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日本代购-米国FDA医薬品・医療機器規制入門/藤巻伍【1000円以上送料無料】
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日本代购-著者藤巻伍(著)出版社商事法務発売日2024年09月ISBN9784785730802ページ数295Pキーワードべいこくえふでいーえーいやくひんいりようきききせい ベイコクエフデイーエーイヤクヒンイリヨウキキキセイ ふじまき ひとし フジマキ ヒトシ9784785730802内容紹介米国の医薬品・医療機器規制に関する入門書アメリカ食品医薬品局(FDA)による医薬品・医療機器規制について、筆者がアメリカでの留学・研修(製薬企業法務部、法律事務所(FDAプラクティスグループ))で得た知識・経験に基づき、図表を多く用いてわかりやすく解説。アメリカにおける医薬品及び医療機器に関する最新の法規制および制度を知るための入門書。また、読みごたえのある、有識者による11のコラム(Expert Insights)を含む、13のコラムも収録。※本データはこの商品が発売された時点の情報です。目次FDAの概要/医薬品とは/医薬品規制の基礎/IND申請及び臨床試験に関する規制/New Drug Application(NDA)から承認までのプロセス/試験薬(未承認薬)の使用(Expanded access program)/医薬品早期審査制度(Expedited programs)の活用/医薬品の市販後規制/OTC医薬品規制/ジェネリック医薬品規制とパテントリンケージ/特許権と独占権(Exclusivity)によるライフサイクルマネジメント/医療機器とは/医療機器のクラス分類/Investigational Device Exemption(IDE)規制/医療機器の販売認可/承認制度等と早期審査制度/医療機器の市販後規制/デジタルヘルス—ソフトウェアの医療機器該当性/デジタルヘルス—承認等審査の迅速化・簡素化等に向けた取組み/コンビネーション製品規制/医薬品・医療機器等の開発及び製造の現代化/表示・広告規制/その他のヘルスケアプロダクトの規制(バイオ医薬品、化粧品)、法令違反に対するFDAの執行権限/FDA inspection
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Process: 0.188s ( Load:0.011s Init:0.012s Exec:0.159s Template:0.006s ) | DB :22 queries 0 writes | Cache :5 gets 2 writes | UseMem:26,623 kb
页面Trace信息
当前页面 : /index.php/Rakuten/ShopView/id/bookfan:12972023.html
请求方法 : GET
通信协议 : HTTP/1.1
请求时间 : 2025-09-01 08:09:03
用户代理 : Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)
会话ID : rtu5ibgq7r5fqd9kfkvglq4n05
运行数据 : Process: 0.188s ( Load:0.011s Init:0.012s Exec:0.159s Template:0.006s ) | DB :22 queries 0 writes | Cache :5 gets 2 writes | UseMem:26,623 kb
输出编码 :
加载类库 : 33
模板编译 : 重新编译
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[ 25-09-01 08:09:03 ] RunTime:0.000729s SQL = SHOW COLUMNS FROM bio_agent
[ 25-09-01 08:09:03 ] RunTime:0.000286s SQL = SELECT * FROM bio_agent WHERE ( `isViews` = 1 ) AND ( `domain` LIKE '%test.ripai.com' )
[ 25-09-01 08:09:03 ] RunTime:0.000203s SQL = SELECT * FROM bio_agent WHERE ( `domain` = 'www.jp-daigou.com' )
[ 25-09-01 08:09:03 ] RunTime:0.000259s SQL = select * from bio_siteparams where FIND_IN_SET('081',AgentID)
[ 25-09-01 08:09:03 ] RunTime:0.000288s SQL = SHOW COLUMNS FROM bio_point
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[ 25-09-01 08:09:03 ] RunTime:0.000346s SQL = SHOW COLUMNS FROM bio_syscolumn
[ 25-09-01 08:09:03 ] RunTime:0.000237s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = 17 ) AND ( `column_open` = 1 ) ORDER BY column_order asc
[ 25-09-01 08:09:03 ] RunTime:0.000326s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = '19' ) AND ( `column_open` = 1 ) ORDER BY column_order asc
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[ 25-09-01 08:09:03 ] RunTime:0.000291s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = '20' ) AND ( `column_open` = 1 ) ORDER BY column_order asc
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[ 25-09-01 08:09:03 ] RunTime:0.000201s SQL = SELECT p.id,p.name_cn FROM bio_rakutencategory p LEFT JOIN bio_rakutencategory c on c.parentid=p.id WHERE c.id=101278
[ 25-09-01 08:09:03 ] RunTime:0.000163s SQL = SELECT p.id,p.name_cn FROM bio_rakutencategory p LEFT JOIN bio_rakutencategory c on c.parentid=p.id WHERE c.id=200162
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[ 25-09-01 08:09:03 ] 注意:[8] A session had already been started - ignoring session_start() App.class.php 第 115 行.
[ 25-09-01 08:09:03 ] 注意:[8192] Assigning the return value of new by reference is deprecated apiExecuter.php 第 253 行.
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[ 25-09-01 08:09:03 ] 注意:[8192] Assigning the return value of new by reference is deprecated Client.php 第 179 行.
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[ 25-09-01 08:09:03 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
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[ 25-09-01 08:09:03 ] 注意:[8] Undefined variable: agentId common_inc.php 第 3135 行.
[ 25-09-01 08:09:03 ] 注意:[8] Undefined index: isDebugMe forbidcates.php 第 108 行.
[ 25-09-01 08:09:03 ] 注意:[2] shuffle() expects parameter 1 to be array, boolean given BaseAction.class.php 第 418 行.
[ 25-09-01 08:09:03 ] 注意:[8] Undefined property: RakutenApiExecuter::$ApiDataWorker RakutenApiExecuter.php 第 346 行.
[ 25-09-01 08:09:03 ] 注意:[8] Undefined index: appid getApiData.php 第 417 行.
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[ 25-09-01 08:09:03 ] 注意:[8] Undefined variable: options Unserializer.php 第 448 行.
[ 25-09-01 08:09:03 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 503 行.
[ 25-09-01 08:09:03 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 509 行.
[ 25-09-01 08:09:03 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context RakutenAction.class.php 第 595 行.
[ 25-09-01 08:09:03 ] 注意:[8] Undefined index: isDebugMe RakutenAction.class.php 第 607 行.
[ 25-09-01 08:09:03 ] 注意:[8] Undefined index: categoryPath RakutenCategoryGetter.class.php 第 55 行.
[ 25-09-01 08:09:03 ] 注意:[8] Undefined index: _imgserver YahooAction.class.php 第 1014 行.
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[ 25-09-01 08:09:03 ] 注意:[8] Undefined index: descpre RakutenAction.class.php 第 645 行.
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[ 25-09-01 08:09:03 ] 注意:[8] Undefined variable: agentId common_inc.php 第 3135 行.
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[ 25-09-01 08:09:03 ] 注意:[8] Undefined variable: meta_keyword 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 7 行.
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[ 25-09-01 08:09:03 ] 注意:[8] Undefined variable: shopcode 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 296 行.
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