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NEWS.md

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aNCA (development version)

Features added

  • Searchable PK parameter reference table added to NCA > Setup, showing metadata, app location, and PKNCA function for each parameter (#1023)
  • Settings YAML units can now contain just PPTESTCD and PPSTRESU (default target units). (#1027)
  • Exploration plots: toggle legend visibility, improved tooltips with color-by variable, and correct axis/legend labels (#988)
  • Exploration plots: "Add to Exports" button saves named plot snapshots to the ZIP export. When custom snapshots exist for a plot type, only the snapshots are exported (the default plot is omitted). QC plot also included in the export tree (#1002)
  • CDISC ZIP export now includes a Pre_Specs.xlsx file with variable-level metadata for each selected dataset (#998)
  • New "About" tab in the app sidebar with links, citation, authors, license, version info, and a "Copy session info" button (#1015)
  • Export filenames use STUDYID as fallback when no project name is set, date suffix removed (#1000)
  • Project name auto-populated from STUDYID on data upload (#1000)
  • Enhancements to the slides outputs including grouping by PKNCA groups, dose profile, and additional grouping variables (#791)
  • Option to include and apply NCA flag rules with reasons (NCAwXRS) as defined by ADNCA standards. Any record populated within these columns will be excluded for the NCA (#752)
  • R script exported in ZIP folder to re-run and replicate App outputs (#789)
  • Individual and Mean plots tabs now created using the same function, so the layout and plot themes are consistent across both plots (#712)
  • New flagging rule for lambda-z calculations based on r-squared, R2 (#834)
  • New Parameter Selection section in NCA tab allowing to select parameters by study type (#795)
  • The App optionally maps end of sample collection (AEFRLT) for excretion rate parameter calculations: ERTLST, ERTMAX. (#745)
  • Option to upload multiple input files, which will be bound together to form a single ADNCA data set (#821)
  • BLQ imputation rules can be applied to the NCA via NCA Setup > Data Imputation (#139)
  • Section General Exclusions allowing to perform in-App NCA exclusions (#851)
  • Mean plots have been added in the TLGs section, with BLQ handling (#555)
  • CMAX automatically selected in box plots if available (#890)
  • Allow user to select additional grouping variables (chosen in the mapping) for ratio calculations (#868)
  • General button at top page to save all NCA results, settings & draft slides as a ZIP file (#638)
  • Settings are now uploaded on initial opening of the app in the data tab, and applied to the next steps (#860)
  • Settings file has been converted from rds to yaml, allowing better readability and editing for users. (#901)
  • WTBL and WTBLU columns added to the data mapping, for optional conversion of dose to adjust to body weight for excretion calculations (#959)
  • Slope selector table for half life adjustments uses time to choose the point of interest. Also it is aesthetics have been polished (#956)
  • Partial interval parameters section now allows other calculations than AUCINT, such as RCAMINT, AUCINTD or CAVGINT among others (#524)
  • Slope selector plots count with grouping options (#333)
  • Add x/y axis limits for the exploration plots (#817) and facet titles including subject count (#894)
  • Settings upload and processing is flexible, so non-data specific template settings can be uploaded (#993)
  • Help buttons have been included/updated for most App sections: Parameter Selection, Slope Selector, Additional Analysis and Partial Interval calculations (#975)
  • Export modal now allows users to select which slide sections (mean plots, statistics, line plots, box plots, individual plots/parameters, additional analysis) to include in PPTX and HTML exports; box plot parameters are also configurable (#972)

Bugs fixed

  • ZIP folder with results will now include the exploration tab outputs: individual plots, mean plots (#794)
  • Updated TMAX label from Time of CMAX to Time of CMAX Observation (#787)
  • Bug fix for box/violin plots that were crashing when violin option selected (#786)
  • Summary statistic table changes in grouping variables won't remove previous summary settings (#840)
  • No longer offering direct PK calculations for renal clearance (RENALCL) parameters. PKNCA is currently inaccurate. Instead, the ratios table should be used (#781)
  • No longer offering PK calculations for PKNCA multidose parameters; mean residence time (MRTMDO, MRTMDP), steady state volume of distribution (VSSMDP, VSSMDO) and time above (TAT). They are not really able to be calculated using PKNCA (#869)
  • Bug fix for settings upload via zip file output (#832)
  • Bug fix for plotting section where if there is >1 unit the axis label will contain both unique units. (#818)
  • Units table bugs fixed, so it is filtered based on NCA setup and the table is searchable for each column (#870)
  • Bug fix to allow for unrecognized units to be used in AVALU and DOSEU (#861)
  • Bug fix so NA units are allowed in the data (as per CDISC guidelines for NA samples) and not treated as a unique unit (#907)
  • Bug fix so app doesn't crash if NCA is rerun with an error (e.g. No exclusion REASON) (#913)
  • NCA results flagging logic updated to include Missing column and correctly identify difference between missing and not requested (#934)
  • Pagination controls in the slope selector and the interactivity of the plots is less buggy (#956)
  • Creation of intervals reworked to prevent doses being combined if no samples are taken post dose (#963)
  • Parameter selection no longer resets after changes to NCA setup and slope selector- apart from changes to analyte and pcspec that change the study types detected (#1008)

aNCA 0.1.0

  • Initial CRAN submission.