GAPPS (Grading and Assessment of Pharmacokinetic-Pharmacodynamic Studies) a critical appraisal system for antimicrobial PKPD studies – development and application in pediatric antibiotic studies

References

• O’Donnell CP, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics. 2002 Nov;110(5):e52.
   PubMed Web of Science ®Google Scholar
• Shah SS, Hall M, Goodman DM, et al. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med. 2007 Mar;161(3):282–290.
   PubMed Web of Science ®Google Scholar
• Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European network for drug investigation in children. BMJ. 2000 Jan 8;320(7227):79–82.
   PubMed Web of Science ®Google Scholar
• Versporten A, Bielicki J, Drapier N, et al. The worldwide antibiotic resistance and prescribing in european children (ARPEC) point prevalence survey: developing hospital-quality indicators of antibiotic prescribing for children. J Antimicrob Chemother. 2016 Jan 8;71:1106–1117.
   PubMed Web of Science ®Google Scholar
• Vernacchio L, Kelly JP, Kaufman DW, et al. Medication use among children <12 years of age in the United States: results from the slone survey. Pediatrics. 2009 Aug;124(2):446–454.
   PubMed Web of Science ®Google Scholar
• Amadeo B, Zarb P, Muller A, et al. European surveillance of antibiotic consumption (ESAC) point prevalence survey 2008: paediatric antimicrobial prescribing in 32 hospitals of 21 European countries. J Antimicrob Chemother. 2010 Oct;65(10):2247–2252.
   PubMed Web of Science ®Google Scholar
• Holstiege J, Schink T, Molokhia M, et al. Systemic antibiotic prescribing to paediatric outpatients in 5 European countries: a population-based cohort study. BMC Pediatr. 2014;14:174.
   PubMed Web of Science ®Google Scholar
• Lee GC, Reveles KR, Attridge RT, et al. Outpatient antibiotic prescribing in the United States: 2000 to 2010. BMC Med. 2014;12:96.
   PubMed Web of Science ®Google Scholar
• Rossignoli A, Clavenna A, Bonati M. Antibiotic prescription and prevalence rate in the outpatient paediatric population: analysis of surveys published during 2000–2005. Eur J Clin Pharmacol. 2007 Dec;63(12):1099–1106.
   PubMed Web of Science ®Google Scholar
• Spyridis N, Sharland M. The European Union antibiotic awareness day: the paediatric perspective. Arch Dis Child. 2008 Nov;93(11):909–910.
   PubMed Web of Science ®Google Scholar
• Zarb P, Coignard B, Griskeviciene J, et al. The European centre for disease prevention and control (ECDC) pilot point prevalence survey of healthcare-associated infections and antimicrobial use. Euro Surveill. 2012;17(46): 20316.
   PubMedGoogle Scholar
• Sachs AN, Avant D, Lee CS, et al. Pediatric information in drug product labeling. JAMA. 2012 May 09;307(18):1914–1915.
   PubMed Web of Science ®Google Scholar
• Frattarelli DA, Galinkin JL, Green TP, et al. Off-label use of drugs in children. Pediatrics. 2014 Mar;133(3):563–567.
   PubMed Web of Science ®Google Scholar
• Metsvaht T, Nellis G, Varendi H, et al. High variability in the dosing of commonly used antibiotics revealed by a Europe-wide point prevalence study: implications for research and dissemination. BMC Pediatr. 2015 Apr 16;15:41.
   PubMed Web of Science ®Google Scholar
• Ahmed U, Spyridis N, Wong IC, et al. Dosing of oral penicillins in children: is big child=half an adult, small child=half a big child, baby=half a small child still the best we can do? BMJ. 2011 Dec 15;343:d7803.
   PubMedGoogle Scholar
• Sharland M. Manual of childhood infections. 4th ed. New York (NY): Oxford University Press; 2016. ( Oxford specialist handbooks in paediatrics).
   Google Scholar
• Germovsek E, Kent A, Metsvaht T, et al. Development and evaluation of a gentamicin pharmacokinetic model that facilitates opportunistic gentamicin therapeutic drug monitoring in neonates and infants. Antimicrob Agents Chemother. 2016 Aug;60(8):4869–4877.
