# Latest **URL:** https://forum.certara.com/latest.md?page=1 [Latest](https://forum.certara.com/latest.md) · [Categories](https://forum.certara.com/categories.md) · [Tags](https://forum.certara.com/tags.md) **Page:** 2 --- ## [Possible false-positive DD0113 for AEBDSYCD MedDRA reference in Define-XML](https://forum.certara.com/t/possible-false-positive-dd0113-for-aebdsycd-meddra-reference-in-define-xml/4399)
**Author:** [@Jose\_Gonzalez](https://forum.certara.com/u/Jose_Gonzalez)\ **Replies:** 1\ **Last updated:** [May 29, 2026, 10:11pm UTC](https://forum.certara.com/t/possible-false-positive-dd0113-for-aebdsycd-meddra-reference-in-define-xml/4399 "2026-05-29T22:11:01Z")
Hello, We are receiving the following Pinnacle 21 finding: DD0113 - Missing MedDRA reference on AEBDSYCD variable However, after reviewing the generated define.xml, the MedDRA references appear to be correctly defin… --- ## [2026-03-30 SEND CT in p21c](https://forum.certara.com/t/2026-03-30-send-ct-in-p21c/4386)
**Author:** [@squid](https://forum.certara.com/u/squid)\ **Replies:** 4\ **Last updated:** [May 29, 2026, 9:36pm UTC](https://forum.certara.com/t/2026-03-30-send-ct-in-p21c/4386 "2026-05-29T21:36:08Z")
Hello! When can we expect 2026-03-30 SEND CT to become available in p21c? Thanks! --- ## [DD0113 Error in P21 for the SDTM Define](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 7\ **Last updated:** [May 29, 2026, 4:12pm UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369 "2026-05-29T16:12:36Z")
Hi Bianca, For questions related to Enterprise version, please try our P21 Enterprise support resources. However, based on your description it sounds like you have multiple MedDRA references in your define. Kind Regar… --- ## [About future ECLI](https://forum.certara.com/t/about-future-ecli/4390)
**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\ **Replies:** 1\ **Last updated:** [May 21, 2026, 2:47pm UTC](https://forum.certara.com/t/about-future-ecli/4390 "2026-05-21T14:47:52Z")
Dear All, Hi, I heard that Aspera Connect will be replaced by Aspera for Desktop in the upcoming P21E release. I think this change will affect ECLI. For example, we may need to specify a local path for the Aspera path, … --- ## [Access Issue with Pinnacle21 Community via Proxy Network](https://forum.certara.com/t/access-issue-with-pinnacle21-community-via-proxy-network/4395)
**Author:** [@SASAKI1](https://forum.certara.com/u/SASAKI1)\ **Replies:** 1\ **Last updated:** [May 20, 2026, 1:34pm UTC](https://forum.certara.com/t/access-issue-with-pinnacle21-community-via-proxy-network/4395 "2026-05-20T13:34:39Z")
Hello, I am currently trying to use Pinnacle21 Community, but I am unable to access the service when connected through a proxy network. In my environment, outbound connections are routed via a corporate proxy for secur… --- ## [New SDTM CT Version](https://forum.certara.com/t/new-sdtm-ct-version/4361)
**Author:** [@Fei](https://forum.certara.com/u/Fei)\ **Replies:** 3\ **Last updated:** [May 20, 2026, 1:32pm UTC](https://forum.certara.com/t/new-sdtm-ct-version/4361 "2026-05-20T13:32:51Z")
Now my SDTM CT Version is still 2024-09-27 and did not load the newer one, what do I need to do to get it to load, is it due to the fact that I’m in China and the internet is perhaps limiting resulting in this --- ## [NLME error population PK model](https://forum.certara.com/t/nlme-error-population-pk-model/4383)
