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Quarto GHA Workflow Runner committed Oct 1, 2024
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2 changes: 1 addition & 1 deletion .nojekyll
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"/posts/2024-03-04_inside_the__phar.../inside_the__pharmaverse.html",
"/posts/2024-03-01_rhino_shiny_app_validation/rhino_shiny_app_validation.html",
"/posts/2024-02-14_iscr_conference/iscr_conference.html",
"/posts/2024-03-01_admiral_filter_functions/admiral_filter_functions.html",
"/posts/2024-02-14_iscr_conference/iscr_conference.html",
"/posts/2024-02-13_teal_on_cran/teal_on_cran.html",
"/posts/2024-02-01_containers_webassembly_submission/containers_and_webassembly_submissions.html",
"/posts/2023-12-20_p_k__examples/p_k__examples.html",
"/posts/2023-12-18_admiral_1_0/admiral_1_0.html",
"/posts/2024-01-04_end_of__year__up.../end_of__year__update_from_the__pharmaverse__council.html",
"/posts/2023-12-18_admiral_1_0/admiral_1_0.html",
"/posts/2023-11-27_higher_order/higher_order.html",
"/posts/2023-10-30_floating_point/floating_point.html",
"/posts/2023-08-14_rhino_submission_2/rhino_submission_2.html",
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"/posts/2023-07-10_blanks_and_nas/blanks_and_nas.html",
"/posts/2023-07-09_falcon/falcon.html",
"/posts/2023-06-28_welcome/index.html",
"/posts/2023-06-27_admiral/valuelevel/derive_param_computed.html",
"/posts/2023-06-27_hackathon_writeup/index.html",
"/posts/2023-06-27__hackathon_app/index.html"
"/posts/2023-06-27__hackathon_app/index.html",
"/posts/2023-06-27_admiral/valuelevel/derive_param_computed.html"
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17 changes: 11 additions & 6 deletions posts/2023-06-27__hackathon_app/index.html
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<div class="cell-output cell-output-stdout">
<pre><code>Differences found between the objects!

A summary is given below.
Summary of BASE and COMPARE
==================================================================
PROPERTY BASE COMP
------------------------------------------------------------------
Name df1 df2
Class "tbl_df, tbl, data.frame" "tbl_df, tbl, data.frame"
Rows(#) 10 10
Columns(#) 2 2
------------------------------------------------------------------

Not all Values Compared Equal
All rows are shown in table below

Not all Values Compared Equal
=============================
Variable No of Differences
-----------------------------
letters 10
-----------------------------


