# Latest

**URL:** https://forum.certara.com/latest.md

[Latest](https://forum.certara.com/latest.md) · [Categories](https://forum.certara.com/categories.md) · [Tags](https://forum.certara.com/tags.md)

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## [Welcome to Certara! 👋](https://forum.certara.com/t/welcome-to-certara/5)

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**Author:** [@system](https://forum.certara.com/u/system)\
**Replies:** 0\
**Last updated:** [October 4, 2024, 8:48am UTC](https://forum.certara.com/t/welcome-to-certara/5 "2024-10-04T08:48:24Z")

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We are so glad you joined us. Certara A place to discuss Certara Products. Want a demo? Let’s Talk. We’re eager to share and ready to listen. Here are some things you can do to get started: :speaking\_head: Introduce…

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## [SD1076 Model Permissible variable added into standard domainについて](https://forum.certara.com/t/sd1076-model-permissible-variable-added-into-standard-domain/4428)

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**Author:** [@tonoki-yuta1](https://forum.certara.com/u/tonoki-yuta1)\
**Replies:** 0\
**Last updated:** [October 5, 2026, 3:57am UTC](https://forum.certara.com/t/sd1076-model-permissible-variable-added-into-standard-domain/4428 "2026-10-05T03:57:37Z")

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Engine FDA 2508.1 を使用して SENDIG-DARTのSEND バリデーションを実施したところ、以下の Message が出力されます。 SD1076 Model Permissible variable added into standard domain 指摘対象は SUPP–の QORIG です。 QORIG はSUPPの標準変数として定義されていると理解しており、標準ドメインへ追加された Model Pe…

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## [Unexpected warning define 2.1 (SEND 3.1.1)](https://forum.certara.com/t/unexpected-warning-define-2-1-send-3-1-1/4427)

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**Author:** [@sergio.garofalo](https://forum.certara.com/u/sergio.garofalo)\
**Replies:** 1\
**Last updated:** [September 22, 2026, 1:45pm UTC](https://forum.certara.com/t/unexpected-warning-define-2-1-send-3-1-1/4427 "2026-09-22T13:45:11Z")

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Hi all, While validating a Define-XML file, I encountered some unexpected warnings related to Origin Type: BW, BWNOMLBL, Other DD0073 Invalid Origin Type value BW, BWREASEX, Not Available DD0073 Invalid Origin …

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## [LBSTREFC about SD1076, SD1078 rule IDs](https://forum.certara.com/t/lbstrefc-about-sd1076-sd1078-rule-ids/4425)

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**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\
**Replies:** 2\
**Last updated:** [September 18, 2026, 12:12am UTC](https://forum.certara.com/t/lbstrefc-about-sd1076-sd1078-rule-ids/4425 "2026-09-18T00:12:31Z")

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Hi All, In P21C PMDA (2411.1) & FDA (2508.1) SDTM IG V3.3 engines, though LBSTREFC is expected variable in SDTM IG V3.3, false positive findings occurred. Please fix it. Thank you.

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## [NCA Multiple Dose with Different Dosing Interval - Feasible within WNL?](https://forum.certara.com/t/nca-multiple-dose-with-different-dosing-interval-feasible-within-wnl/3693)

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**Author:** [@aramisrojas](https://forum.certara.com/u/aramisrojas)\
**Replies:** 1\
**Last updated:** [September 17, 2026, 5:44pm UTC](https://forum.certara.com/t/nca-multiple-dose-with-different-dosing-interval-feasible-within-wnl/3693 "2026-09-17T17:44:21Z")

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Hello everybody, I’m running an NCA for the following study design for a customer: Phase 1 randomized study to assess pharmacokinetics of multiple (MAD) ascending doses of oral drug X in healthy participants. The endp…

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## [P21 community application Update notification](https://forum.certara.com/t/p21-community-application-update-notification/4424)

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**Author:** [@Swatilekha\_Banerjee](https://forum.certara.com/u/Swatilekha_Banerjee)\
**Replies:** 2\
**Last updated:** [September 14, 2026, 6:51pm UTC](https://forum.certara.com/t/p21-community-application-update-notification/4424 "2026-09-14T18:51:52Z")

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Users are getting errors while auto update of Pinnacle 21 community. Please Advise.

