Skip to main content
Log in

Pharmacokinetic and Pharmacodynamic Data Collection in Children and Neonates

A Quiet Frontier

  • Leading Article
  • Published:
Clinical Pharmacokinetics Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

References

  • Alpert BS, Lewins MJ, Rowland DW, Grant MJA, Olley PM, et al. Plasma indomethacin levels in preterm newborn infants with symptomatic patent ductus arteriosus: clinical and echocardiographic assessments of response. Journal of Pediatrics 95: 578–582, 1979

    Article  PubMed  CAS  Google Scholar 

  • American Academy of Pediatrics Committee on Drugs. General guidelines for the evaluation of drugs to be approved for use during pregnancy and for treatment of infants and children: a report of the Committee on Drugs, American Academy of Pediatrics to the Food and Drug Administration, US Department of Health, Education and Welfare, pp. 1–40, American Academy of Pediatrics, Chicago, 1974

    Google Scholar 

  • American Academy of Pediatrics Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 60: 91–101, 1977

    Google Scholar 

  • Baird-Lambert J, Doyle PE, Thomas D, Cvejic M, Buchanan H. Pharmacokinetics of cefotaxime in neonates. Journal of Antimicrobial Chemotherapy 13: 471–477, 1984

    Article  PubMed  CAS  Google Scholar 

  • Chandler MH, Clifton GD, Louis BA, Coons SJ, Foster TS, et al. Home monitoring of theophylline levels: a novel therapeutic approach. Pharmacotherapy 10: 294–300, 1990

    PubMed  CAS  Google Scholar 

  • DiStefano JJ. Optimized blood sampling protocols and sequential design of kinetic experiments. American Journal of Physiology 240: R259–R265, 1981

    PubMed  CAS  Google Scholar 

  • Drusano GL, Forrest A, Snyder MJ, Reed MD, Blumer JL. An evaluation of optimal sampling strategy and adaptive study design. Clinical Pharmacology and Therapeutics 44: 232–238, 1988

    Article  PubMed  CAS  Google Scholar 

  • Gal P, Ransom JL, Schall S, Weaver RL, Bird A, Brown Y. Indomethacin for patent ductus arteriosus closure: application of serum concentrations and pharmacodynamics to improve response. Journal of Perinatology 10: 20–26, 1990

    PubMed  CAS  Google Scholar 

  • Gal P, Ransom JL, Weaver RL. Gentamicin in neonates: the need for loading doses. Journal of Perinatology 7: 254–257, 1990

    Article  CAS  Google Scholar 

  • Gersony WM, Peckham GJ, Ellison RC, Miettinen OS, Nadas AS. Effects of indomethacin in premature infants with patent ductus arteriosus: results of a national collaborative study. Journal of Pediatrics 102: 895–906, 1983

    Article  PubMed  CAS  Google Scholar 

  • Gilman JT. Carbamazepine dosing for pediatric seizure disorders: the highs and lows. DICP: Annals of Pharmacotherapy 25: 1109–1112, 1991

    PubMed  CAS  Google Scholar 

  • Gilman JT, Gal P. Inadequacy of FDA dosing guidelines for theophylline use in neonates. Drug Intelligence and Clinical Pharmacy 20: 482–484, 1986

    Google Scholar 

  • Gilman JT, Gal P, Duchowny MS, Weaver RL, Ransom JL. Rapid sequential phenobarbital treatment of neonatal seizures. Pediatrics 83: 674–678, 1989

    PubMed  CAS  Google Scholar 

  • Gualtieri CT, Hicks RE, Patrick K, Schroeder SR, Breese GR, et al. Clinical correlates of methylphenidate blood levels. Therapeutic Drug Monitoring 6: 379–392, 1984

    Article  PubMed  CAS  Google Scholar 

  • Haughey DB, Hilligoss DM, Grassi A, Schentag JJ. Two-compartment gentamicin pharmacokinetics in premature neonates: a comparison to adults with decreased glomerular filtration rates. Journal of Pediatrics 96: 325–330, 1980

