# Latest **URL:** https://forum.certara.com/latest.md?page=3 [Latest](https://forum.certara.com/latest.md) · [Categories](https://forum.certara.com/categories.md) · [Tags](https://forum.certara.com/tags.md) **Page:** 4 --- ## [RSABE - 95%UCB estimation for Highly variable Drugs\_FDA](https://forum.certara.com/t/rsabe-95-ucb-estimation-for-highly-variable-drugs-fda/3576)
**Author:** [@d\_nil](https://forum.certara.com/u/d_nil)\ **Replies:** 5\ **Last updated:** [August 29, 2025, 11:21am UTC](https://forum.certara.com/t/rsabe-95-ucb-estimation-for-highly-variable-drugs-fda/3576 "2025-08-29T11:21:14Z")
Dear Team, Is there any provision to determine Reference scaled average bioequivalence for Highly variable drugs? In which, We are interested to calculate 95% Upper confidence bound. The parameter in which we are inter… --- ## [How to appropriately cite Phoenix products](https://forum.certara.com/t/how-to-appropriately-cite-phoenix-products/2804)
**Author:** [@vivaturi](https://forum.certara.com/u/vivaturi)\ **Replies:** 7\ **Last updated:** [August 29, 2025, 8:09am UTC](https://forum.certara.com/t/how-to-appropriately-cite-phoenix-products/2804 "2025-08-29T08:09:53Z")
Can someone provide a standard way to cite the use Phoenix in reports/publications etc. Is it different for citing NLME vs NCA vs IVIVC etc.. Thanks Vijay --- ## [Unexpected Data Row Reordering After Reopening Phoenix NLME Project](https://forum.certara.com/t/unexpected-data-row-reordering-after-reopening-phoenix-nlme-project/4322)
**Author:** [@Bhim\_Bahadur](https://forum.certara.com/u/Bhim_Bahadur)\ **Replies:** 2\ **Last updated:** [August 27, 2025, 11:04am UTC](https://forum.certara.com/t/unexpected-data-row-reordering-after-reopening-phoenix-nlme-project/4322 "2025-08-27T11:04:36Z")
Dear Members, I’m working on a PopPK model in Phoenix NLME using a dataset of 86 subjects, including both SAD and MAD data. Here’s a summary of my workflow: Verified all numeric and textual data. Filtered the dataset … --- ## [How to translate Monolix Combined 1 ( additive + proportional) error model in Phoenix](https://forum.certara.com/t/how-to-translate-monolix-combined-1-additive-proportional-error-model-in-phoenix/4310)
**Author:** [@Bhim\_Bahadur](https://forum.certara.com/u/Bhim_Bahadur)\ **Replies:** 2\ **Last updated:** [August 23, 2025, 3:55am UTC](https://forum.certara.com/t/how-to-translate-monolix-combined-1-additive-proportional-error-model-in-phoenix/4310 "2025-08-23T03:55:18Z")
Hi, I am trying to replicate a published PopPK model built in Monolix with Combined1 error model: There we get additive and proportional error value. However, in Phoenix we have addi+multi error model as: observe(CO… --- ## [Getting secondary PK parameters](https://forum.certara.com/t/getting-secondary-pk-parameters/4318)
**Author:** [@sabdulm1](https://forum.certara.com/u/sabdulm1)\ **Replies:** 1\ **Last updated:** [August 13, 2025, 6:17pm UTC](https://forum.certara.com/t/getting-secondary-pk-parameters/4318 "2025-08-13T18:17:55Z")
Hello, Hope everyone is doing well! I have a project I am working on with both intense and sparse PK sampling. I was able to find a good model fit (2 compartment, additive, with enterohepatic recirculation) and that se… --- ## [Pirana 25.7.1 Release Announcement](https://forum.certara.com/t/pirana-25-7-1-release-announcement/4319)