All rows are shown in table below

========================================
VARIABLE ..ROWNUMBER.. BASE COMPARE
----------------------------------------
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:30:17.260128</p>
<p>2024-10-01 14:17:22.470134</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-06-27__hackathon_app/index.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:29:23.078162</p>
<p>2024-10-01 14:17:37.578043</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-06-27_admiral/valuelevel/derive_param_computed.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:30:03.745657</p>
<p>2024-10-01 14:16:53.45888</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-06-27_hackathon_writeup/index.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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2 changes: 1 addition & 1 deletion posts/2023-06-28_welcome/index.html
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:29:39.208297</p>
<p>2024-10-01 14:17:02.890245</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-06-28_welcome/index.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:29:33.183589</p>
<p>2024-10-01 14:18:03.825372</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-07-09_falcon/falcon.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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2 changes: 1 addition & 1 deletion posts/2023-07-10_blanks_and_nas/blanks_and_nas.html
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:30:15.352382</p>
<p>2024-10-01 14:18:11.070174</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-07-10_blanks_and_nas/blanks_and_nas.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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2 changes: 1 addition & 1 deletion posts/2023-07-14_code_sections/code_sections.html
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:29:24.949866</p>
<p>2024-10-01 14:17:07.095554</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-07-14_code_sections/code_sections.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:29:44.515709</p>
<p>2024-10-01 14:18:18.344284</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-07-20_cross_company_dev/cross_industry_dev.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:29:54.220065</p>
<p>2024-10-01 14:18:13.028342</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-07-24_rounding/rounding.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:29:27.09606</p>
<p>2024-10-01 14:17:26.510301</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-08-08_study_day/study_day.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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<!--------------- post begins here ----------------->
<p>There is significant momentum in driving the adoption of R packages in the life sciences industries, in particular, the R Consortium Submissions Working Group is dedicated to promoting the use of R for regulatory submissions to the FDA.</p>
<p>The <a href="https://rconsortium.github.io/submissions-wg/">R Consortium Submissions Working Group</a> successfully completed an R-based submission in November 2021 through the eCTD portal (R Submissions Pilot 1). This Pilot was completed on <a href="https://github.com/RConsortium/submissions-wg/blob/main/_Documents/Summary_R_Pilot_Submission2.pdf">March 10, 2022</a> after a successful statistical review and evaluation by the FDA staff.</p>
<p>Moving forward, the <a href="https://rconsortium.github.io/submissions-wg/pilot2.html">Pilot 2</a> aimed to include a Shiny application that the FDA staff could deploy on their own servers. The R Consortium recently announced that <a href="https://www.r-consortium.org/announcement/2023/10/05/shiny-app-successfully-reviewed-by-fda-cder-staff-pilot-2-announcement-2">on September 27, 2023</a>, the R Submissions Working Group successfully completed the follow-up to the Pilot 2 R Shiny-based submission and received a response letter from FDA CDER. This marks the first publicly available submission package that includes a Shiny component. The full FDA response letter can be found <a href="https://github.com/RConsortium/submissions-wg/blob/0f1dc5c30985d413f75d196c2b6caa96231b26ee/_Documents/Summary_R_Pilot2_Submission%2027SEP2023.pdf">here</a>.</p>
<p>Moving forward, the <a href="https://rconsortium.github.io/submissions-wg/pilot2.html">Pilot 2</a> aimed to include a Shiny application that the FDA staff could deploy on their own servers. The R Consortium recently announced that <a href="https://www.r-bloggers.com/2022/12/update-successful-r-based-package-submission-with-shiny-component-to-fda/">on September 27, 2023</a>, the R Submissions Working Group successfully completed the follow-up to the Pilot 2 R Shiny-based submission and received a response letter from FDA CDER. This marks the first publicly available submission package that includes a Shiny component. The full FDA response letter can be found <a href="https://github.com/RConsortium/submissions-wg/blob/0f1dc5c30985d413f75d196c2b6caa96231b26ee/_Documents/Summary_R_Pilot2_Submission%2027SEP2023.pdf">here</a>.</p>
<p>The Shiny application that was sent for the Pilot 2 had the goal to display the 4 Tables, Listings and Figures (TLFs) that were sent for the Pilot 1 with basic filtering functionality.&nbsp;</p>
<p>The submission package adhered to the eCTD folder structure and contained 5 deliverables. Among the deliverables was the proprietary R package {pilot2wrappers}, which enables the execution of the Shiny application.&nbsp;</p>
<p>The FDA staff were expected to receive the electronic submission packages in the eCTD format, install and load open-source R packages used as dependencies in the included Shiny application, reconstruct and load the submitted Shiny application, and communicate potential improvements in writing.&nbsp;</p>
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:29:03.768852</p>
<p>2024-10-01 14:17:49.151801</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-08-14_rhino_submission_2/rhino_submission_2.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:30:20.194896</p>
<p>2024-10-01 14:17:09.848045</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-09-26_date_functions_and_imputation/date_functions_and_imputation.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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<div id="quarto-appendix" class="default"><section id="last-updated" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Last updated</h2><div class="quarto-appendix-contents">

<p>2024-09-16 16:29:10.76446</p>
<p>2024-10-01 14:17:14.525997</p>
</div></section><section id="details" class="level2 appendix"><h2 class="anchored quarto-appendix-heading">Details</h2><div class="quarto-appendix-contents">

<p><a href="https://github.com/pharmaverse/blog/tree/main/posts/2023-10-10_pharmaverse_story/pharmaverse_story.qmd">Source</a>, <a href="https://pharmaverse.github.io/blog/session_info.html">Session info</a></p>
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