    Article  PubMed  CAS  Google Scholar 

  • Hedges LV, Olkin I. Statistical methods for meta-analysis, Academic Press, New York, 1985

    Google Scholar 

  • Hendeles L, Weinberger M. Theophylline: a ‘state of the art’ review. Pharmacotherapy 3: 2–44, 1983

    PubMed  CAS  Google Scholar 

  • Houghton GW, Richens A, Toseland PA, Davidson S, Falconer MA. Brain concentrations of phenytoin, phenobarbitone, and primidone in epileptic patients. European Journal of Clinical Pharmacology 9: 73–78, 1975

    Article  PubMed  CAS  Google Scholar 

  • Institute of Medicine. Drug development and the pediatric population: report of a workshop. National Academy Press, Washington, 1991

    Google Scholar 

  • Kauffman RE, Kearns GL. Pharmacokinetic studies in paediatric patients: clinical and ethical considerations. Clinical Pharmacokinetics 23: 10–29, 1992

    Article  PubMed  CAS  Google Scholar 

  • Kearns GL, Hilman BC, Wilson JT. Dosing implications of altered gentamicin disposition in patients with cystic fibrosis. Journal of Pediatrics 100: 312–318, 1982

    Article  PubMed  CAS  Google Scholar 

  • Kelly HW, Menendez R, Fan L, Murphy S. Pharmacokinetics of tobramycin in cystic fibrosis. Journal of Pediatrics 100: 318–321, 1982

    Article  PubMed  CAS  Google Scholar 

  • Klein JO, Feigin RD, McCracken GH. Report of the task force on diagnosis and management of meningitis. Pediatrics 78 (Suppl.): 959–982, 1986

    PubMed  CAS  Google Scholar 

  • Koren G. Ethical boundaries of medical research in infants and children in the 80s: analysis of rejected protocols and a new solution for drug studies. Developmental Pharmacology and Therapeutics 15: 130–141, 1990

    PubMed  CAS  Google Scholar 

  • Koren G, Silverman E, Sundel R, Edney P, Newburger JW, et al. Decreased protein binding of salicylates in Kawasaki disease. Journal of Pediatrics 118: 456–459, 1991

    Article  PubMed  CAS  Google Scholar 

  • Kupietz SS, Winsberg BG, Szerd J. Learning ability and methylphenidate (Ritalin®) plasma concentration in hyperkinetic children; a preliminary investigation. Journal American Academy of Child Psychiatry 21: 27–30, 1982

    Article  CAS  Google Scholar 

  • Lockman LA, Kriel R, Zaske D, Thompson T, Virnig N. Phenobarbital dosage for control of neonatal seizures. Neurology 29: 1445–1449, 1979

    Article  PubMed  CAS  Google Scholar 

  • Moore RD, Smith CR, Lietman PS. The association of aminoglycoside plasma levels with mortality in patients with gramnegative bacteremia. Journal of Infectious Disease 149: 443–448, 1984

    Article  CAS  Google Scholar 

  • Murphy MG, Peck C, Conner D, Zamani K, Merenstein GB, et al. Transcutaneous theophylline collection in preterm infants. Clinical Pharmacology and Therapeutics 47: 427–434, 1990

    Article  PubMed  CAS  Google Scholar 

  • Muttitt SC, Tierney AJ, Finer NN. The dose response of theophylline in the treatment of apnea of prematurity. Journal of Pediatrics 112: 115–121, 1988

    Article  PubMed  CAS  Google Scholar 

  • Onishi S, Yoshihi O, Nishimura Y, Itoh S, Isobe K, et al. Distribution of phenobarbital in serum, brain and other organs from pediatric patients. Developmental Pharmacology and Therapeutics 7: 153–159, 1984

