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Drug Interactions guideline - European Medicines...

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Drug Interactions guideline - European Medicines...

Guideline on the Investigation of Drug ... Pharmacokinetic interactions Pharmacokinetic interaction ... discussed in EMEA/CHMP/EWP/147013/2004 (Guideline on ...

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500129606.pdf

Date added: November 6, 2012 - Views: 26

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Guideline on the Investigation of Drug ...

Guideline on the Investigation of Drug ... recommendations and advice on which drug-drug interaction and food ... on the Investigation of Drug Interactions

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/05/WC500090112.pdf

Date added: May 11, 2012 - Views: 3

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Guideline on the Investigation of Drug ...

4 Guideline on the Investigation of Drug Interactions ... Keywords Interaction, guideline, ... 431 in EMEA/CHMP/EWP/147013/2004 (Guideline on the role of ...

http://www.solvobiotech.com/documents/Guideline_on_the_Investigation_of_Drug_Interactions-EMA-CHMP-EWP-125211-20101.pdf

Date added: May 5, 2012 - Views: 14

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COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS...

The CPMP guideline on Investigation of ... metabolic drug interactions could be ... One advantage of performing drug interaction studies early in the drug ...

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002966.pdf

Date added: December 18, 2012 - Views: 3

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Concept Paper/Recommendation on the Need for...

NOTE FOR GUIDANCE ON THE INVESTIGATION OF DRUG INTERACTIONS ... 9 in the guideline, ... transport and drug 68 interactions. 69 The EMEA CHMP Healthcare ...

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002965.pdf

Date added: May 7, 2013 - Views: 2

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Guideline on Steroid Contraceptives

EMEA 2005 GUIDELINE ON CLINICAL INVESTIGATION OF STEROID CONTRACEPTIVES ... This guideline concerns contraceptives, ... • The Investigation of Drug Interactions

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003349.pdf

Date added: December 10, 2012 - Views: 1

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Note for Guidance on clinical investigation of...

NOTE FOR GUIDANCE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE ... on the Investigation of Drug Interactions ... of this guideline because of ...

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003262.pdf

Date added: June 5, 2012 - Views: 2

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Guideline on Clinical Investigation of Medicinal...

GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS ... ©EMEA 2007 GUIDELINE ON CLINICAL ... in the treatment of migraine. This Guideline should be read in ...

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003481.pdf

Date added: February 23, 2012 - Views: 2

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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE...

This guideline will replace the “Note for guidance on the investigation of ... GUIDELINE ON THE INVESTIGATION OF ... of interactions with the drug ...

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003011.pdf

Date added: December 16, 2011 - Views: 11

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Consultations on adoption of European Union ...

... CPMP/EWP/560/95 Note for Guidance on the Investigation of Drug Interactions and EMEA/CHMP/EWP ... Appendix IV of the Guideline on the Investigation on ...

http://www.fdanews.com/ext/resources/files/06/06-14-TGA-GuidelinesList.pdf

Date added: July 23, 2014 - Views: 1

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FDA Guidance on Drug - Drug Interaction Studies...

The study of drug-drug interaction for a new drug generally begins with in vitro ... interactions, allowing the investigation of the effect of an interacting drug ...

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292362.pdf

Date added: April 27, 2012 - Views: 29

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Guideline on the development of Medicinal...

Moreover in general the CHMP Note for Guidance on the Investigation of Drug Interactions (CHMP/EWP/560/95) should ... Guideline-EMEA/382899/2008 Keywords:

http://www.maps.org/research-archive/mdma/emea_ptsd_guidelines.pdf

Date added: January 21, 2015 - Views: 1

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Guideline on: Clinical Investigation of Medicinal...

EMEA 2005 GUIDELINE ON CLINICAL INVESTIFATION OF MEDICINAL PRODUCTS FOR THE TREATMENT OF SEPSIS ... the Investigation of Drug Interactions, CPMP/EWP/560/95).

http://www.rsihata.com/updateguidance/emea/old/471303en.pdf

Date added: August 18, 2013 - Views: 2

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Guideline on: Clinical Investigation of Medicinal...

GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL ... Any comments to this Guideline should be sent to the EMEA EWP ... - Investigation of drug interactions CPMP ...

http://www.rsihata.com/updateguidance/emea/old/623504en.pdf

Date added: December 25, 2013 - Views: 3

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Guideline on the clinical evaluation of direct...