**Author:** [@Harikrishna\_Devalapa](https://forum.certara.com/u/Harikrishna_Devalapa)\ **Replies:** 10\ **Last updated:** [May 15, 2026, 3:23pm UTC](https://forum.certara.com/t/nlme-error-population-pk-model/4383 "2026-05-15T15:23:42Z")
Hi All, I just recently run NLME in Phoenix and got below error. Error in Population: Error reading file C:\\Users\\HARIKR~1.DEV\\AppData\\Local\\Temp\\1\\Phoenix\\DME\_SI~1.605\\out000001.txt: File does not exist There are err… --- ## [Future Plans on Validation Rules related to DM.RACE/DM.ETHNIC](https://forum.certara.com/t/future-plans-on-validation-rules-related-to-dm-race-dm-ethnic/4394)
**Author:** [@harald.goldner](https://forum.certara.com/u/harald.goldner)\ **Replies:** 1\ **Last updated:** [May 13, 2026, 5:01pm UTC](https://forum.certara.com/t/future-plans-on-validation-rules-related-to-dm-race-dm-ethnic/4394 "2026-05-13T17:01:53Z")
Dear P21 Team, no urgent request, but I am curious if there are any plans to react to the following situation (in terms of validation rules), and if so, how: (1) FDA: Latest applicable and approved SDTM-IG is v3.4, req… --- ## [Question regarding DD0137 findings for TSVAL1 and TSVAL2 in Define.xml](https://forum.certara.com/t/question-regarding-dd0137-findings-for-tsval1-and-tsval2-in-define-xml/4392)
**Author:** [@Jose\_Gonzalez](https://forum.certara.com/u/Jose_Gonzalez)\ **Replies:** 0\ **Last updated:** [May 12, 2026, 6:03pm UTC](https://forum.certara.com/t/question-regarding-dd0137-findings-for-tsval1-and-tsval2-in-define-xml/4392 "2026-05-12T18:03:39Z")
Dear Certara/Pinnacle 21 Support Team, We are reviewing a Define.xml validation report and received the following findings: DD0137 – Invalid variable label value Variable: TSVAL1 Variable: TSVAL2 The rule message st… --- ## [Repeat comments when converting excel spec to define.xml](https://forum.certara.com/t/repeat-comments-when-converting-excel-spec-to-define-xml/1900)
**Author:** [@Matt\_Myers](https://forum.certara.com/u/Matt_Myers)\ **Replies:** 3\ **Last updated:** [May 12, 2026, 1:54pm UTC](https://forum.certara.com/t/repeat-comments-when-converting-excel-spec-to-define-xml/1900 "2026-05-12T13:54:29Z")
Hello Alex, This is due to a known issue where the def:CommentOID is being duplicated in the WhereClauseDef. Only corresponding ItemDef should have def:CommentOID. Our team is currently working on a fix for this issue … --- ## [DD0150 - Missing expected Standard, advise how to make the generator include the SDTMIG 3.3 def:Standard entry automatically?](https://forum.certara.com/t/dd0150-missing-expected-standard-advise-how-to-make-the-generator-include-the-sdtmig-3-3-def-standard-entry-automatically/4388)
**Author:** [@Jose\_Gonzalez](https://forum.certara.com/u/Jose_Gonzalez)\ **Replies:** 2\ **Last updated:** [May 11, 2026, 5:15pm UTC](https://forum.certara.com/t/dd0150-missing-expected-standard-advise-how-to-make-the-generator-include-the-sdtmig-3-3-def-standard-entry-automatically/4388 "2026-05-11T17:15:19Z")
Hi Certara/P21 Support, We are using Pinnacle 21 Community to generate a Define-XML 2.1 file for an SDTM study configured as SDTM-IG 3.3. The generated Define-XML is identified as SDTM-IG 3.3 in the ODM/FileOID and Met… --- ## [Phoenix version 8.8 has been released](https://forum.certara.com/t/phoenix-version-8-8-has-been-released/4387)
