral nutrition: a pilot study. Gastroenterology. 1996; 111 (3): 716-719.
17. De Marco G, Sordino D, Bruzzese E, et al. Early treatment with ursodeoxycholic acid for cholestasis in children on parenteral nutrition because of primary intestinal failure. Aliment Pharmacol Ther. 2006; 24 (2): 387-394.
18. Rubin RA, Kowalski TE, Khandelwal M, Malet PF,. Ursodiol for hepatobiliary disorders. Ann Intern Med. 1994; 121 (3): 207-218.
19. Kubota K, Yamaoka K, Ishizaki T, et al. A pharmacokinetic analysis of enterohepatic circulation of ursodeoxycholic acid, a drug with a high hepatic extraction but a small clearance. Res Commun Chem Pathol Pharmacol. 1988; 62 (2): 309-326.
20. Ognibene TJ, Bench G, Vogel JS, Peaslee GF, Murov S,. A high-throughput method for the conversion of CO2 obtained from biochemical samples to graphite in septa-sealed vials for quantification of 14C via accelerator mass spectrometry. Anal Chem. 2003; 75 (9): 2192-2196.
21. Schulze-König T, Dueker SR, Giacomo J, Suter M, Vogel JS, Synal H-A,. BioMICADAS: compact next generation AMS system for pharmaceutical science. Nucl Instrum Methods Phys Res B. 2010; 268 (7-8): 891-894.
22. Beal S, Sheiner LB, Boeckmann A, Bauer RJ, eds,. NONMEM User's Guides (1989-2009). Ellicott City, MD, USA: Icon Development Solutions; 2009.
23. Jonsson EN, Karlsson MO,. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed. 1999; 58 (1): 51-64.
24. Grajewski B, Waters MA, Yong LC, Tseng CY, Zivkovich Z, Cassinelli RT, II,. Airline pilot cosmic radiation and circadian disruption exposure assessment from logbooks and company records. Ann Occup Hyg. 2011; 55 (5): 465-475.
25. Nagano K, Kusaka T, Okubo K, et al. Estimation of circulating blood volume in infants using the pulse dye densitometry method. Paediatr Anaesth. 2005; 15 (2): 125-130.
26. Davis JM, Connor EM, Wood AJ,. The need for rigorous evidence on medication use in preterm infants: is it time for a neonatal rule? JAMA. 2012; 308 (14): 1435-1436.