製薬企業統
計担当者のためのICHガイドライン集
Since 18 Nov 2001
(New site: since 3 Aug 2003)
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>
- E1 The Extent
of Population Exposure to Assess
Clinical Safety
- E2A Clinical
Safety Data Management:
Definitions and Standards for Expedited Reporting
- E3 Structure
and Content of Clinical Study
Report
- E4
Dose-Response Information to Support Drug
Registration
- E5 Ethnic
Difference
(MHW Iyakushin no.672, 11 Aug. 1998)
- E6 ICH GCP
- E7 Studies in
Support of Special Populations:
Geriatrics
- E8 General
Considerations for Clinical Trials
- E9 Statistical
Principle (MHW Iyakushin
no.1047, 30 Nov. 1998)
- E10 Choice of
control group (MHW
Iyakushin no.136, 27 Feb. 2000)
- M4 CTD (Japanese
Only)
- CTD related links (PMDA)
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- European guidances
- CPMP/EWP/2158/99 Guideline
on the Choise of the Non-Inferiority Margin (Adopted by
Committee July 2005)
- CPMP/EWP/2158/99
Points to Consider on Non-Inferiority Margin
(Released for consultation February 2004)
- CPMP/EWP/482/99
Points to Consider on Switching between Superiority and
Non-inferiority (Adopted July 2000)
- CPMP/EWP/2863/99
Points to Consider on Adjustment for baseline Covariates
(CPMP adopted May 2003)
- CPMP/EWP/908/99
CPMP Points to Consider on Multiplicity issues in
Clinical Trials (CPMP Adopted September 2002)
- CPMP/EWP/1776/99
Points to Consider on Missing Data ( Adopted
November 2001)
- CPMP/2330/99
Points to Consider on Application with 1.) Meta-analyses
and
2.) One Pivotal study (adopted by CPMP May 2001)
- CPMP/EWP/QWP/1401/98
Note For Guidance on the Investigation of Bioavailability and
Bioequivalence (Adopted July 2001)
- CHMP/EWP/2459/02 Reflection Paper
on Methodological Issues in Confirmatory Clinical Trials with Flexible
design and Analysis Plan (adoption by CHMP 18 October
2007)
- CHMP/EWP/83561/05
Guideline on Clinical Trials in Small Populations (Adopted by CHMP July
2006) Q&A
-
- US guidances
- Statistical Approaches to Establishing
Bioequivalence
(Issued 2/2001, Posted 2/1/2001) 3616fnl.pdf
- In Vivo Drug Metabolism/Drug Interaction
Studies -
Study Design, Data Analysis, and Recommendations for Dosing and
Labeling 2635fnl.pdf
(Issued 11/24/1999, Posted 11/24/1999)
- Pharmacokinetics in Patients with Impaired
Hepatic
Function: Study Design, Data Analysis, and Impact on Dosing
and
Labeling 3625fnl.pdf
(Posted 5/30/2003)
- Pharmacokinetics in Patients with Impaired
Renal Function 1449fnl.pdf (Issued
5/14/1998, Posted 5/14/1998)
- Population Pharmacokinetics 1852fnl.pdf
(Issued 2/1999, Posted 2/10/1999)
- Providing Clinical Evidence of Effectiveness for
Human Drug and Biological Products 1397fnl.pdf (Issued 5/14/1998,
Posted 5/14/1998)
- Study and Evaluation of Gender Differences
in the
Clinical Evaluation of Drugs old036fnl.pdf
(Issued 7/22/1993, Posted 3/2/1998)
- Exposure-Response Relationships -
Study Design, Data
Analysis, and Regulatory Applications [Word: 5341fnl.doc]
or [PDF: 5341fnl.pdf]
(Posted 5/5/2003)
Electronic
Clinical Trial Link updated!