   PubMed Web of Science ®Google Scholar
• Standing JF. Understanding and applying pharmacometric modelling and simulation in clinical practice and research. Br J Clin Pharmacol. 2017 Feb;83(2):247–254.
   PubMed Web of Science ®Google Scholar
• van den Anker JN. Getting the dose of vancomycin right in the neonate. Int J Clin Pharmacol Ther. 2011 Apr;49(4):247–249.
   PubMed Web of Science ®Google Scholar
• Bartelink IH, Wolfs T, Jonker M, et al. Highly variable plasma concentrations of voriconazole in pediatric hematopoietic stem cell transplantation patients. Antimicrob Agents Chemother. 2013 Jan;57(1):235–240.
   PubMed Web of Science ®Google Scholar
• Germovsek E, Barker CI, Sharland M, et al. Scaling clearance in paediatric pharmacokinetics: all models are wrong, which are useful? Br J Clin Pharmacol. 2017 Apr;83(4):777–790.
   PubMed Web of Science ®Google Scholar
• Holford N, Heo YA, Anderson B. A pharmacokinetic standard for babies and adults. J Pharm Sci. 2013 Sept;102(9):2941–2952.
   PubMed Web of Science ®Google Scholar
• Paediatric Formulary Committee. BNF for children ( online). London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2019 [cited 2019 Aug 22]. Available from: http://www.medicinescomplete.com
   Google Scholar
• World Health Organization. Pocket book of hospital care for children guidelines for the management of common illnesses with limited resources. 2nd ed. World Health Organization; 2013. ISBN-13: 978-92-4-154837-3.
   Google Scholar
• AAP Committee on Infectious Diseases. Red book report of the committee on infectious diseases. 31st ed. American Academy of Pediatrics; 2018. ISBN 978-1-61002-146-3.
   Google Scholar
• van der Zanden TM, de Wildt SN, Liem Y, et al. Developing a paediatric drug formulary for the Netherlands. Arch Dis Child. 2017 Apr;102(4):357–361.
   PubMed Web of Science ®Google Scholar
• Kanji S, Hayes M, Ling A, et al. Reporting guidelines for clinical pharmacokinetic studies: the ClinPK statement. Clin Pharmacokinet. 2015 July;54(7):783–795.
   PubMed Web of Science ®Google Scholar
• Atkins D, Eccles M, Flottorp S, et al. Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches the GRADE working group. BMC Health Serv Res. 2004 Dec 22;4(1):38.
   PubMed Web of Science ®Google Scholar
• Barker CI, Standing JF, Turner MA, et al. Antibiotic dosing in children in Europe: can we grade the evidence from pharmacokinetic/pharmacodynamic studies - and when is enough data enough? Curr Opin Infect Dis. 2012 June;25(3):235–242.
   PubMed Web of Science ®Google Scholar
• Global Research in Paediatrics Network (GRiP). 2017. Available from: www.grip-network.org
   Google Scholar
• Kavanagh BP. The GRADE system for rating clinical guidelines. PLoS Med. 2009 Sept;6(9):e1000094.
   PubMed Web of Science ®Google Scholar
• Veltri MA, Neu AM, Fivush BA, et al. Drug dosing during intermittent hemodialysis and continuous renal replacement therapy: special considerations in pediatric patients. Paediatr Drugs. 2004;6(1):45–65.
   PubMedGoogle Scholar
• Zeilmaker GA, Pokorna P, Mian P, et al. Pharmacokinetic considerations for pediatric patients receiving analgesia in the intensive care unit; targeting postoperative, ECMO and hypothermia patients. Expert Opin Drug Metab Toxicol. 2018 Apr;14(4):417–428.
   PubMed Web of Science ®Google Scholar
• Zimmerman K, Gonzalez D, Swamy GK, et al. Pharmacologic studies in vulnerable populations: using the pediatric experience. Semin Perinatol. 2015 Nov;39(7):532–536.
   PubMed Web of Science ®Google Scholar
• Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modelling. Clin Pharmacokinet. 2008;47(4):231–243.
   PubMed Web of Science ®Google Scholar
• Germovsek E, Barker CIS, Sharland M, et al. Pharmacokinetic-pharmacodynamic modeling in pediatric drug development, and the importance of standardized scaling of clearance. Clin Pharmacokinet. 2019 Jan;58(1):39–52.
