Reporting a population pharmacokinetic-pharmacodynamic study: A journal's perspective

Clinical Pharmacokinetics

Volumn 53, Issue 2, 2014, Pages 111-122

  Jamsen, Kris M ^a   McLeay, Sarah C ^a   Barras, Michael A ^b   Green, Bruce ^a  

^a Model Answers Pty Ltd   (Australia)

^b ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

CHECKLIST; CLINICAL TRIAL (TOPIC); DRUG BIOAVAILABILITY; DRUG RESEARCH; HUMAN; LIMIT OF QUANTITATION; PHARMACIST; PHARMACODYNAMICS; PHARMACOKINETICS; POPULATION; POPULATION RESEARCH; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REPRODUCIBILITY; REVIEW; WORK;

BIOMEDICAL RESEARCH; DATA INTERPRETATION, STATISTICAL; HUMANS; MODELS, BIOLOGICAL; PHARMACOKINETICS; PUBLISHING; RESEARCH DESIGN;

EID: 84893306062     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-013-0114-1     Document Type: Review

References (24)

1. Wade JR, Edholm M, Salmonson T. A guide for reporting the results of population pharmacokinetic analyses: a Swedish perspective. AAPS J. 2005;7:456-60.
2. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). http://www.ich.org.
3. McLeay SC, Morrish GA, Kirkpatrick CMJ, Green B. The relationship between drug clearance and body size: systematic review and meta-analysis of the literature published from 2000 to 2007. Clin Pharmacokinet. 2012;51(5):319-30.
4. Committee for Medicinal Products for Human Use, European Medicines Agency. Draft guideline on reporting the results of population pharmacokinetic analyses [online]. http://www.emea.eu.int/pdfs/human/ewp/18599006en.pdf. Accessed 28 Dec 2006.
5. Brendel K, Dartois C, Comets E, Lemenuel-Diot A, Laveille C, Tranchand B, Girard P, Laffont CM, Mentré F. Are population pharmacokinetic and/or pharmacodynamics models adequately evaluated? Clin Pharmacokinet. 2007;46(3):221-34.
6. Beal SL, Boeckmann AJ, Sheiner LB. NONMEM users guide. Parts I-VIII ICON Development Solutions.
7. Mould DR, Upton RN. Basic concepts in population modeling, simulation, and model-based drug development. CPT Pharmacometrics Syst Pharmacol. 2012;1:e6. doi: 10.1038/psp.2012.4.
8. Mould DR, Upton RN. Basic concepts in population modeling, simulation, and model-based drug development - part 2: introduction to pharmacokinetic modeling methods. CPT Pharmacometrics Syst Pharmacol. 2013;2:e38. doi: 10.1038/psp.2013.14.
9. Holford N. A time to event tutorial for pharmacometricians. CPT Pharmacometrics Syst Pharmacol. 2013;2:e43. doi: 10.1038/psp.2013.18.
10. Byon W, Smith MK, Chan P, Tortorici MA, Riley S, Dai H, Dong J, Ruiz-Garcia A, Sweeney K, Cronenberger C. Establishing best practices and guidance in population modeling: an experience with an internal population pharmacokinetic analysis guidance. CPT Pharmacometrics Syst Pharmacol. 2013;2:e51. doi: 10.1038/psp.2013.26.
11. Karlsson MO, Mentre F. Best practices in population modeling should always be evolving. CPT Pharmacometrics Syst Pharmacol. 2013;2:e52. doi: 10.1038/psp.2013.37.
12. Young JM, Solomon MJ. How to critically appraise an article. Nat Clin Pract Gastroenterol Hepatol. 2009;6(2):82-91.
13. Fowkes FGR, Fulton PM. Critical appraisal of published research: introductory guidelines. BMJ. 1991;302:1136-40.
14. Melina R, Kibbe MD. How to write a paper. ANZ J Surg. 2013;83(1-2):90-2.
15. Knottnerus JA, Tugwell P. How to write a research paper. J Clin Epidemiol. 2013;66(4):353-4.
16. Masic I. Ethical aspects and dilemmas of preparing, writing and publishing of the scientific papers in the biomedical journals. Acta Inform Med. 2012;20(3):141-8.
17. Popham K, Calo WA, Carpentier MY, Chen NE, Kamrudin SA, Le YCL, Skala KA, Thornton LR, Mullen PD. Reporting guidelines: optimal use in preventive medicine and public health. Am J Prev Med. 2012;43(4):e31-42.
18. Davidson A, McD Taylor D, Babl FE. Review article: a primer for clinical researchers in the emergency department: part III. How to write a scientific paper. Emerg Med Australas. 2012;24(4):357-62.
19. Lin P, Kuo Y. A guide to write a scientific paper for new writers. Microsurgery. 2012;32(1):80-5.
20. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Ann Intern Med. 2010;2010(152):726-32.
21. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet. 1999;354:1896-900.
22. Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. BMJ. 2003;326:41-4.
23. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007;147:573-7.
24. Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) Group. JAMA. 2000;283:2008-12.