PHX WNL QA_13April20.. - Pharsight

More documents

Recommendations

Info

Q: When import the data from out exls. how to delete the unnecessary information and how to match the form WNL required? The import Wizard in Phoenix allows you to indicate the rows to import from an Excel file. I will attach the phoenix project that was partially shown in the webinar if you want to see some additional details. You will need to have Phoenix WinNonlin installed even if you don’t have license. Q: What does Pharsight recommend as calculation estimation: linear up/log down, or other? I (Ana) can only speak for myself but my opinion is that if you had to pick a default estimation the best would be the general linear up/log down because it accounts for several bumps on the data and also for log-estimation on the decay part of the curve which is especially important if the data are considerably spread out. However, with rich datasets when the data was collected relatively close to each other the 4 methods will give you very similar results and one should just document what was use for reproducibility but I doubt it would change any major conclusion. Q: Why does my version number show as 1.0 on my NCA core output? Our QA Dept. is complaining that it used to be there and is not anymore! The core output for NCA still shows the core version number 1.0 (right at the beginning). This version applies to the NCA analysis engine (the “core”), which is unchanged since 2007. The NCA engine is one of many analysis engines implemented in WNL/PHX WNL. The NCA user interface has changed but the engines behind it are stable and remain the same. See screenshot However, we realize that this could be confusing so we have entered a defect to make sure that the version of the software is shown in this output in the future. Q: 半衰期是采用消除相的 3 个点做的吗 ?Google Translation: ‘Elimination phase half-life is the use of 3 points to do?’
Yes, the default algorithm (best fit) in Phoenix WinNonlin has the requirement that at least 3 points are included for the lambdaz calculation and these points should NOT include Cmax. These rules can be overwritten by the user if a manual selection is done. I hope we interpreted your question correctly. Question about Pharsight Modeling Language Q: Do you present PML in another separately? There is no current plan to have a webinar about PML. However, we cover PML writing in all of our training courses and we provide a specific PML guide. Also the user can use build-in models or graphical models and the PML code is generated automatically as a starting point. The PML language is probably closer to C and fairly intuitive. Dan Weiner is also translating his PK/PD Data Analysis book using PML and we will inform you when this is published. IF you have specific question, please join the forum and several users are always happy to help. www.pharsight.com\extranet Q: We don't have this new version installed so don’t know how detail the PML language reference is. Do you have any book or manual on this topic? Please contact support@pharsight.com for the topics discussed in the guide. Also Daniel Weiner will be soon publishing an updated edition of his book ‘Pharmacokinetic & Pharmacodynamic Data Analysis’ (Fifth edition) with all the exercises translated to PML. We will also plan on providing some comparative documentation between WNL5 language and PML and post it in the forum www.pharsight.com/extranet but have not had the time yet. Questions on Validation Q: Is the Validation Suite output acceptable to auditors, for example FDA, EMEA etc. or should additional validation tests be performed? The FDA will not comment on the acceptability of tools used to accomplish computer system validation, because whether the Validation Suite output is acceptable or not will depend on how a particular user (i.e., Pharsight customer) uses the Validation Suite application. A user should first define the requirements for a computer system, e.g., Phoenix WinNonlin 6.2 implemented in a user’s environment. Then, the user should determine what testing will be accomplished to demonstrate the satisfactory implementation of the documented requirements. If the Validation Suite test cases will adequately test the functionality defined in the user’s requirements specification, then no additional testing would need to be done. But, if there are requirements that are not adequately tested by the Validation Suite tests, then the user should define and execute additional testing.
Page 1 and 2: Q&A Session The State-Of-The-Art So
Page 3 and 4: Pricing Questions Q: If I already h
Page 5 and 6: Q: How do you use the BLQ tool? Can
Page 7: No, Phoenix WinNonlin cannot model

PHX WNL QA_13April20.. - Pharsight

Create successful ePaper yourself

Delete template?

Save as template?