**Author:** [@SimonDavis](https://forum.certara.com/u/SimonDavis)\ **Replies:** 0\ **Last updated:** [May 1, 2026, 11:09am UTC](https://forum.certara.com/t/phoenix-version-8-8-has-been-released/4387 "2026-05-01T11:09:33Z")
Hello all! Phoenix version 8.8 has been released and is now available for download https://certara-phoenix.s3.us-east-1.amazonaws.com/Phoenix\_8.8.zip \> Do read the documentation and release notes for Phoenix 8.8 to ens… --- ## [PK-PD model of Binary repsonse](https://forum.certara.com/t/pk-pd-model-of-binary-repsonse/3630)
**Author:** [@ygsla](https://forum.certara.com/u/ygsla)\ **Replies:** 5\ **Last updated:** [April 20, 2026, 8:42pm UTC](https://forum.certara.com/t/pk-pd-model-of-binary-repsonse/3630 "2026-04-20T20:42:47Z")
HI Folks, Can we develop PK-PD model with binary reponse data in NLME? If yes, sharing some more information or suggestion or any built template will be appreciated. Thanks in advance!! Regards, Ygs --- ## [How to input iv dose at 0 and 8 hour every day for 10 days](https://forum.certara.com/t/how-to-input-iv-dose-at-0-and-8-hour-every-day-for-10-days/4379)
**Author:** [@Yong\_Li](https://forum.certara.com/u/Yong_Li)\ **Replies:** 0\ **Last updated:** [April 19, 2026, 2:34am UTC](https://forum.certara.com/t/how-to-input-iv-dose-at-0-and-8-hour-every-day-for-10-days/4379 "2026-04-19T02:34:34Z")
I am entry level. I want to learn how to input repeat dose, such as iv dose at 0 and 8 hour every day for 10 days. Thanks Yong --- ## [Box and Whisker plots - x-axis](https://forum.certara.com/t/box-and-whisker-plots-x-axis/4378)
**Author:** [@michael](https://forum.certara.com/u/michael)\ **Replies:** 1\ **Last updated:** [April 4, 2026, 11:21am UTC](https://forum.certara.com/t/box-and-whisker-plots-x-axis/4378 "2026-04-04T11:21:20Z")
I’m working on generating box plots in Phoenix WinNonlin (8.5.1.3) and was wondering if it’s possible to display a numeric (continuous) x-axis rather than the default categorical grouping. Specifically, I’d like to: P… --- ## [Phoenix Failed to create table: Could not load file or assembly, System.Data.SqlXml](https://forum.certara.com/t/phoenix-failed-to-create-table-could-not-load-file-or-assembly-system-data-sqlxml/4377)
**Author:** [@user3](https://forum.certara.com/u/user3)\ **Replies:** 0\ **Last updated:** [March 27, 2026, 8:49am UTC](https://forum.certara.com/t/phoenix-failed-to-create-table-could-not-load-file-or-assembly-system-data-sqlxml/4377 "2026-03-27T08:49:21Z")
Hi system, When I tried to run Phoenix’s built-in example file “C:\\Program Files (x86)\\Certara\\Phoenix\\application\\Examples\\Data and Plots\\Tables.phxproj”, it failed to run successfully. The “Warnings and Errors“ messag… --- ## [P21C Legacy SDTMIGv3.1.3 Validation](https://forum.certara.com/t/p21c-legacy-sdtmigv3-1-3-validation/4374)
**Author:** [@aurban](https://forum.certara.com/u/aurban)\ **Replies:** 2\ **Last updated:** [March 25, 2026, 8:46pm UTC](https://forum.certara.com/t/p21c-legacy-sdtmigv3-1-3-validation/4374 "2026-03-25T20:46:22Z")
I have a legacy SDTMIGv3.1.3 study which is planned for inclusion in an upcoming submission. eSUB package was unfortunately not created at the time of study completion. It seems FDA Legacy engine 2204.1 was the last ava… --- ## [Issue when download file: release/engine/engines\_v4.json](https://forum.certara.com/t/issue-when-download-file-release-engine-engines-v4-json/4372)
**Author:** [@Jeremy1](https://forum.certara.com/u/Jeremy1)\ **Replies:** 1\ **Last updated:** [March 24, 2026, 4:33pm UTC](https://forum.certara.com/t/issue-when-download-file-release-engine-engines-v4-json/4372 "2026-03-24T16:33:59Z")
Hi i try to use pinnacle21 cli, but i get this error, please can you help. Here the log java -jar "/Users/pinnacle/Documents/Pinnacle 21 Community/p21-client-1.0.8.jar" --engine.version='FDA 2304.3' --standard='stdm… --- ## [How to split Y-axis by Yvarname for plotting](https://forum.certara.com/t/how-to-split-y-axis-by-yvarname-for-plotting/4373)