    PubMed  CAS  Google Scholar 

  • Painter MJ, Pippenger CE, Wasterlein C, Barmada M, Pitlick W, et al. Phenobarbital and phenytoin in neonatal seizures: metabolism and tissue distribution. Neurology 31: 1107–1112, 1981

    Article  PubMed  CAS  Google Scholar 

  • Painter MJ, Pippenger C, MacDonald H, Pitlick W. Phenobarbital and diphenylhydantoin levels in neonates with seizures. Journal of Pediatrics 92: 315–319, 1978

    Article  PubMed  CAS  Google Scholar 

  • Payne K, Mattheyse FJ, Leibenberg D, Dawes T. The pharmacokinetics of midazolam in paediatric patients. European Journal of Clinical Pharmacology 37: 267–272, 1989

    Article  PubMed  CAS  Google Scholar 

  • Pitlick W, Painter M, Pippenger C. Phenobarbital pharmacokinetics in neonates. Clinical Pharmacology and Therapeutics 23: 346–350, 1978

    PubMed  CAS  Google Scholar 

  • Powell C, Painter MJ, Pippenger CE. Primidone therapy in refractory neonatal seizures. Journal of Pediatrics 105: 651–653, 1984

    Article  PubMed  CAS  Google Scholar 

  • Scheffner D, Konig St, Rautergerg-Ruland I, Kochen W, Hofmann WJ, et al. Fatal liver failure in 16 children with valproate therapy. Epilepsia 29: 530–542, 1988

    Article  PubMed  CAS  Google Scholar 

  • Shaywitz SE, Hunt RD, Jatlow P, Cohen DJ, Young JG, et al. Psychopharmacology of attention deficit disorder: pharmacokinetic, neuroendrocrine, and behavorial measures following acute and chronic treatment with methylphenidate. Pediatrics 69: 688–694, 1982

    PubMed  CAS  Google Scholar 

  • Sherwin AL, Eisen AA, Sokolowski CD. Anticonvulsant drugs in human epileptogenic brain. Archives of Neurology 29: 73–77, 1973

    Article  PubMed  CAS  Google Scholar 

  • Thomson AH, Way S, Bryson SM, McGovern EM, Kelman AW, et al. Population pharmacokinetics of gentamicin in neonates. Developmental Pharmacology and Therapeutics 11: 173–179, 1988

    PubMed  CAS  Google Scholar 

  • Tolia V, Brennan S, Aravind MK, Kauffman RE. Pharmacokinetic and pharmacodynamic study of midazolam in children during esophagogastroduodenoscopy. Journal of Pediatrics 119: 467–471, 1991

    Article  PubMed  CAS  Google Scholar 

  • Watterberg KL, Kelly HW, Angelus P, Backstrom C. The need for a loading dose of gentamicin in neonates. Therapeutic Drug Monitoring 11: 16–20, 1989

    Article  PubMed  CAS  Google Scholar 

  • Wells TG, Trang JM, Brown AL, Marmer BC, Jacobs RF. Cefotaxime therapy of bacterial meningitis in children. Journal of Antimicrobial Agents and Chemotherapy 14 (Suppl. B): 181–189, 1984

    Google Scholar 

  • Willis J. Use of theophylline in infants. FDA Drug Bulletin 15: 16–17, 1985

    Google Scholar 

  • Wilson JT. Pragmatic assessment of medicines available for young children and pregnant or breast-feeding women. In Morselli et al. (Eds) Basic and therapeutic aspects of perinatal pharmacology, pp. 76–112, Raven Press, New York, 1977

    Google Scholar 

  • Zaloga GP. Evaluation of bedside testing options for the critical care unit. Chest 97: 185S–190S, 1990

    PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Gilman, J.T., Gal, P. Pharmacokinetic and Pharmacodynamic Data Collection in Children and Neonates. Clin. Pharmacokinet. 23, 1–9 (1992). https://doi.org/10.2165/00003088-199223010-00001

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00003088-199223010-00001

Navigation