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Pharm Stat-DM news: 2月 2011
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Regulatory information links on new drug development ; study designing, planning and statistics. 火曜日, 2月 01, 0023. 20100928 FDA 21CFR part312 IND Safety Reporting Requirements. Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans. Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies (Draft) (PDF - 688KB).
Pharm Stat-DM news: 20100928 FDA Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies
http://ph-statdm-news.blogspot.com/2011/02/20100928-fda-safety-reporting.html
Regulatory information links on new drug development ; study designing, planning and statistics. 火曜日, 2月 01, 0023. 20100928 FDA Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies. 20100928 FDA 21CFR part312 IND Safety Reporting Re. 20100928 FDA Safety Reporting Requirements for IND. EMEA Inspection What's New. FDA CBER What's New. FDA CDER What's New. Folding@home aki-homework team rank. Http:/ www.amazon.co.jp/.
Pharm Stat-DM news: 7月 2010
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Regulatory information links on new drug development ; study designing, planning and statistics. 金曜日, 7月 09, 0022. 20100709 MHLW 『経口血糖降下薬の臨床評価法に関するガイドライン（案）』 パブリックコメント結果. 12300;『経口血糖降下薬の臨床評価法に関するガイドライン（案）』 に関する意見の募集について」に対して寄せられたご意見等について. Http:/ search.e-gov.go.jp/servlet/Public? 12300;経口血糖降下薬の臨床評価法に関するガイドライン（案）」 に関する意見の募集について. Http:/ search.e-gov.go.jp/servlet/Public? 20100709 MHLW 『経口血糖降下薬の臨床評価法に関するガイドライン（案）』 パブリックコメ. EMEA Inspection What's New. FDA CBER What's New. FDA CDER What's New.
Pharm Stat-DM news: 5月 2010
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Regulatory information links on new drug development ; study designing, planning and statistics. 金曜日, 5月 28, 0022. 20100520 EMA Guideline on the treatment of Premenstrual Dysphoric Disorder (PMDD) Draft. 20100520 EMA Guideline on the treatment of Premenstrual Dysphoric Disorder (PMDD) Draft. Http:/ www.ema.europa.eu/pdfs/human/ewp/60702209en.pdf. 木曜日, 5月 06, 0022. 20100428 MHLW 薬害肝炎検証・検討委員会「最終提言」. 薬害肝炎検証・検討委員会「最終提言」について. Http:/ www.mhlw.go.jp/shingi/2010/04/s0428-8.html. EMEA Inspection What's New.
Pharm Stat-DM news: 20110216 FDA guidance DRAFT: Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets
http://ph-statdm-news.blogspot.com/2011/04/20110216-fda-guidance-draft.html
Regulatory information links on new drug development ; study designing, planning and statistics. 金曜日, 4月 08, 0023. 20110216 FDA guidance DRAFT: Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets. Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (PDF - 316KB). Http:/ www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243537.pdf. 20110217 FDA guidance DRAFT: Clinical Pharmacogeno.
Pharm Stat-DM news: 20110331 FDA guidance: Postmarketing Studies and Clinical Trials
http://ph-statdm-news.blogspot.com/2011/04/20110331-fda-guidance-postmarketing.html
Regulatory information links on new drug development ; study designing, planning and statistics. 金曜日, 4月 08, 0023. 20110331 FDA guidance: Postmarketing Studies and Clinical Trials. Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act (PDF - 276KB). Http:/ www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf. 20110217 FDA guidance DRAFT: Clinical Pharmacogeno. EMEA Inspection What's New.
Pharm Stat-DM news: 8月 2010
http://ph-statdm-news.blogspot.com/2010_08_01_archive.html
Regulatory information links on new drug development ; study designing, planning and statistics. 月曜日, 8月 09, 0022. 20100809 MHLW 「電子化された医療情報データベースの活用による医薬品等の安全・安心に関する提言（案）（日本のセンチネル・プロジェクト）」. 12300;電子化された医療情報データベースの活用による医薬品等の安全・安心に関する提言（案）（日本のセンチネル・プロジェクト）」に関する意見募集の実施について. 結果の公示日 2010年08月09日 意見公募時の案の公示日 2010年06月22日. Http:/ search.e-gov.go.jp/servlet/Public? 12300;電子化された医療情報データベースの活用による医薬品等の安全・安心に関する提言（案）（日本のセンチネル・プロジェクト）」に関する意見募集の実施について. Http:/ search.e-gov.go.jp/servlet/Public? EMEA Inspection What's New.
Pharm Stat-DM news: 1月 2011
http://ph-statdm-news.blogspot.com/2011_01_01_archive.html
Regulatory information links on new drug development ; study designing, planning and statistics. 水曜日, 1月 19, 0023. 新医薬品の総審査期間短縮に向けた申請に係るCTDのフォーマットについて（平成23年１月17日 事務連絡）(PDF,236KB)【医薬食品局審査管理課 薬事法関係】. Http:/ wwwhourei.mhlw.go.jp/hourei/doc/tsuchi/T110119I0010.pdf. 金曜日, 1月 14, 0023. 20110106 FDA draft guidance "Electronic Source Documentation in Clinical Investigations". Electronic Source Documentation in Clinical Investigations. III ELECTRONIC SOURCE DOCUMENTS AND SOURCE DATA. A Tier 1 - Data Entry.
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