   PubMed Web of Science ®Google Scholar
• Rhodin MM, Anderson BJ, Peters AM, et al. Human renal function maturation: a quantitative description using weight and postmenstrual age. Pediatr Nephrol. 2009 Jan;24(1):67–76.
   PubMed Web of Science ®Google Scholar
• U.S. Department of Health and Human Services - Food and Drug Administration. Guidance for industry. Population pharmacokinetics. 1999.
   Google Scholar
• Wicha SG, Kees MG, Solms A, et al. TDMx: a novel web-based open-access support tool for optimising antimicrobial dosing regimens in clinical routine. Int J Antimicrob Agents. 2015 Apr;45(4):442–444.
   PubMed Web of Science ®Google Scholar
• Keizer RJ, Ter Heine R, Frymoyer A, et al. Model-informed precision dosing at the bedside: scientific challenges and opportunities. CPT Pharmacometrics Syst Pharmacol. 2018 Dec;7(12):785–787.
   PubMedGoogle Scholar
• Visser SA, de Alwis DP, Kerbusch T, et al. Implementation of quantitative and systems pharmacology in large pharma. CPT Pharmacometrics Syst Pharmacol. 2014 Oct 22;3:e142.
   PubMedGoogle Scholar
• Tatarinova T, Neely M, Bartroff J, et al. Two general methods for population pharmacokinetic modeling: non-parametric adaptive grid and non-parametric Bayesian. J Pharmacokinet Pharmacodyn. 2013 Apr;40(2):189–199.
   PubMed Web of Science ®Google Scholar
• Chan PL, Jacqmin P, Lavielle M, et al. The use of the SAEM algorithm in MONOLIX software for estimation of population pharmacokinetic-pharmacodynamic-viral dynamics parameters of maraviroc in asymptomatic HIV subjects. J Pharmacokinet Pharmacodyn. 2011 Feb;38(1):41–61.
   PubMed Web of Science ®Google Scholar
• Jansen-van der Weide MC, Caldwell PH, Young B, et al. Clinical trial decisions in difficult circumstances: parental consent under time pressure. Pediatrics. 2015 Oct;136(4):e983–92.
   PubMed Web of Science ®Google Scholar
• Laughon MM, Benjamin DK Jr, Capparelli EV, et al. Innovative clinical trial design for pediatric therapeutics. Expert Rev Clin Pharmacol. 2011 Sept;4(5):643–652.
   PubMedGoogle Scholar
• Ogungbenro K, Dokoumetzidis A, Aarons L. Application of optimal design methodologies in clinical pharmacology experiments. Pharm Stat. 2009 July-Sept;8(3):239–252.
   PubMed Web of Science ®Google Scholar
• Stockmann C, Barrett JS, Roberts JK, et al. Use of modeling and simulation in the design and conduct of pediatric clinical trials and the optimization of individualized dosing regimens. CPT Pharmacometrics Syst Pharmacol. 2015 Nov;4(11):630–640.
   PubMedGoogle Scholar
• European Medicines Agency. Guideline on reporting the results of population pharmacokinetic analyses. 2007. [cited 2019 Nov 25]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-results-population-pharmacokinetic-analyses_en.pdf
   Google Scholar
• Dykstra K, Mehrotra N, Tornoe CW, et al. Reporting guidelines for population pharmacokinetic analyses. J Pharmacokinet Pharmacodyn. 2015 June;42(3):301–314.
   PubMed Web of Science ®Google Scholar
• Byon W, Smith MK, Chan P, et al. Establishing best practices and guidance in population modeling: an experience with an internal population pharmacokinetic analysis guidance. CPT Pharmacometrics Syst Pharmacol. 2013 July 03;2:e51.
   PubMedGoogle Scholar
• ISoP. International society of pharmacometrics - standards and best practice committee. Available from: http://go-isop.org/committees/standards-best-practices-committee/
   Google Scholar
• The Lancet Infectious D. Antibiotic research priorities: ready, set, now go. Lancet Infect Dis. 2017;17(4):349.
   PubMed Web of Science ®Google Scholar