**Author:** [@kniefort](https://forum.certara.com/u/kniefort)\ **Replies:** 1\ **Last updated:** [August 12, 2025, 5:48pm UTC](https://forum.certara.com/t/pirana-25-7-1-release-announcement/4319 "2025-08-12T17:48:15Z")
We are very pleased to announce the release of Pirana 25.7.1! Pirana is a pharmacometrics (PMX) workbench solution that coordinates the use of multiple tools to add efficiency, organization, and quality to PMX workflows… --- ## [How to build a Zero order absorption 2-cmt with Saturable nonlinear absorption model in NLME for Oral dose?](https://forum.certara.com/t/how-to-build-a-zero-order-absorption-2-cmt-with-saturable-nonlinear-absorption-model-in-nlme-for-oral-dose/4302)
**Author:** [@Bhim\_Bahadur](https://forum.certara.com/u/Bhim_Bahadur)\ **Replies:** 2\ **Last updated:** [August 7, 2025, 10:38am UTC](https://forum.certara.com/t/how-to-build-a-zero-order-absorption-2-cmt-with-saturable-nonlinear-absorption-model-in-nlme-for-oral-dose/4302 "2025-08-07T10:38:51Z")
I want to create a zero order 2 compartmental model with saturable absorption to address the nonlinear PK. Kindly help me to design the script. I have drafted but there is an issue that the Predicted keeps on going up up… --- ## [ℹ️ Phoenix 8.6 - Faster optimization for parameters with ADPO](https://forum.certara.com/t/phoenix-8-6-faster-optimization-for-parameters-with-adpo/4269)
**Author:** [@SimonDavis](https://forum.certara.com/u/SimonDavis)\ **Replies:** 4\ **Last updated:** [August 7, 2025, 7:34am UTC](https://forum.certara.com/t/phoenix-8-6-faster-optimization-for-parameters-with-adpo/4269 "2025-08-07T07:34:16Z")
Phoenix 8.6 is now available for download, as well as the corresponding Integral 25.4.1 plug-in if required. If you are a hosted Phoenix customer please contact support to be scheduled for upgrading. https://help.certa… --- ## [P21C - Define Error occurring with Custom Columns](https://forum.certara.com/t/p21c-define-error-occurring-with-custom-columns/4313)
**Author:** [@Samantha\_Brown](https://forum.certara.com/u/Samantha_Brown)\ **Replies:** 1\ **Last updated:** [August 5, 2025, 2:24pm UTC](https://forum.certara.com/t/p21c-define-error-occurring-with-custom-columns/4313 "2025-08-05T14:24:22Z")
Some background - Utilizing the P21’s ADaM specification template, I have added custom columns in the right-most area of both the Variable and ValueLevel tabs. These columns house excel formulas to help ensure Methods m… --- ## [Diagnosis Group in TS domain](https://forum.certara.com/t/diagnosis-group-in-ts-domain/4311)
**Author:** [@Siru\_Zhou](https://forum.certara.com/u/Siru_Zhou)\ **Replies:** 1\ **Last updated:** [August 4, 2025, 8:27pm UTC](https://forum.certara.com/t/diagnosis-group-in-ts-domain/4311 "2025-08-04T20:27:05Z")
One of the TS domain Validation rule is : IF healthy volunteers = “N” then TDIGRP must be present and not null. Here is a phase 1 study, the population is Subjects with Mild and Moderate Hepatic Impairment , and the obje… --- ## [Units in Phoenix Modeling](https://forum.certara.com/t/units-in-phoenix-modeling/2585)
**Author:** [@jdeng415](https://forum.certara.com/u/jdeng415)\ **Replies:** 4\ **Last updated:** [August 4, 2025, 3:04am UTC](https://forum.certara.com/t/units-in-phoenix-modeling/2585 "2025-08-04T03:04:07Z")
Dear Experts, When using pheonix to model data, I have found that sometimes the units in the “theta” results worksheet does not always come out right. How do you specify units in pheonix modeling? I know that you can use… --- ## [Changing Output units for V and Cl](https://forum.certara.com/t/changing-output-units-for-v-and-cl/2295)
**Author:** [@jmcdowell](https://forum.certara.com/u/jmcdowell)\ **Replies:** 7\ **Last updated:** [July 18, 2025, 9:20pm UTC](https://forum.certara.com/t/changing-output-units-for-v-and-cl/2295 "2025-07-18T21:20:18Z")
Dear All, this seems like such a silly question but I can’t seem to find the answer in any documentation. My input is conc in ng/mL and time is in minutes so I’m getting V in mL and Cl in mL/min. However, I desire the re… --- ## [How to Overlay Observed Data on NLME Simulation Plot](https://forum.certara.com/t/how-to-overlay-observed-data-on-nlme-simulation-plot/4283)
