{"id":24195,"date":"2024-12-19T09:09:05","date_gmt":"2024-12-19T00:09:05","guid":{"rendered":"https:\/\/www.nbr.co.jp\/?page_id=24195"},"modified":"2024-12-19T14:07:20","modified_gmt":"2024-12-19T05:07:20","slug":"safetystudies-en","status":"publish","type":"page","link":"https:\/\/www.nbr.co.jp\/en\/safetystudies-en\/","title":{"rendered":"Safety Studies"},"content":{"rendered":"<style>\nth:nth-child(1) {\n  width:50%;\n}\ntable td {\n  vertical-align:top;\n}\n<\/style>\n<h2>Safety Studies (Pharmaceuticals)<\/h2>\n<h3>Single dose toxicity studies<\/h3>\n<table>\n<tbody>\n<tr>\n<th>Test<\/th>\n<th>Route of administration<\/th>\n<\/tr>\n<tr>\n<td>Single dose toxicity study<\/td>\n<td>Oral<br \/>Percutaneous<br \/>Intravenous<br \/>Subcutaneous<br \/>Intramuscular<br \/>Intraperitoneal<br \/>Intrarectal<br \/>Oral mucosal<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Repeated dose toxicity studies<\/h3>\n<table>\n<tbody>\n<tr>\n<th>Test<\/th>\n<th>Route of administration<\/th>\n<\/tr>\n<tr>\n<td>Repeated dose toxicity study<\/td>\n<td>Oral<br \/>Percutaneous<br \/>Intravenous<br \/>Subcutaneous<br \/>Intramuscular<br \/>Intraperitoneal<br \/>Intrarectal<br \/>Oral mucosal<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Reproductive and developmental toxicity studies<\/h3>\n<table>\n<tbody>\n<tr>\n<th>Test<\/th>\n<th>Route of administration<\/th>\n<\/tr>\n<tr>\n<td>FEED study<\/td>\n<td rowspan=\"3\">Oral<br \/>Transdermal<br \/>Intravenous<br \/>Subcutaneous<br \/>Intramuscular<br \/>Intraperitoneal<br \/>Intrarectal<br \/>Oral mucosal<\/td>\n<\/tr>\n<tr>\n<td>PPND study<\/td>\n<\/tr>\n<tr>\n<td>EFD study<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Local irritation tests<\/h3>\n<table>\n<tbody>\n<tr>\n<th>Test<\/th>\n<\/tr>\n<tr>\n<td>Primary skin irritation test<\/td>\n<\/tr>\n<tr>\n<td>Eye irritation test<\/td>\n<\/tr>\n<tr>\n<td>Cumulative skin irritation test<\/td>\n<\/tr>\n<tr>\n<td>Vascular irritation test<\/td>\n<\/tr>\n<tr>\n<td>Perivascular irritation test<\/td>\n<\/tr>\n<tr>\n<td>Hemolysis test<\/td>\n<\/tr>\n<tr>\n<td>Muscle irritation test<\/td>\n<\/tr>\n<tr>\n<td>Subcutaneous irritation test<\/td>\n<\/tr>\n<tr>\n<td>Rectal mucosal irritation test<\/td>\n<\/tr>\n<tr>\n<td>Vaginal mucosal irritation test<\/td>\n<\/tr>\n<tr>\n<td>Skin phototoxicity test<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Antigenicity tests<\/h3>\n<table>\n<tbody>\n<tr>\n<th>Test<\/th>\n<th>Method<\/th>\n<\/tr>\n<tr>\n<td>Skin sensitization test<\/td>\n<td>Adjuvant and Patch test<br \/>Maximization test<br \/>Buehler test<\/td>\n<\/tr>\n<tr>\n<td>Skin photosensitization test<\/td>\n<td>Adjuvant and Strip test<br \/>Harbor Test<\/td>\n<\/tr>\n<tr>\n<td>Antigenicity test<\/td>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Safety Studies (Medical Devices)<\/h2>\n<table>\n<tbody>\n<tr>\n<th colspan=\"2\">Test<\/th>\n<tr>\n<td>\n<h3>Cytotoxicity tests<\/h3>\n<p>Colony formation method<br \/>Elution test<\/td>\n<td>\n<h3>Skin sensitization tests<\/h3>\n<p>Maximization Test<br \/>Adjuvant and Patch Test<\/td>\n<\/tr>\n<tr>\n<td>\n<h3>Skin irritation test<\/h3>\n<p>Intradermal reaction test<br \/>Eye irritation test<br \/>LabCyte EPI-MODEL 24 SIT<\/td>\n<td>\n<h3>General