Programming vaccine specific Clinical Data Interchange Standards Consortium (CDISC) compliant Analysis Data Model (ADaM) datasets in 'R'. Flat model is followed as per Center for Biologics Evaluation and Research (CBER) guidelines for creating vaccine specific domains. ADaM datasets are a mandatory part of any New Drug or Biologics License Application submitted to the United States Food and Drug Administration (FDA). Analysis derivations are implemented in accordance with the "Analysis Data Model Implementation Guide" (CDISC Analysis Data Model Team (2021), <https://www.cdisc.org/standards/foundational/adam/adamig-v1-3-release-package>). The package is an extension package of the 'admiral' package.
Package details |
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Author | Sukalpo Saha [aut, cre], Arjun Rubalingam [aut], Ben Straub [aut], Vikram S [aut], Dhivya Kanagaraj [aut], Federico Baratin [aut], Yamini Purna Bollu [aut], Ilse Augustyns [aut], Kalyani Bodicherla [aut], Hilde Delanghe [aut], Lee Armishaw [aut], Neetu Sangari [ctb], Abdul Khayat [ctb], Ankur Jindal [ctb], Jayashree V [ctb], Jagadish Katam [ctb], Andrea Pammolli [ctb], Daniele Bottigliengo [ctb], Ranya Ben Hsain [ctb], Marleen Nijs [ctb], Mandy Peng [ctb], Tina Zhai [ctb], Ross Farrugia [ctb], Stefan Bundfuss [ctb], Edoardo Mancini [ctb], Pfizer Inc. [cph, fnd], GlaxoSmithKline LLC [cph, fnd], Johnson & Johnson [cph, fnd] |
Maintainer | Sukalpo Saha <sukalpo.saha@pfizer.com> |
License | Apache License (>= 2) |
Version | 0.3.0 |
URL | https://pharmaverse.github.io/admiralvaccine/ https://github.com/pharmaverse/admiralvaccine/ |
Package repository | View on CRAN |
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