**Author:** [@Jin\_Wang](https://forum.certara.com/u/Jin_Wang)\ **Replies:** 2\ **Last updated:** [March 18, 2026, 6:14pm UTC](https://forum.certara.com/t/how-to-split-y-axis-by-yvarname-for-plotting/4373 "2026-03-18T18:14:17Z")
Hi, I simulated some PKPD profiles using the literature model parameters in Phoenix 8.7. As shown in the plot for “Ind Simulation” below, the scales for different variables differ apart even with log Y-axis. Is there a … --- ## [Pinnacle 21 Community 4.1.0 ADAM Define Excel Specification using ADAMIG 1.2](https://forum.certara.com/t/pinnacle-21-community-4-1-0-adam-define-excel-specification-using-adamig-1-2/4370)
**Author:** [@Dipal\_Modi](https://forum.certara.com/u/Dipal_Modi)\ **Replies:** 2\ **Last updated:** [March 13, 2026, 12:33pm UTC](https://forum.certara.com/t/pinnacle-21-community-4-1-0-adam-define-excel-specification-using-adamig-1-2/4370 "2026-03-13T12:33:32Z")
We are getting an error while generating ADAM Define Excel specification from ADAM XPT files using ADAMIG - 1.2 --- ## [CV domain dataset label value](https://forum.certara.com/t/cv-domain-dataset-label-value/4369)
**Author:** [@SASAKI1](https://forum.certara.com/u/SASAKI1)\ **Replies:** 3\ **Last updated:** [March 10, 2026, 3:36pm UTC](https://forum.certara.com/t/cv-domain-dataset-label-value/4369 "2026-03-10T15:36:06Z")
After updating the engine and running validation on the define file only, the following issue was raised regarding the dataset label. In accordance with the SEND IG, we set the label of the CV domain to “Cardiovascular”… --- ## [Using observed baselines values as fixed parameter value](https://forum.certara.com/t/using-observed-baselines-values-as-fixed-parameter-value/3723)
**Author:** [@cmukashyaka](https://forum.certara.com/u/cmukashyaka)\ **Replies:** 2\ **Last updated:** [March 6, 2026, 5:15pm UTC](https://forum.certara.com/t/using-observed-baselines-values-as-fixed-parameter-value/3723 "2026-03-06T17:15:07Z")
Hello, I am working on an indirect response model (limited inhibition of Kin), I have baseline values for each subject measured at the start of study. I need to use these values and fix them as E0 where E0 = Kin/Kout so… --- ## [Pinnacle21 Community Version: 4.1.0で"No internet connection"が表示されます](https://forum.certara.com/t/pinnacle21-community-version-4-1-0-no-internet-connection/4366)
**Author:** [@Yasuhiro\_Masuzaki](https://forum.certara.com/u/Yasuhiro_Masuzaki)\ **Replies:** 2\ **Last updated:** [March 6, 2026, 12:30am UTC](https://forum.certara.com/t/pinnacle21-community-version-4-1-0-no-internet-connection/4366 "2026-03-06T00:30:26Z")
Pinnacle21 Community Version: 4.1.0をインストールしました。 起動すると“No internet connection”と表示されて最新情報にアクセスできません。 弊社IT部門とPinnacle21 Communityの利用について協議するために、Pinnacle21 Communityを起動した際の接続先情報をご教示していただけますでしょうか。 --- ## [Null Values in WhereClause Sheet](https://forum.certara.com/t/null-values-in-whereclause-sheet/4364)
**Author:** [@bosh.yang](https://forum.certara.com/u/bosh.yang)\ **Replies:** 4\ **Last updated:** [February 24, 2026, 6:12am UTC](https://forum.certara.com/t/null-values-in-whereclause-sheet/4364 "2026-02-24T06:12:51Z")
Dears, Is there any way to express null value in define.xml(see below) using P21 Community Standard template? In the define.xml above, I tried VSEVINTX EQ NULL and VSEVINTX EQ EMPTY, both doesn’t work, and then I tr… --- ## [PopPK Dataset Problem](https://forum.certara.com/t/poppk-dataset-problem/4367)