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## [Terminal BLQ Values and AUCinf Estimation](https://forum.certara.com/t/terminal-blq-values-and-aucinf-estimation/4419)

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**Author:** [@Mohamed\_Dabour](https://forum.certara.com/u/Mohamed_Dabour)\
**Replies:** 2\
**Last updated:** [August 14, 2026, 6:24pm UTC](https://forum.certara.com/t/terminal-blq-values-and-aucinf-estimation/4419 "2026-08-14T18:24:49Z")

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In a DDI study that included 27 subjects, our analyte was assessed with and without a co-administered drug for 0-120 h. The analyte was not detectable in any subject after 24 h and was detected in only 6–8 subjects at th…

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## [Copy Model Text for a Built in PK Model?](https://forum.certara.com/t/copy-model-text-for-a-built-in-pk-model/4417)

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**Author:** [@\_Laboratory\_for\_Syst](https://forum.certara.com/u/_Laboratory_for_Syst)\
**Replies:** 1\
**Last updated:** [August 14, 2026, 6:12pm UTC](https://forum.certara.com/t/copy-model-text-for-a-built-in-pk-model/4417 "2026-08-14T18:12:17Z")

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Hi, I am working on a QSP model. I have fit the PK separately using the built-in PK model (#4, first order absorption and elimination, single-compartment with lag time, parameterized on clearance) to obtain PK paramete…

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## [Pinnacle 21 Community 4.2.0 is here, and this one requires a manual install](https://forum.certara.com/t/pinnacle-21-community-4-2-0-is-here-and-this-one-requires-a-manual-install/4422)

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**Author:** [@Trevor\_Mankus](https://forum.certara.com/u/Trevor_Mankus)\
**Replies:** 0\
**Last updated:** [August 13, 2026, 12:17pm UTC](https://forum.certara.com/t/pinnacle-21-community-4-2-0-is-here-and-this-one-requires-a-manual-install/4422 "2026-08-13T12:17:24Z")

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Pinnacle 21 Community 4.2.0 is now available for Windows. A Mac build is on the way, and we’ll update this post as soon as it’s out. Please read before you update. Unlike previous releases, 4.2.0 will not arrive through…

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## [Incompatible CLI error](https://forum.certara.com/t/incompatible-cli-error/4421)

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**Author:** [@Michael\_Wasko](https://forum.certara.com/u/Michael_Wasko)\
**Replies:** 1\
**Last updated:** [August 13, 2026, 5:19am UTC](https://forum.certara.com/t/incompatible-cli-error/4421 "2026-08-13T05:19:37Z")

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I installed a new copy of Pinnacle21 community. When I run a dataset a report is generated noting an incompatible CLI. This is odd for a brand new installation, downloaded from the certara page. Engine FDA 2508.1 was …

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## [Covariate exploration in crossover model](https://forum.certara.com/t/covariate-exploration-in-crossover-model/4413)

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**Author:** [@Bruno\_Pypendop](https://forum.certara.com/u/Bruno_Pypendop)\
**Replies:** 6\
**Last updated:** [August 4, 2026, 10:04pm UTC](https://forum.certara.com/t/covariate-exploration-in-crossover-model/4413 "2026-08-04T22:04:24Z")

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I have a PK model for which I would like to include a period (occasion) effect then explore whether a categorical covariate may also have an effect. There is overlap since the categorical covariate is related to the admi…

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## [About SD1344 rule](https://forum.certara.com/t/about-sd1344-rule/4410)

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**Author:** [@minji.lee](https://forum.certara.com/u/minji.lee)\
**Replies:** 3\
**Last updated:** [July 7, 2026, 7:53pm UTC](https://forum.certara.com/t/about-sd1344-rule/4410 "2026-07-07T19:53:36Z")

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Hi, When the length of CM.CMCLAS exceeds $200, the data should be truncated within $200. This results in an SD1344 (Value for CMDECOD not found in WHODrug dictionary) validation finding. Could you please adjust the va…

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## [Pinnacle 21 community keeps updating to pre-release 4.2.0-snapshot. Pinnacle ID not working](https://forum.certara.com/t/pinnacle-21-community-keeps-updating-to-pre-release-4-2-0-snapshot-pinnacle-id-not-working/4409)

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**Author:** [@akistner](https://forum.certara.com/u/akistner)\
**Replies:** 1\
**Last updated:** [June 29, 2026, 2:26pm UTC](https://forum.certara.com/t/pinnacle-21-community-keeps-updating-to-pre-release-4-2-0-snapshot-pinnacle-id-not-working/4409 "2026-06-29T14:26:45Z")

