{"id":1021,"date":"2017-12-23T16:24:01","date_gmt":"2017-12-23T07:24:01","guid":{"rendered":"https:\/\/plaza.umin.ac.jp\/~OIO\/?page_id=1021"},"modified":"2024-04-27T16:27:57","modified_gmt":"2024-04-27T07:27:57","slug":"potential-signal-of-medical-products","status":"publish","type":"page","link":"https:\/\/plaza.umin.ac.jp\/~OIO\/?page_id=1021","title":{"rendered":"Safety Signal"},"content":{"rendered":"<h1>Potential Safety Signal of Medical Products<\/h1>\n<h2>\u306f\u3058\u3081\u306b<\/h2>\n<p>PMDA\u304c\u516c\u958b\u3057\u3066\u3044\u308b<a href=\"https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/adr-info\/suspected-adr\/0005.html\">\u533b\u85ac\u54c1\u526f\u4f5c\u7528\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9(JADER)<\/a>\u306e\u30c7\u30fc\u30bf\u3092\u3001WHO\u304c\u4f7f\u7528\u3059\u308bBCPNN\u3068\u8a00\u3046disproportionality\u3092\u691c\u51fa\u3059\u308b\u65b9\u6cd5\u3067\u96c6\u8a08\u3057\u305f\u7d50\u679c\u3067\u3059\u3002\u3069\u3046\u3084\u3063\u305f\u304b\u3068\u8a00\u3046\u306e\u306f<a href=\"https:\/\/wp.me\/p9b6zl-hb\">\u5225\u30da\u30fc\u30b8<\/a>\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002\u6700\u65b0\u306e\u30b9\u30af\u30ea\u30d7\u30c8\u306f\u672c\u30da\u30fc\u30b8\u306e\u4e0b\u306e\u65b9\u306b\u3042\u308a\u307e\u3059\u3002&lt;https:\/\/wp.me\/p9b6zl-hb&gt;<\/p>\n<p>\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3067\u304d\u306a\u3044\u5834\u5408\u306fCAPTCHA\u306e\u8a2d\u5b9a\u3092\u78ba\u8a8d\u3059\u308b\u304b\u3001\u5225\u306e\u30d6\u30e9\u30a6\u30b6\u3067\u304a\u8a66\u3057\u304f\u3060\u3055\u3044\u3002<\/p>\n<h2><a href=\"https:\/\/plaza.umin.ac.jp\/~OIO\/download\/bcpnn_202402\/\">\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/a><\/h2>\n<ul>\n<li>2024\u5e744\u6708\u516c\u958b\u306e\u30c7\u30fc\u30bf<div class='w3eden'><!-- WPDM Link Template: Default Template -->\n\n<div class=\"link-template-default card mb-2\">\n    <div class=\"card-body\">\n        <div class=\"media\">\n            <div class=\"mr-3 img-48\"><img decoding=\"async\" class=\"wpdm_icon\" alt=\"\u30a2\u30a4\u30b3\u30f3\"   src=\"https:\/\/plaza.umin.ac.jp\/~OIO\/wp-content\/plugins\/download-manager\/assets\/file-type-icons\/xlsx.png\" \/><\/div>\n            <div class=\"media-body\">\n                <h3 class=\"package-title\"><a href='https:\/\/plaza.umin.ac.jp\/~OIO\/?wpdmpro=bcpnn_202404'>BCPNN_202404<\/a><\/h3>\n                <div class=\"text-muted text-small\"><i class=\"fas fa-copy\"><\/i> 1 \u30d5\u30a1\u30a4\u30eb <i class=\"fas fa-hdd ml-3\"><\/i> 17.47 MB<\/div>\n            <\/div>\n            <div class=\"ml-3\">\n                <a href='#unlock' class='wpdm-download-link wpdm-download-locked btn btn-primary ' data-package='3501'>bcpnn202404<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<\/div>\uff082023\u5e7412\u6708\u307e\u3067\u306bPMDA\u304c\u53d7\u7406\u3057\u305f\u30c7\u30fc\u30bf\u304c\u542b\u307e\u308c\u307e\u3059\uff09<\/li>\n<\/ul>\n<h2>Terms and