IQnca: a lot of questions :)

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Aline Fuchs

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Jan 25, 2022, 4:13:52 AMJan 25
to IQR Tools Users Group

Dear IQ Team,

I am currently implementing a NCA workflow with IQnca (which I like very much!). I have some (a lot 😊) questions / clarification on IQnca:

1.      NCA can only be performed in absolute dose. Why not to allow normalized doses (e.g. mg/kg)? do you plan a version with this feature?

2.      Is it possible to get this tables under a csv format as well? table_summary_byGROUP_pkparameters_IQnca,

table_summary_acrossGROUP_pkparameters_IQnca and

listing_pkparameter_IQnca

3.      How final unit of PK parameters are selected? is it based on dose unit and other units (concentration) are transformed to match dose unit?

4.      In IQdataNCA specification:

a.      What is “asis”? What is the difference by setting “missing” or “asis” in FLGBLQPR, FLGBLQIN, FLGBLQP1, FLGBLQPO, FGBQPLIN and FGBQPLOG arguments

b.      In FGBQ on PLIN and FGBQPLOG: I guess that asCONC is the value provided in ACONC e.g. the lab value provided even if < LLOQ ?

c.      FLGBLQP1 and FLGBLQPO: would 0 or missing would lead to the same results for NCA?

5.      Definition of NTIME = “Nominal time since first dose”

a.      in case of an NCA after multiple dose, is steady-state achievement identified for analysis? or steady-state is considered based on what is provided in PROFTIME argument?

b.      Examples 5, table 4.51  it  seems than NTIME is defined based on last dose rather than on first dose for multiple dosing? what is correct to do ?

6.     Can we add other covariate than those listed in workflow, table 3.1 ?

7.     Missing measurements

a.      For BLQ data embedded between 2 measurable time point: to exclude it, should it be set to “missing” ?

b.     I have a dataset with missing measurements. You mentioned in section 3.2.1 Ignored observations that All observations with missing concentration will be flagged to be ignored from summaries and NCA. In my dataset, the missing concentration are NA. But with this, I obtain an error when I want to plot the data plot(dataNCA, filename = "InitialExploration.pdf")

Error in if (!logY | d$LLOQ[1] > 0) { :   missing value where TRUE/FALSE neededHow to indicate correctly in the dataset the missing concentration?

8.     From mice, one full profile over time is made from several mice and with 3 measurements per time point. When one concentration over 3 point is BLQ, would you advise to set to 0 and get the mean of the 3 concentration or to exclude the BLQ measurement and get the mean from 2 points ‘

9.     In figure_summary….

a.      For mean  or geomean, how are handle missing or BLQ data? If one over measurement s BLQ, is mean performed based on what was decided on BLQ flag in IQnca specification ?

b.     Are summary dataset saved somewhere, can I extract them?


Thanks a lot already  !

Stefan Wetzel

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Feb 6, 2022, 11:19:02 PMFeb 6
to fuchs...@gmail.com, iqr-tools-...@intiquan.com, Henning Schmidt
Dear Aline,

Thank you for your email and the positive feedback. We are delighted to hear that you work with IQnca and like it. 
We also appreciate your feedback and the questions you sent.

As you may know, we do provide IQnca for free and try to provide some support via this email list.
As IQnca is for free, however, we are limited in the support we can offer; basically our colleagues do this when there is no project work or, in some cases, even outside of work. 
At the moment we are very busy with client projects, though. We will still do our best and try to answer as many of your questions as possible. 
We kindly ask you to be patient as this will likely take longer than one or two weeks; in particular as the list is quite extensive. 

We will get back to you as soon as possible

Kind regards,


Stefan

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