**Author:** [@Yook\_Noh](https://forum.certara.com/u/Yook_Noh)\ **Replies:** 4\ **Last updated:** [July 18, 2025, 8:27pm UTC](https://forum.certara.com/t/how-to-overlay-observed-data-on-nlme-simulation-plot/4283 "2025-07-18T20:27:41Z")
Hi there, I’m currently working on an NLME simulation job. I used a mixed-effects model to simulate the steady-state PK profile and reviewed the Ind Simulation plot in the output. The plot shows only the simulated conce… --- ## [ℹ️ New Pirana Certification Course - Starts 25 August 2025](https://forum.certara.com/t/new-pirana-certification-course-starts-25-august-2025/4297)
**Author:** [@ana.henry](https://forum.certara.com/u/ana.henry)\ **Replies:** 0\ **Last updated:** [July 18, 2025, 5:19pm UTC](https://forum.certara.com/t/new-pirana-certification-course-starts-25-august-2025/4297 "2025-07-18T17:19:39Z")
Get certified in the used of Pirana, a powerful model management tool widely utilized in pharmacometric modeling and simulation. This is the first time that Certara University offers a Live on-line certification course … --- ## [Bioavailability of prodrug vs parent drug](https://forum.certara.com/t/bioavailability-of-prodrug-vs-parent-drug/4287)
**Author:** [@PWXYZE](https://forum.certara.com/u/PWXYZE)\ **Replies:** 1\ **Last updated:** [July 18, 2025, 11:33am UTC](https://forum.certara.com/t/bioavailability-of-prodrug-vs-parent-drug/4287 "2025-07-18T11:33:33Z")
We are looking to calculate the bioavailability of a prodrug as compared to the parent drug. We have calculated the NCA parameters for each individually (parent drug IV, parent drug PO, prodrug PO), but I’m not sure how … --- ## [PK analysis for brain tissue](https://forum.certara.com/t/pk-analysis-for-brain-tissue/4288)
**Author:** [@PWXYZE](https://forum.certara.com/u/PWXYZE)\ **Replies:** 0\ **Last updated:** [July 11, 2025, 7:52pm UTC](https://forum.certara.com/t/pk-analysis-for-brain-tissue/4288 "2025-07-11T19:52:57Z")
We would like to do PK analysis for brain tissue, but the only model types in WinNonlin are plasma and urine. Can I apply one of these models to brain tissue or is there another way to perform this PK analysis in WinNonl… --- ## [Modeling between period variation](https://forum.certara.com/t/modeling-between-period-variation/4274)
**Author:** [@phychadelicpk](https://forum.certara.com/u/phychadelicpk)\ **Replies:** 5\ **Last updated:** [July 3, 2025, 9:39pm UTC](https://forum.certara.com/t/modeling-between-period-variation/4274 "2025-07-03T21:39:30Z")
Hi all, I got a bunch of studies, that include MAD and cross over studies of different dose levels. Just looking at the plots there appears to be cyp induction that you would only see in the more drawn out studies. I as… --- ## [About SD1448 Rule](https://forum.certara.com/t/about-sd1448-rule/4266)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 1\ **Last updated:** [June 26, 2025, 7:43pm UTC](https://forum.certara.com/t/about-sd1448-rule/4266 "2025-06-26T19:43:45Z")
Hi All, This is Minji. I validated SDTM with SDTM IG 3.3 configuration using P21C PMDA2411.0 engine and FDA 2405.2. Rule ID SD1448 validation result was generated when LBSTRESC was “142.”. However, I think that SD1448… --- ## [Pinnacle 21 Community has expired due to an extended period with no internet](https://forum.certara.com/t/pinnacle-21-community-has-expired-due-to-an-extended-period-with-no-internet/4265)
