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yh202109 committed Jul 16, 2024
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statlab_corr_tau.rst
statlab_corr_spearman_rho.rst
std_iso_pdf.ipynb
std_iso_idmp.ipynb
std_cdisc.ipynb
example_cdtg.ipynb
example_files.ipynb
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94 changes: 94 additions & 0 deletions docs/std_iso_idmp.ipynb
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{
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"<!-- \n",
" # Copyright (C) 2023-2024 Y Hsu <[email protected]>\n",
" #\n",
" # This program is free software: you can redistribute it and/or modify\n",
" # it under the terms of the GNU General Public license as published by\n",
" # the Free software Foundation, either version 3 of the License, or\n",
" # any later version.\n",
" #\n",
" # This program is distributed in the hope that it will be useful,\n",
" # but WITHOUT ANY WARRANTY; without even the implied warranty of\n",
" # MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE. See the\n",
" # GNU General Public License for more details\n",
" #\n",
" # You should have received a copy of the GNU General Public license\n",
" # along with this program. If not, see <https://www.gnu.org/license/> \n",
"-->"
]
},
{
"cell_type": "markdown",
"metadata": {},
"source": [
"# St/ISO/(IDMP)\n",
"\n",
"IDMP stands for Identification of Medicinal Products which consists five identification standards developed \n",
"within the International Organization for Standardization (ISO)[^1] \n",
"and utilized by FDA[^2] and required by EMA (mandated by the EU legislation, 2012) [^3]<sup>,</sup>[^4]. \n",
"\n",
"\n",
"ISO IDMP includes five standards:\n",
" \n",
"- ISO 11615 / ISO TS20443 / Medicinal Product Identification (MPID) \n",
"- ISO 11616 / ISO TS20451 / Pharmaceutical Product Identifier (PhPID)\n",
"- ISO 11238 / ISO TS19844 / Substance Identification (SubID)\n",
"- ISO 11239 / ISO TS20440 / Dosage Form and Route of Administration\n",
"- ISO 11240 / Units of Measurement (UoM)\n",
"\n",
"The two ISO numbers above are the main standard and technical specification guide. \n",
"Note that the exchange of IDMP messages based on HL7 message specifications.\n"
]
},
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"## MPID"
]
},
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"## Reference\n",
"\n",
"[^1]: ISO. (2017). Revised IDMP standards to improve description of medicinal products worldwide. ([web page](https://www.iso.org/news/ref2234.html))\n",
"[^2]: FDA. (year). Identification of Medicinal Products (IDMP). ([web page](https://www.fda.gov/industry/fda-data-standards-advisory-board/identification-medicinal-products-idmp))\n",
"[^3]: EMA. (year). Data on medicines (ISO IDMP standards): Overview. ([web page](https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview))\n",
"[^4]: EMA. (2016). Introduction to ISO Identification of Medicinal Products, SPOR programme. ([pdf](https://www.ema.europa.eu/en/documents/other/introduction-iso-identification-medicinal-products-spor-programme_en.pdf))\n",
"[^5]: EMA. (year). SPOR. ([web page](https://spor.ema.europa.eu/sporwi/))\n",
"\n",
"\n",
"\n",
"\n"
]
}
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