Other pharmacogenetics
groups
Guidelines
Terminology
Other Pharmacogenetics groups:
The Pharmacogenetics Research Network (associated with NIH
NIGMS):
http://www.nigms.nih.gov/pharmacogenetics
The "European Federation of Pharmaceutical Industries and Associations" (EFPIA) has a "Pharmacogenetics Task Force". There is an overlap in the membership between the EFPIA Task force and the PWG. This Task Force does not have a separate website.
International CIOMS (Council for International Organizations in Medical Sciences) Working Group on Pharmacogenetics ( www.cioms.ch ). No special website
AAPS Focus Group on Pharmacogenetics and Pharmacogenomics
http://www.aapspharmaceutica.com/resources/focus/PGx
Pharmacogenetics Project Group as part of the "Arbeitsgruppe Biotechnologie-Unternehmen" of the "Verbandes der Forschenden Arzneimittelhersteller" (VFA). No special website.
PhRMA
http://genomics.phrma.org/pharmacogenomics.html
Clinical Pharmacology Subcommittee (CPSC) of the Advisory Committee for Pharmaceutical Sciences (ACPS) [23063] from (CDER) coveres subpopulation pharmacokinetic studies, exposure-response relationships in pediatric studies, and the use of pharmacogenetic tests and its impact on labeling.
|
Guideline/guidance document |
website |
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General |
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ICH E11, Clinical investigation of medicinal products in the pediatric population |
http://www.ich.org/pdfICH/e11step4.pdf |
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ICH E5, Ethnic factors in the acceptance of foreign clinical data |
http://www.ich.org/pdfICH/e5.pdf |
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ICH E4, Dose-Response Information to Support Drug Registration |
http://www.ich.org/pdfICH/e4.pdf |
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ICH M4E, The Common Technical Document for the Clinical Overview and Clinical Summary of Module 2 |
http://www.ich.org/pdfICH/_Toc20207143 |
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Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) |
http://www.cioms.ch/frame_guidelines_nov_2002.htm |
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Nuffield Council on Bioethics. Pharmacogenetics: ethical issues 2003 (consultation paper) |
http://www.nuffieldbioethics.org/filelibrary/pdf/pharmacog_consultation.pdf |
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WHO proposed international guidelines on ethical issues in medical genetics and genetic services Report of a WHO meeting on ethical issues in medical genetics (1997) |
http://www.who.int/ncd/hgn/hgnethic.htm |
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EU-related |
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CPMP Note for guidance on the investigation of bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98) |
http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf |
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CPMP Note for guidance on antiarrhytmics (CPMP/EWP/237/95) |
http://www.emea.eu.int/pdfs/human/ewp/023795en.pdf |
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Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC |
(found via IDRAC; http://idrac.oss.akzonobel.nl/htm/index.asp) |
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EU-related |
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Council of Europe, committee of ministers. Recommendation no. r (97) 5 of the committee of ministers to member stateson the protection of medical data (1997) |
http://cm.coe.int/ta/rec/1997/97r5.html |
| Working Party on human Genetics - working document on the applications of genetics for health purposes | http://www.coe.int/T/E/Legal_Affairs/Legal_co-operation/Bioethics/Activities/ Human_genetics/INF(2003)3e_genetics_working_doc.asp |
| Working Party on human Genetics - explanatory note to the working document on the applications of genetics for health purposes | http://www.coe.int/T/E/Legal_Affairs/Legal_co-operation/ Bioethics/Activities/Human_genetics/INF(2003)4e_genetics_expl_note.asp |
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US-related |
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Guidance for Industry. Pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling (draft; 1999) |
http://www.fda.gov/cber/gdlns/imphep.pdf |
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Guidance for Industry. Drug metabolism/drug interaction studies in the drug development process: studies in vitro (1997) |
http://www.fda.gov/cder/guidance/clin3.pdf |
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Guidance for Industry. In vivo drug metabolism/drug interaction studies – study design, data analysis, and recommendations for dosing and labeling (1999) |
http://www.fda.gov/cber/gdlns/metabol.pdf |
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Japan-related |
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Fundamental principles of research on the human genome (Bioethics Committee, Council for Science and Technology; 2000) |
http://www.nihs.go.jp/phar/material/material3/DiGlEngFinal011209.pdf.txt
(found via IDRAC, full text search for ‘genetic’ ‘polymorphism’) |
|
Guidelines for biological homogeneity tests of generic drugs (PMSB/ELD Notification No. 487, 1997) |
(found via IDRAC, full text search for ‘genetic’ ‘polymorphism’) |
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Concerning pharmacokinetic studies for drugs (PMSB/ELD Notification No. 796, 2001) |
(found via IDRAC, full text search for ‘genetic’ ‘polymorphism’) |
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Methods of investigation for drug interactions (PMSB/ELD Notification No. 813, 2001; Japan) |
??http://www.nihs.go.jp/phar/material/material3/DiGlEngFinal011209.pdf.txt (found via IDRAC, full text search for ‘genetic’ ‘polymorphism’) |
The EMEA has issued a leaflet on pharmacogenetics
terminology for lay public:
EMEA
terminology leaflet