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Hi, So, I don’t know why but Pinnacle21 community keeps updating to a prelease 4.2.0-snapshot version - I don’t really want to be a pre-release… I want to be on stable. I’ve tried once already to uninstall and reinstall…

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## [Follow for Latest Phoenix release information](https://forum.certara.com/t/follow-for-latest-phoenix-release-information/3495)

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**Author:** [@SimonDavis](https://forum.certara.com/u/SimonDavis)\
**Replies:** 24\
**Last updated:** [June 24, 2026, 10:17am UTC](https://forum.certara.com/t/follow-for-latest-phoenix-release-information/3495 "2026-06-24T10:17:55Z")

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Hopefully everyone received the email yesterday announcing that 8.3 is now available; https://lp.certara.com/Download-Phoenix-8.3.html Once you install this you may look under the help menu to find the release notes an…

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## [Bootstrap failures after upgrading Phoenix (8.5 → 8.8) in 2×2 crossover PopPK model Phoenix NLME](https://forum.certara.com/t/bootstrap-failures-after-upgrading-phoenix-8-5-8-8-in-2x2-crossover-poppk-model-phoenix-nlme/4389)

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**Author:** [@Bhim\_Bahadur](https://forum.certara.com/u/Bhim_Bahadur)\
**Replies:** 4\
**Last updated:** [June 24, 2026, 10:16am UTC](https://forum.certara.com/t/bootstrap-failures-after-upgrading-phoenix-8-5-8-8-in-2x2-crossover-poppk-model-phoenix-nlme/4389 "2026-06-24T10:16:20Z")

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Hello everyone, I am facing a bootstrap issue in Phoenix NLME after upgrading from version 8.5 to 8.8 and would appreciate insights from others who may have encountered similar behavior. Background I am working on a 2…

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## [Potential Define 2.1 Validation bugs with rules DD0004, DD0007, DD0011, and DD0124](https://forum.certara.com/t/potential-define-2-1-validation-bugs-with-rules-dd0004-dd0007-dd0011-and-dd0124/1914)

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**Author:** [@system](https://forum.certara.com/u/system)\
**Replies:** 3\
**Last updated:** [June 16, 2026, 6:30pm UTC](https://forum.certara.com/t/potential-define-2-1-validation-bugs-with-rules-dd0004-dd0007-dd0011-and-dd0124/1914 "2026-06-16T18:30:53Z")

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In my personal opinion, the DD0004 message you obtain is a false positive: there is indeed no (at least CDISC) rule that says that def:HasNoData is not allowed on ValueList-ItemRef|s. I consider this as an over-interpret…

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## [OmegaStderr and thetacorrelation and covariance output are coming up empty on one of my drugs](https://forum.certara.com/t/omegastderr-and-thetacorrelation-and-covariance-output-are-coming-up-empty-on-one-of-my-drugs/4402)

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**Author:** [@sabdulm1](https://forum.certara.com/u/sabdulm1)\
**Replies:** 3\
**Last updated:** [June 11, 2026, 4:01pm UTC](https://forum.certara.com/t/omegastderr-and-thetacorrelation-and-covariance-output-are-coming-up-empty-on-one-of-my-drugs/4402 "2026-06-11T16:01:21Z")

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Hello, Hope you’re all doing great! I am running PopPK models for two analytes, with multi dose PK. Drug one is a long half-life drug (20-30 days) and multiple absorption peaks (potential enterohepatic recirculation), …

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## [Csv version only in WHODD mar 2026](https://forum.certara.com/t/csv-version-only-in-whodd-mar-2026/4371)

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**Author:** [@flight](https://forum.certara.com/u/flight)\
**Replies:** 3\
**Last updated:** [June 11, 2026, 4:47am UTC](https://forum.certara.com/t/csv-version-only-in-whodd-mar-2026/4371 "2026-06-11T04:47:17Z")

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Pinnacle 21 Community supports version.txt only, is there any plan to release a new version? or any workaround here? Thanks!