- PhRMA "Electronic Clinical Data Capture Position Paper
Revision 1" (2005/05/01)
eclinicalforumサイトのReports, Presentations, Articles and Publications=>見付かりません
- PhRMA "The
Future Vision of Electronic Health Records as eSource for Clinical
Research" Version 1.0 (2006/9/14)
eclinicalforumサイトのファイル=>見付かりません Draft
- EMEA "Reflection Paper on Expectations for Electronic
Source Documentsused in Clinical Trials" (Draft 2007/10/17)
- CDISC eSDI group "Leveraging the CDISC Standards to Facilitate the use of Electronic Source Data within Clinical Trials"
(v1.0 2006/11/20)
CDISC eSource Data Interchange Document
- FDA "Guidance for Industry: Computerized Systems Used
in Clinical Investigations" (2007/05)
- FDA "Guidance for Industry on Part 11, Electronic
Records; ElectronicSignatures--Scope and Application"
(2003/08)
- FDA "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (2002/01/11)
- 「医薬品等の承認又は許可等に係る申請等における電磁的記録及び電子署名の利用について」(薬食
発第0401022号2005/04/01)
パブリックコメン
ト結果
- 医療情報システムの安全管理に関するガイドライン第4.1版(2010/02)
http://www.mhlw.go.jp/shingi/2010/02/s0202-4.html
- EU "GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN
REGULATED “GXP”ENVIRONMENTS" (PIC/S Guidance PI 011-3
2007/09/25)
http://www.picscheme.org/publication.php?id=8
- EU PIC/S GMP GUIDE (ANNEXES) ANNEX 11:COMPUTERISED
SYSTEMS (PI 009-9 2009/09/01)
http://www.picscheme.org/publication.php?id=4
- SCDM "Good Clinical Data Management Practices" (GCDMP)
(Japanese translation is available!)
https://www.scdm.org/gcdmp/
<= Membership or fee required to download New! 日本語版購入リンク
- 製薬協EDC自主ガイダンスおよび説明会資料
http://www.jpma.or.jp/about/basis/guide/clinical.html
Anticancer drug
development related links
NCI
- Response Evaluation Criteria in Solid Tumors
(RECIST)
固形がんの治療効果判定のための新ガイドライン(RECIST
ガイドライン)―日本語訳JCOG版―
- CTC v2.0 and Common Terminology Criteria for
Adverse Events v3.0 (CTCAE)
NCI-CTC 日本語訳本文 インデックス (JCOG)
CTCAEv3.0日本語訳JCOG/JSCO版
Japan
- 抗悪性腫瘍薬の臨床評価方法に関するガイドライン 改訂版(2005/11) 通知 本文
- 抗悪性腫瘍薬の臨床評価方法に関するガイドライン Q&A(2006/3)
- パ
ブリックコメント結果(ZIP)
FDA
- Guidance
for Industry Clinical
Trial Endpoints for the Approval of Cancer Drugs
and Biologics(2007/05)
Japanese Translation : http://jsmo.umin.jp/oshirase/20071005.html
- Guidance
for Industry Cancer
Drug and Biological Products - Clinical Data in
Marketing Applications (2001/11)
- Guidance for
Industry FDA
Approval of New Cancer Treatment Uses for Marketed Drug
and Biological Products (1998/12)
EMEA
- Guideline
on the Evaluation
of Anticancer Medicinal Products in Man
(CHMP/EWP/205/95 REV. 3) (2005/12)
- Guideline
on the Evaluation of Anticancer Medicinal Products in Man -
Methodological
Considerations for Using Progression-Free Survival (PFS)
as Primary endpoints in confirmatory trials for registration Human
(2008/01)
- Others: See "Antineoplastic and immunomodulating
agents " of Scientific Guidelines for Human Medicinal Products http://www.emea.europa.eu/htms/human/humanguidelines/efficacy.htm
Organizations
- Japanese Statistics
Guideline (4 March 1992)
- Links
- Regulatory related links
- IT/computer related links
- Useful links
HTML files are intended to use also on
small screen,
e.g. Palm and Win
CE
Original files of ICH guidelines were obtained from Regulatory
Authority
sites and are edited.
Source guidance documents are provided by Regulatory Authority mainly
as
PDF format..
See
This page is maintained by Akihiro Kobayashi.
If there are mismatches with original ICH guidelines, they due to the
editor's mistake. If you find any mistakes, please notify by email.