A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development

Clinical Pharmacology and Therapeutics

Volumn 98, Issue 3, 2015, Pages 328-335

  Wang, J ^a   Avant, D ^a   Green, D ^a   Seo, S ^a   Fisher, J ^a   Mulberg, A E ^a   McCune, S K ^a   Burckart, G J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; DIDANOSINE; DIFLUPREDNATE; FAMOTIDINE; FENOLDOPAM MESILATE; GADOBUTROL; HETASTARCH; LEVOTHYROXINE SODIUM; LINEZOLID; LOPINAVIR PLUS RITONAVIR; LUCINACTANT; MEROPENEM; NEOSTIGMINE METHYL SULFATE; NEVIRAPINE; NITRIC OXIDE; NITROPRUSSIDE SODIUM; OSELTAMIVIR; REMIFENTANIL; ROCURONIUM; SEVOFLURANE; STAVUDINE; DRUG;

BODY WEIGHT; CLINICAL PHARMACOLOGY; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG DOSE REGIMEN; DRUG EXPOSURE; DRUG INDICATION; DRUG LABELING; HUMAN; NEWBORN; PEDIATRICS; PREMATURITY; PRIORITY JOURNAL; REVIEW; AGE; ALGORITHM; BIOLOGICAL MODEL; CLINICAL TRIAL (TOPIC); COMPUTER SIMULATION; DOSE CALCULATION; DOSE RESPONSE; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; INFANT, NEWBORN, DISEASES; METABOLISM; PHARMACOKINETICS; RISK ASSESSMENT; RISK FACTOR;

AGE FACTORS; ALGORITHMS; CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DISCOVERY; DRUG DOSAGE CALCULATIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; INFANT, NEWBORN; INFANT, NEWBORN, DISEASES; MODELS, BIOLOGICAL; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; RISK ASSESSMENT; RISK FACTORS;

EID: 84946415361     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.149     Document Type: Review

References (22)

1. U.S. Food and Drug Administration: Guidance for Industry: General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm425885. pdf. Accessed January 27, 2015.
2. van den Anker, J. & Allegaert, K. Clinical pharmacology in neonates and young infants: the benefit of a population-tailored approach. Expert Rev. Clin. Pharmacol. 5, 5-8 (2012).
3. Allegaert, K., van de Velde, M. & van den Anker, J. Neonatal clinical pharmacology. Paediatr. Anaesth. 24, 30-38 (2014).
4. Davis, J.M., Connor, E.M. & Wood, A.J. The need for rigorous evidence on medication use in preterm infants: is it time for a neonatal rule? JAMA 308, 1435-1436 (2012).
5. Zlotnik Shaul, R. & Vitale, D. Can we afford it?: Ethical consideration of expensive drug treatment for neonates and infants. Clin. Pharmacol. Ther. 86, 587-589 (2009).
6. Hsieh, E.M. et al. Medication use in the neonatal intensive care unit. Am. J. Perinatol. 31, 811-821.
7. Laughon, M.M. et al. Innovative clinical trial design for pediatric therapeutics. Expert Rev. Clin. Pharmacol. 4, 643-652 (2011).
8. VIDEX (didanosine) pediatric powder for oral solution (prescribing information). Princeton, NJ: Bristol-Myers Squibb Company; 2014.
9. US Food and Drug Administration. Clinial Pharmacology for NDA 21251 (Kaletra). http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm072489. pdf. Accessed January 27, 2015.
10. Dunne, J. et al. Extrapolation of adult data and other data in pediatric drug-development programs. Pediatrics 128, e1242-1249 (2011).
11. Fike, F.B., Mortellaro, V.E., Pettiford, J.N., Ostlie, D.J. & St Peter, S.D. Diagnosis of gastroesophageal reflux disease in infants. Pediatr. Surg. Int. 27, 791-797 (2011).
12. Shakhnovich, V., Ward, R.M. & Kearns, G.L. Failure of proton pump inhibitors to treat GERD in neonates and infants: a question of drug, diagnosis, or design. Clin. Pharmacol. Ther. 92, 388-392 (2012).
13. Martin, A.J. et al. Natural history and familial relationships of infant spilling to 9 years of age. Pediatrics 109, 1061-1067 (2002).
14. Davidson, G. et al. Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients. J. Pediatr. 163, 692-698 e1-2 (2013).
15. Chen, I.L. et al. Proton pump inhibitor use in infants: FDA reviewer experience. J. Pediatr. Gastroenterol. Nutr. 54, 8-14 (2012).
16. US Food and Drug Administration. Summary Minutes of the Gastrointestinal Drugs Advisory Committee (GIDAC). http://www. fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/ucm195280.htm. (2010). Accessed December 24, 2014.
17. New Pediatric Labeling Information Database. US Food and Drug Administration website. http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd5labelingdatabase. Accessed December 24, 2014.
18. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). US Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049872. htm. Accessed December 24, 2014.
19. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA). US Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm316937.htm. Accessed December 24, 2014.
20. Summaries of Medical and Clinical Pharmacology Reviews. US Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm161894. htm. Accessed December 24, 2014.
21. Drugs@FDA. US Food and Drug Administration website. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed December 24, 2014.
22. Laughon, M.M. et al. Drug labeling and exposure in neonates. JAMA Pediatr. 168, 130-136 (2014).