**Author:** [@Arturo\_Gomez](https://forum.certara.com/u/Arturo_Gomez)\ **Replies:** 2\ **Last updated:** [February 22, 2026, 11:15pm UTC](https://forum.certara.com/t/poppk-dataset-problem/4367 "2026-02-22T23:15:09Z")
Good morning, I have been performing non-compartmental analyses (NCA) with WinNonlin for approximately two years. More recently, I have started using the NLME module to conduct population pharmacokinetic analyses. I am … --- ## [Error in P21 when generating the ADaM define](https://forum.certara.com/t/error-in-p21-when-generating-the-adam-define/4308)
**Author:** [@anantha.khandavilli](https://forum.certara.com/u/anantha.khandavilli)\ **Replies:** 14\ **Last updated:** [February 17, 2026, 10:19am UTC](https://forum.certara.com/t/error-in-p21-when-generating-the-adam-define/4308 "2026-02-17T10:19:32Z")
Hi Team, Our team was working on an ADaM define for a study and encountered the following error in P21 when generating the define using the BMS inhouse template and seeing below error. They have checked the ADaM spec bu… --- ## [Analysis Results Metadata Multiple Parameters](https://forum.certara.com/t/analysis-results-metadata-multiple-parameters/4365)
**Author:** [@Kate1](https://forum.certara.com/u/Kate1)\ **Replies:** 0\ **Last updated:** [February 16, 2026, 2:28pm UTC](https://forum.certara.com/t/analysis-results-metadata-multiple-parameters/4365 "2026-02-16T14:28:04Z")
Hi all, I suspect this may have been raised before, apologies, but I wanted to check how the ParameterOID should be handled within the ARM for ADaM defines when multiple ADaMs are used in an analysis output. For example… --- ## [Pinnacle 21 Community has expired due to an extended period with no internet connection](https://forum.certara.com/t/pinnacle-21-community-has-expired-due-to-an-extended-period-with-no-internet-connection/1894)
**Author:** [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Replies:** 15\ **Last updated:** [February 13, 2026, 2:38pm UTC](https://forum.certara.com/t/pinnacle-21-community-has-expired-due-to-an-extended-period-with-no-internet-connection/1894 "2026-02-13T14:38:47Z")
Hi Leonid, You can re-install P21 Community. Kind Regards, Sergiy --- ## [DS中有知情同意的记录，但P21却报了 Message：DS域内没有取得受试者知情同意的记录?](https://forum.certara.com/t/ds-p21-message-ds/1729)
**Author:** [@fen.zhang](https://forum.certara.com/u/fen.zhang)\ **Replies:** 3\ **Last updated:** [February 11, 2026, 3:07am UTC](https://forum.certara.com/t/ds-p21-message-ds/1729 "2026-02-11T03:07:30Z")
Bonnie： 你好！感谢您向我们反馈这个bug。 这是由于Rule SD1240在中文环境下出错所致。我们会立即修复。 再次感谢！ PJ --- ## [INVALID ISO 8601 not throw error](https://forum.certara.com/t/invalid-iso-8601-not-throw-error/4363)
**Author:** [@Premkumar\_Prawinkuma](https://forum.certara.com/u/Premkumar_Prawinkuma)\ **Replies:** 1\ **Last updated:** [February 6, 2026, 6:45pm UTC](https://forum.certara.com/t/invalid-iso-8601-not-throw-error/4363 "2026-02-06T18:45:25Z")
Hi, i have scenario where Date is collected with YEAR and MONTH , No DAY collected , However Time collected. My program created date as 2026-02T09:00. i finally found that this is not per ISO 8601 Date format. it should… [Previous page](https://forum.certara.com/latest.md) [Next page](https://forum.certara.com/latest.md?page=2)