TABLE 2.

Clinical pharmacokinetic criteria for clinical PK studies

Checklist itema
Title
1. Title identifies drug(s) and patient population(s) studied
2. Abstract includes name of drug(s), route of administration, population, results of primary objective, and major clinical PK findings
Background
3. PK data that are known and relevant to study drugs are described
4. An explanation of the study rationale is provided
5. Specific objectives or hypotheses are provided
Methods
6. Eligibility criteria of study participants are described
7. Coadministration (or lack thereof) of study drug(s) with other potentially interacting drugs or food is described
8. Drug prepn and administration characteristics (including dose, route, formulation, infusion duration, and frequency) are described
9. Body fluid or tissue sampling for quantitative drug measurement is described
10. Validation of quantitative bioanalytical methods used in the study are referenced or described if applicable
11. PK modeling methods and software used are described, including assumptions made regarding no. of compartments and order of kinetics (zero, first, or mixed order)
12. For population PK studies, covariates incorporated into PK models are identified and described
13. Formulas for calculated variables (such as creatinine clearance, body surface area, AUC, and adjusted body wt) are provided or referenced
14. The specific body wt used in drug dosing and PK calculations are reported (i.e., ideal body wt vs actual body wt vs adjusted body wt)
15. Statistical methods, including software used, are described
Results
16. Study withdrawals or subjects lost to follow-up (or lack thereof) are reported
17. Quantification of missing or excluded data is provided if applicable
18. All relevant variables that may explain inter- and intrapatient PK variability are provided with appropriate measures of variance
19. Results of PK analyses are reported with appropriate measures of precision (such as ranges or 95% confidence intervals)
20. Studies in patients receiving extracorporeal drug removal (i.e., dialysis) should report the mode of drug removal, type of filters used, duration of therapy, and relevant flow rates
21. In studies of drug bioavailability comparing two formulations of the same drug, F, AUC, Cmax, and Tmax should be reported
Discussion
22. Study limitations describing potential sources of bias and imprecision, where relevant, should be described
23. The relevance of study findings (applicability and external validity) is described
Other information
24. Funding sources and conflicts of interest for the authors are disclosed

^aT_max, time to maximum concentration of drug in serum.