toxicity tests<\/h3>\n<p>Acute systemic toxicity test<br \/>Subacute toxicity test<br \/>Subchronic toxicity test<br \/>Chronic toxicity test<\/td>\n<\/tr>\n<tr>\n<td>\n<h3>Genotoxicity tests<\/h3>\n<p>Reverse mutation test (Ames test)<br \/>Chromosomal aberration test<br \/>Micronucleus test (<i>in vitro<\/i>)<br \/>Micronucleus test (<i>in vivo<\/i>)<\/td>\n<td>\n<h3>Hemocompatibility tests<\/h3>\n<p>Hemolysis test<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Implantation tests<\/h3>\n<table>\n<tbody>\n<tr>\n<th>Test<\/th>\n<th>Implantation period<\/th>\n<tr>\n<td>Short-term intramuscular implantation<\/td>\n<td>1 week<br \/>4 weeks<\/td>\n<\/tr>\n<tr>\n<td>Implantation in bone<br \/>Implantation in organ<\/td>\n<td>4 weeks<br \/>13 weeks<br \/>26 weeks<br \/>39 weeks<br \/>52 weeks<br \/>104 weeks<\/td>\n<\/tr>\n<tr>\n<td>Stent implantation<\/td>\n<td>4 weeks<br \/>13 weeks<br \/>26 weeks<br \/>39 weeks<br \/>52 weeks<\/td>\n<\/tr>\n<tr>\n<td>Stent implantation<\/td>\n<td>1 weeks<br \/>4 weeks<br \/>13 weeks<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Others<\/h3>\n<table>\n<tbody>\n<tr>\n<th>Test<\/th>\n<th>Others<\/th>\n<tr>\n<td>Use simulation test<\/td>\n<td>Use simulation \/ chronic toxicity combination test<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Safety Studies (Regenerative Medical Products)<\/h2>\n<table>\n<tbody>\n<tr>\n<th colspan=\"2\">Test<\/th>\n<tr>\n<td>\n<h3>General toxicity tests<\/h3>\n<p>General toxicity test<\/td>\n<td>\n<h3>Safety pharmacology studies<\/h3>\n<p>Effects on clinical signs and behavior<br \/>Effects on the cardiovascular system<br \/>Effects on respiratory function<\/td>\n<\/tr>\n<tr>\n<td>\n<h3>Tumorigenicity tests<\/h3>\n<p>Tumorigenicity test (<i>in vivo<\/i>)<\/td>\n<td>\n<h3>Soft agar colony formation tests<\/h3>\n<p>Soft agar colony formation test (<i>in vitro<\/i>)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Safety Studies (Pharmaceuticals) Single dose toxicity studies Test Route of administration Single dose toxicit [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":18428,"parent":0,"menu_order":108,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_locale":"en_US","_original_post":"https:\/\/www.nbr.co.jp\/?page_id=24193","footnotes":""},"class_list":["post-24195","page","type-page","status-publish","has-post-thumbnail","hentry","en-US"],"_links":{"self":[{"href":"https:\/\/www.nbr.co.jp\/wp-json\/wp\/v2\/pages\/24195","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.nbr.co.jp\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.nbr.co.jp\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.nbr.co.jp\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nbr.co.jp\/wp-json\/wp\/v2\/comments?post=24195"}],"version-history":[{"count":3,"href":"https:\/\/www.nbr.co.jp\/wp-json\/wp\/v2\/pages\/24195\/revisions"}],"predecessor-version":[{"id":24198,"href":"https:\/\/www.nbr.co.jp\/wp-json\/wp\/v2\/pages\/24195\/revisions\/24198"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.nbr.co.jp\/wp-json\/wp\/v2\/media\/18428"}],"wp:attachment":[{"href":"https:\/\/www.nbr.co.jp\/wp-json\/wp\/v2\/media?parent=24195"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}