**Author:** [@Kristina\_Levi](https://forum.certara.com/u/Kristina_Levi)\ **Replies:** 0\ **Last updated:** [June 19, 2025, 1:03pm UTC](https://forum.certara.com/t/pinnacle-21-community-has-expired-due-to-an-extended-period-with-no-internet/4265 "2025-06-19T13:03:57Z")
Hello, Pinnacle21 Community 4.1.0 fails to run from the command line giving the following message in the log: CLI.3.17::Pinnacle 21 Community has expired due to an extended period with no internet connection. Connect t… --- ## [SV domain: SVOCCUR caused an error message in SDTMIG 3.3 - SD0058: Variable appears in dataset, but is not in SDTM model](https://forum.certara.com/t/sv-domain-svoccur-caused-an-error-message-in-sdtmig-3-3-sd0058-variable-appears-in-dataset-but-is-not-in-sdtm-model/4246)
**Author:** [@Linda\_Li](https://forum.certara.com/u/Linda_Li)\ **Replies:** 4\ **Last updated:** [June 17, 2025, 2:08pm UTC](https://forum.certara.com/t/sv-domain-svoccur-caused-an-error-message-in-sdtmig-3-3-sd0058-variable-appears-in-dataset-but-is-not-in-sdtm-model/4246 "2025-06-17T14:08:11Z")
Hello, I included SDTMIG 3.4 new SV domain variables SVPRESP, SVOCCUR, SVREASOC, SVCNTMOD, SVEPCHGI in the SV domain, which used the older version SDTMIG 3.3 version, and received an error message “SD0058: Variable appe… --- ## [Pinnacle21 4.1 Offline Use Recommendations](https://forum.certara.com/t/pinnacle21-4-1-offline-use-recommendations/4258)
**Author:** [@Zach\_Rooney](https://forum.certara.com/u/Zach_Rooney)\ **Replies:** 2\ **Last updated:** [June 16, 2025, 3:59pm UTC](https://forum.certara.com/t/pinnacle21-4-1-offline-use-recommendations/4258 "2025-06-16T15:59:08Z")
Hello, What are your recommendations for running Pinnacle 21 C in a secure environment? We have been using P21 C in a secure environment and manually installing the newest version every 6 months. The latest installer, … --- ## [Engine FDA (2405.2) Potential Validation Bugs](https://forum.certara.com/t/engine-fda-2405-2-potential-validation-bugs/4257)
**Author:** [@harald.goldner](https://forum.certara.com/u/harald.goldner)\ **Replies:** 1\ **Last updated:** [June 16, 2025, 3:45pm UTC](https://forum.certara.com/t/engine-fda-2405-2-potential-validation-bugs/4257 "2025-06-16T15:45:33Z")
Hi there, I just wanted to bring to attention that recently performed some Validations on SDTM-IG 3.2 (FDA) as well as SDTM-IG 3.4 (FDA) where encountered 2 validation findings which I would consider bugs. (1) CT2002: … --- ## [Is P21C able to validate BIMO Package, or it can only be validated by P21E?](https://forum.certara.com/t/is-p21c-able-to-validate-bimo-package-or-it-can-only-be-validated-by-p21e/4256)
**Author:** [@Siru\_Zhou](https://forum.certara.com/u/Siru_Zhou)\ **Replies:** 1\ **Last updated:** [June 16, 2025, 1:43pm UTC](https://forum.certara.com/t/is-p21c-able-to-validate-bimo-package-or-it-can-only-be-validated-by-p21e/4256 "2025-06-16T13:43:33Z")
Is P21C able to validate BIMO Package, or it can only be validated by P21E? --- ## [Controlled Terminology Best Practices](https://forum.certara.com/t/controlled-terminology-best-practices/1658)
**Author:** [@inna](https://forum.certara.com/u/inna)\ **Replies:** 0\ **Last updated:** [March 3, 2021, 8:57pm UTC](https://forum.certara.com/t/controlled-terminology-best-practices/1658 "2021-03-03T20:57:49Z")
We recently hosted a webinar on Controlled Terminology Best Practices where Sarah Angelo walked us through the different types of controlled terminology, the reasons why controlled terminology is needed, common problems … --- ## [Mapping Considerations for Screen Failure, Not Assigned, and Not Treated Subjects](https://forum.certara.com/t/mapping-considerations-for-screen-failure-not-assigned-and-not-treated-subjects/1534)
