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Introduction to PKNCA: Automation of Noncompartmental Analysis in R (May 25th, Noon EDT)


#21

Answers:

@vijay Calculation speed: PKNCA takes minimal time (<=1 second) for most calculations in clinical studies (10s to 100s of subjects). For simulated data sets, it could take longer, but typically the NCA calculations would be faster than the simulations. Also, since PKNCA is R-based, it can likely be run on the same system doing the simulations.

@Tim_Nicholas Reporting: PKNCA does not have a reporting function beyond the summary function. There will likely be a future package that assists with reporting.

@Dinko_Rekic PKNCA currently calculates the AUC % extrapolated based on the Clast,observed only. In a future version, the user will have more control over the calculations and can choose. Can you please add this feature request to the GitHub issues page?

@ksl Currently, PKNCA does not allow for terminal point selection in half-life calculations. Can you please add this feature request to the GitHub issues page?


#22

Hi

Thanks for the nice demo. When the GUI will be available? Not all Clinical Pharmacologist are R users, so having a R-shiny app would be great.


#23

Hi @Vincent1,

I’m glad that you enjoyed the demo. If you have any questions about other specifics, let me know. A GUI is planned, but additional features of the main computational engine are planned first. I’ll likely do another training session/demo here when the GUI becomes available.

Have a great day,

Bill


#24

Hi Bill,

Thanks for your response. Do you think the GUI will be available in 2017?

Kind regards
Vincent


#25

Hi,

Is this R package “validated”? Can we use it to perform NCA analysis and submit it to Health Authorities Agencies?

Best regards
Vincent


#26

Hi Vincent,

Validation is a very long topic. The quick answer is, yes, you can use PKNCA to perform NCA for regulatory submissions.

The longer answer is, companies can use any tool that they want to submit data. The every regulatory agency that I know has accepted regulatory submissions from many NCA tools. For any submission, it is the responsibility of the sponsor to ensure the validation of their tools whether internally-written or from an external source. For their own official analyses, my understanding is that the FDA uses internally written SAS and R scripts.

Thanks,

Bill


#27

Dear ,

Do you know the R code to estimate AUC beyond t ? I have utilized this code pk.calc.auc(conc, time, interval = c(0, 12), lambda.z =), but it doesn’t work.

Thank you,


#28

Dear @Abeer_Alharbi,

I’m not sure that I understand the question. PKNCA estimates the parameter based on the data in the interval. If you want the AUCinf, you should be using pk.calc.auc.inf. Can you please re-ask the question with a reproducible example (including the result you’d expect) in the GitHub issues (https://github.com/billdenney/pknca/issues)?

Thanks,

Bill


#29

Thank you for your response.The problem is solved.