Conditions:<\/h2>\n<ul>\n<li>\u89e3\u6790\u3057\u305f\u30c7\u30fc\u30bf\u306f\u81ea\u767a\u5831\u544a\u306e\u30c7\u30fc\u30bf\u3092\u591a\u304f\u542b\u307f\u307e\u3059\u3002\u81ea\u767a\u5831\u544a\u306f\u85ac\u6a5f\u6cd5\uff08\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u54c1\u8cea\u3001\u6709\u52b9\u6027\u53ca\u3073\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\uff09\u306b\u57fa\u3065\u304d\u3001<a href=\"http:\/\/www.pmda.go.jp\/int-activities\/int-harmony\/ich\/0024.html\">ICH<\/a>\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u7b49\u3067\u898f\u5b9a\u3055\u308c\u305f\u8003\u3048\u65b9\u306b\u57fa\u3065\u3044\u3066\u4e00\u5b9a\u306e\u57fa\u6e96\u306b\u9069\u5408\u3059\u308b\u60c5\u5831\u304cPMDA\u306b\u5831\u544a\u3055\u308c\u307e\u3059\u3002\u30c7\u30fc\u30bf\u53ce\u96c6\u65b9\u6cd5\u306e\u7279\u6027\u4e0a\u3001\u30c7\u30fc\u30bf\u306e\u89e3\u91c8\u306f\u5358\u7d14\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3042\u308b\u533b\u85ac\u54c1\u306b\u4f55\u3089\u304b\u306e\u4e8b\u8c61\u3067disproportionality\u3092\u8a8d\u3081\u305f\u3068\u3057\u3066\u3082\u3001\u305d\u306e\u4e8b\u8c61\u304c\u305d\u306e\u533b\u85ac\u54c1\u306e\u30ea\u30b9\u30af\u3068\u5224\u65ad\u3067\u304d\u308b\u6839\u62e0\u306b\u306a\u308b\u3088\u3046\u306a\u6307\u6a19\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u901a\u5e38\u3001statistical disproportionaltiy\u306f\u3001signal \u306e\u53ef\u80fd\u6027\u304c\u3042\u308b\u306e\u3067\u3001\u8a73\u7d30\u306b\u8a55\u4fa1\u3092\u3059\u308b\u512a\u5148\u9806\u4f4d\u3092\u4e0a\u3052\u308b\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u7684\u306a\u76ee\u7684\u3067\u5229\u7528\u3055\u308c\u308b\u3082\u306e\u3067\u3059\u3002<\/li>\n<li>\u672c\u30c7\u30fc\u30bf\u3092\u5229\u7528\u3059\u308b\u306b\u5f53\u305f\u308a<a href=\"https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/adr-info\/suspected-adr\/0003.html\">PMDA\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u5229\u7528\u898f\u7d04<\/a>\u306b\u540c\u610f\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li>\u89e3\u6790\u306b\u306f\u4e07\u5168\u3092\u671f\u3057\u307e\u3059\u304c\u3001\u3053\u308c\u306f\u96c6\u8a08\u7d50\u679c\u304c\u5b8c\u5168\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002Observation Island\u306f\u3001\u672c\u30c7\u30fc\u30bf\u306e\u5229\u7528\u306b\u8d77\u56e0\u3059\u308b\u3044\u304b\u306a\u308b\u640d\u5bb3\u306b\u3064\u3044\u3066\u3082\u3001\u8ce0\u511f\u3059\u308b\u7fa9\u52d9\u3092\u4e00\u5207\u8ca0\u3044\u307e\u305b\u3093\u3002<\/li>\n<li>2018\u5e748\u6708\u3088\u308a\u30b7\u30b0\u30ca\u30eb\u5224\u5b9a\u306e\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u3092\u5909\u66f4\u3057\u3066\u3044\u307e\u3059\u3002\u4e3b\u306a\u5909\u66f4\u70b9\u306f\u3001\u305d\u308c\u4ee5\u524d\u306f\u300cPhViD\u30c7\u30d5\u30a9\u30eb\u30c8\u8a2d\u5b9a\u300d\u3067\u5224\u5b9a\u3057\u3066\u3044\u305f\u3082\u306e\u3092\u3001\u300cIC\u5024\u306e95%\u4fe1\u983c\u533a\u9593\u4e0b\u9650\u304c0\u3092\u8d85\u3048\u3066\u3001\u304b\u30643\u4ef6\u4ee5\u4e0a\u96c6\u7a4d\u300d\u3068\u3057\u307e\u3057\u305f\u3002\u5177\u4f53\u7684\u306b\u306f\u4ee5\u4e0b\u306e\u30b9\u30af\u30ea\u30d7\u30c8\u3092\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n<blockquote><p>##############################################<br \/>\n# Statistical Disproportionality Analysis Script using PhViD<br \/>\n#<br \/>\n# based on PMDA JADER 2017 SEP data harvouring data as of Apr 2018<br \/>\n#<br \/>\n# by Dr. Y.Oshima 2018.08.27<br \/>\n#<br \/>\n#<br \/>\n#############################################library (PhViD)<\/p>\n<p>setwd(&#8220;C:\/JADER\/&#8221;)<\/p>\n<p>JADER_Data &lt;- read.csv(&#8220;0040DataMatrix.csv&#8221;, header = TRUE)<br \/>\nDataBase &lt;- as.PhViD(JADER_Data, MARGIN.THRES = 1)<br \/>\nBCPNN &lt;- BCPNN(DataBase, MIN.n11 = 3, DECISION = 3, RANKSTAT = 2)<br \/>\nwarnings()<br \/>\nwrite.csv (BCPNN$SIGNALS, &#8220;BCPNN.csv&#8221;)<\/p>\n<p>############################################## Arguments<br \/>\n#<br \/>\n# DATABASE<br \/>\n# Object returned by the function as.PhViD.<br \/>\n#<br \/>\n# RR0<br \/>\n# Value of the tested risk. By default, RR0=1.<br \/>\n#<br \/>\n# MIN.n11<br \/>\n# Minimum number of notifications for a couple to be potentially considered as<br \/>\n# a signal. By default, MIN.n11 = 1.<br \/>\n#<br \/>\n# DECISION<br \/>\n# Decision rule for the signal generation based on<br \/>\n#<br \/>\n# 1 = FDR (Default value)<br \/>\n#<br \/>\n# 2 = Number of signals<br \/>\n#<br \/>\n# 3 = Ranking statistic. See RANKSTAT<br \/>\n#<br \/>\n# DECISION.THRES<br \/>\n# Threshold for DECISION. Ex 0.05 for FDR (DECISION=1).<br \/>\n#<br \/>\n# RANKSTAT<br \/>\n# Statistic used for ranking the couples:<br \/>\n#<br \/>\n# 1 = Posterior probability of the null hypothesis<br \/>\n#<br \/>\n# 2 = 2.5% quantile of the posterior distribution of IC.<br \/>\n#<br \/>\n# MC<br \/>\n# If MC=TRUE, the statistic of interest (see RANKSTAT) is calculated by Monte<br \/>\n# Carlo simulations which can be very long. If MC=FALSE, IC is approximated by<br \/>\n# a normal distribution (which can be very crude for small counts).<br \/>\n#<br \/>\n# NB.MC<br \/>\n# If MC=TRUE, NB.MC indicates the number of Monte Carlo simulations to be done<br \/>\n#<\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Potential Safety Signal of Medical Products \u306f\u3058\u3081\u306b PMDA\u304c\u516c\u958b\u3057\u3066\u3044\u308b\u533b\u85ac\u54c1\u526f\u4f5c\u7528\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9(JADER)\u306e\u30c7\u30fc\u30bf\u3092\u3001WHO\u304c\u4f7f\u7528\u3059\u308bBCPNN\u3068\u8a00\u3046dispropor&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1021","page","type-page","status-publish","hentry"],"jetpack_shortlink":"https:\/\/wp.me\/P9b6zl-gt","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/pages\/1021","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1021"}],"version-history":[{"count":1,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/pages\/1021\/revisions"}],"predecessor-version":[{"id":3503,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/pages\/1021\/revisions\/3503"}],"wp:attachment":[{"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1021"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}