**Author:** [@inna](https://forum.certara.com/u/inna)\ **Replies:** 0\ **Last updated:** [June 18, 2020, 1:55pm UTC](https://forum.certara.com/t/mapping-considerations-for-screen-failure-not-assigned-and-not-treated-subjects/1534 "2020-06-18T13:55:53Z")
Our recent webinar Confusing Validation Rules Explained sparked lots of follow-up questions from you. So we created a series of blog posts to address those questions. The first post in this series will clarify the best p… --- ## [SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?](https://forum.certara.com/t/sdtm-trial-summary-domain-puzzle-are-these-the-right-pieces/1741)
**Author:** [@pjohnston](https://forum.certara.com/u/pjohnston)\ **Replies:** 0\ **Last updated:** [September 11, 2021, 12:54am UTC](https://forum.certara.com/t/sdtm-trial-summary-domain-puzzle-are-these-the-right-pieces/1741 "2021-09-11T00:54:08Z")
We recently hosted a webinar on SDTM Trial Summary (TS) where Kristin Kelly discussed the minimum set of parameters to include in this essential domain and how to avoid triggering FDA rejection criteria. If you missed i… --- ## [ADNCA.PCSTRESU codelist](https://forum.certara.com/t/adnca-pcstresu-codelist/4242)
**Author:** [@john.chen](https://forum.certara.com/u/john.chen)\ **Replies:** 1\ **Last updated:** [June 6, 2025, 2:41pm UTC](https://forum.certara.com/t/adnca-pcstresu-codelist/4242 "2025-06-06T14:41:10Z")
Hi, When I ran the validation for the ADaM define file alone, the following two messages were returned: Term/NCI Code mismatch in Codelist ‘PK Units of Measure (PC)’ NCI Code ‘C85494’ for Codelist ‘PK Units of Measu… --- ## [Please adjust QSMETHOD CT2002 validation rule](https://forum.certara.com/t/please-adjust-qsmethod-ct2002-validation-rule/4225)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 2\ **Last updated:** [June 5, 2025, 12:09am UTC](https://forum.certara.com/t/please-adjust-qsmethod-ct2002-validation-rule/4225 "2025-06-05T00:09:59Z")
Hi All, This is Minji. I validated SDTM with SDTM IG 3.3 configuration using P21C PMDA2411.0 engine and FDA 2405.2. A Rule ID CT2002 validation was run under Method CT for the QSMETHOD variable. It looks like QRSMTHOD… --- ## [NCA for intravenous bolus injection](https://forum.certara.com/t/nca-for-intravenous-bolus-injection/4214)
**Author:** [@Nicolas\_Yazigi](https://forum.certara.com/u/Nicolas_Yazigi)\ **Replies:** 5\ **Last updated:** [June 4, 2025, 11:55am UTC](https://forum.certara.com/t/nca-for-intravenous-bolus-injection/4214 "2025-06-04T11:55:10Z")
Hi, I am currently working on a non-compartmental analysis (NCA) of a study involving iron sucrose (injectable solution, 100 mg/5 mL), administered as an intravenous bolus injection over 5 minutes. In this context, time … --- ## [Question: Can I include a codelist in Define.xml for an empty variable that wasn’t collected in the CRF?](https://forum.certara.com/t/question-can-i-include-a-codelist-in-define-xml-for-an-empty-variable-that-wasn-t-collected-in-the-crf/4226)
**Author:** [@a.shtaiwi](https://forum.certara.com/u/a.shtaiwi)\ **Replies:** 1\ **Last updated:** [June 3, 2025, 8:05pm UTC](https://forum.certara.com/t/question-can-i-include-a-codelist-in-define-xml-for-an-empty-variable-that-wasn-t-collected-in-the-crf/4226 "2025-06-03T20:05:51Z")
Hi everyone, I have a quick question I hope someone can help me about it! In my SDTM dataset, I have a variable (e.g., QEVAL) that: Is included in the dataset structure (it appears as a column), Has all null values (… [Previous page](https://forum.certara.com/latest.md?page=2) [Next page](https://forum.certara.com/latest.md?page=4)