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## [P21C v4.2.0 update](https://forum.certara.com/t/p21c-v4-2-0-update/4404)

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**Author:** [@David\_Roulstone](https://forum.certara.com/u/David_Roulstone)\
**Replies:** 1\
**Last updated:** [June 10, 2026, 2:43pm UTC](https://forum.certara.com/t/p21c-v4-2-0-update/4404 "2026-06-10T14:43:44Z")

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Hi, Last week P21C v4.1.0 was trying to update, I think it was trying to update to v4.2.0 but it would not update successfully. Do you know when v4.2.0 will be available? Thanks, David

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## [How to change the range of the x and y axis on plots like iPRED vs. IWRES?](https://forum.certara.com/t/how-to-change-the-range-of-the-x-and-y-axis-on-plots-like-ipred-vs-iwres/4405)

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**Author:** [@\_Laboratory\_for\_Syst](https://forum.certara.com/u/_Laboratory_for_Syst)\
**Replies:** 1\
**Last updated:** [June 9, 2026, 4:46pm UTC](https://forum.certara.com/t/how-to-change-the-range-of-the-x-and-y-axis-on-plots-like-ipred-vs-iwres/4405 "2026-06-09T16:46:16Z")

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Right now, all of the outputs are plotted on the same axes, but they clearly shouldn’t. How can I adjust the axes to better represent the outputs, which are on different scales?

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## [P21C: DD0029: false positives when CodedValue contains asterisks in an ADaM define.xml but not in an SDTM define.xml](https://forum.certara.com/t/p21c-dd0029-false-positives-when-codedvalue-contains-asterisks-in-an-adam-define-xml-but-not-in-an-sdtm-define-xml/4403)

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**Author:** [@Wouter](https://forum.certara.com/u/Wouter)\
**Replies:** 1\
**Last updated:** [June 4, 2026, 2:17pm UTC](https://forum.certara.com/t/p21c-dd0029-false-positives-when-codedvalue-contains-asterisks-in-an-adam-define-xml-but-not-in-an-sdtm-define-xml/4403 "2026-06-04T14:17:12Z")

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When running P21C validation on an ADaM define.xml, DD0029 is reporting false positives when the CodedValue contains an asterisk (\*). Example: In CDISC CT the codelist “PK Units of Measure” (C25613) contains value “h\*p…

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## [P21 Community Define spec generation assigns AE.AESTDTC as text instead of partialDateTime](https://forum.certara.com/t/p21-community-define-spec-generation-assigns-ae-aestdtc-as-text-instead-of-partialdatetime/4401)

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**Author:** [@Jose\_Gonzalez](https://forum.certara.com/u/Jose_Gonzalez)\
**Replies:** 0\
**Last updated:** [June 1, 2026, 9:54am UTC](https://forum.certara.com/t/p21-community-define-spec-generation-assigns-ae-aestdtc-as-text-instead-of-partialdatetime/4401 "2026-06-01T09:54:35Z")

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Hello all, When generating SDTM Define-XML specs from XPT files in P21 Community, we noticed that AE.AESTDTC was generated as partialDateTime in a previous study, but as text in a current study, which triggers a P21 fin…

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## [P21 validation gap: incorrect NCI Term Code not flagged](https://forum.certara.com/t/p21-validation-gap-incorrect-nci-term-code-not-flagged/4398)

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**Author:** [@Jose\_Gonzalez](https://forum.certara.com/u/Jose_Gonzalez)\
**Replies:** 1\
**Last updated:** [May 29, 2026, 10:36pm UTC](https://forum.certara.com/t/p21-validation-gap-incorrect-nci-term-code-not-flagged/4398 "2026-05-29T22:36:07Z")

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Hello all, Hello Team, as you can see p21 report is trigger the missing NCI codelist code of Completion Status as I was expected checking the DD0031 issue. But I am wondering why p21 report don’t trigger the wrong code…

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## [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)

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**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")

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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…

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## [2026-03-30 SEND CT in p21c](https://forum.certara.com/t/2026-03-30-send-ct-in-p21c/4386)

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**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")

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Hello! When can we expect 2026-03-30 SEND CT to become available in p21c? Thanks!

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## [DD0113 Error in P21 for the SDTM Define](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369)

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**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")

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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…

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## [About future ECLI](https://forum.certara.com/t/about-future-ecli/4390)

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**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")

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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, …

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## [Access Issue with Pinnacle21 Community via Proxy Network](https://forum.certara.com/t/access-issue-with-pinnacle21-community-via-proxy-network/4395)

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**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")

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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…

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## [New SDTM CT Version](https://forum.certara.com/t/new-sdtm-ct-version/4361)

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**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")

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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

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## [NLME error population PK model](https://forum.certara.com/t/nlme-error-population-pk-model/4383)

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**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")

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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…

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