©EMEA 2008 Page 2/11 GUIDELINE ON THE CLINICAL ... on the Investigation of Drug Interactions ... on the clinical development of medicinal products for the ...

http://www.iptaonline.org/includes/News/pdfs/emea-guideline-hep-c.pdf

Date added: February 25, 2012 - Views: 7

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Draft Guideline on Clinical Investigation of...

8 Guideline on clinical investigation of medicinal products in ... 102 EMEA/CHMP/EWP ... 110 Note for Guidance on the Investigation of Drug Interactions ...

http://www.rsihata.com/updateguidance/2012/WC500136391.pdf

Date added: November 6, 2013 - Views: 1

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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE...

emea/chmp/ewp/252/03 page 2/9 emea 2004 guideline on clinical investigation of medicinal products for the treatment of neuropathic pain this guideline is intended to ...

http://palliativedrugs.com/download/emeaneuropathicpaintrials.pdf

Date added: May 28, 2013 - Views: 2

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Draft Risk Management Guideline 96268

Guideline on Risk Management ... EMEA/CHMP/96268/2005 EMEA 2005 2/28 Guideline on ... 4.5.2.7 Identified and potential interactions including food-drug ...

http://www.pharmacoepi.org/riskmgmt/emea100505.pdf

Date added: November 26, 2011 - Views: 12

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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE...

©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes ... GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS ...

http://www.rsihata.com/updateguidance/emea/2007/055595enfin.pdf

Date added: October 30, 2013 - Views: 2

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Guideline on the Role of Pharmacokinetics in the...

Any comments to this Guideline should be sent to the EMEA EWP ... • The Investigation of Drug Interactions ... on the evaluation of the pharmacokinetics of ...

http://www.rsihata.com/updateguidance/emea/old/14701304en.pdf

Date added: January 26, 2014 - Views: 1

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Guideline on Risk Management Systems for...

EMEA 2005 GUIDELINE ON RISK ... 4.5.2.4 Identified and potential interactions including food-drug and drug ... to provide rapid investigation of predicted ...

http://www.rsihata.com/updateguidance/emea/old/9626805en1.pdf

Date added: December 31, 2013 - Views: 2

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Guideline on key aspects for the use of...

4 Guideline on key aspects for the use of pharmacogenomic ... EMEA/CHMP/ 87 201914/06 88 ... EMA/CHMP/37646/2009’ and “Guideline on the Investigation of Drug ...

http://www.taylorwessing.com/fileadmin/files/docs/Pharmacogenomic_methodologies_guidelines.pdf

Date added: March 10, 2014 - Views: 2

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COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS...

... and new issues have been raised in trying to apply the existing guideline ... • The Investigation of Drug Interactions ... CPMP/EWP/QWP/1401/98 draft EMEA ...

http://reocities.com/HotSprings/Spa/6896/140198en.pdf

Date added: June 3, 2013 - Views: 3

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Supported by: New Regulatory Requirements and...

3 • Focus on the upcoming 2010 revision of the EMEA Guideline on the investigation of drug interactions • Learn and discuss regulatory

http://www.cr-appliance.com/fileadmin/redakteur/ddi-workshop-2010.pdf

Date added: October 23, 2014 - Views: 1

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Support From Discovery to Registration

ICH Guideline M3 (R2) additionally ... EMEA (2013) • Guideline on the Investigation of Drug Interactions PROGRAM CONSIDERATIONS

http://www.criver.com/files/pdfs/pcs/dmpk/dmpk_program_considerations.aspx

Date added: September 2, 2014 - Views: 1

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Revision of European guidelines on clinical ...

To describe the key aspects of the update of the European guideline on clinical investigation ... (e.g. investigation of drug interactions, ... concept paper EMEA ...

http://www.aemps.gob.es/en/publicaciones/jornada/docs/POSTER_37_COPD_REV.pdf

Date added: April 28, 2015 - Views: 1

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Leslie Z. Benet ITC Second Workshop, March 12-13,...

... which in vitro methods are suitable for studying drug interactions ... EMEA Guideline on the Investigation of Drug ... Transporter Consortium Whitepaper ...

http://www.aaps.org/uploadedFiles/Content/Sections_and_Groups/Consortiums/DTFG_ITCWebpage.pdf

Date added: December 8, 2012 - Views: 2

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International Workshop on New Regulatory...

The present Note for Guidance for the Investigation of Drug Interactions by the ... (EMEA) was issued in ... several areas, and the revised draft Guideline will be ...

http://www.agah.eu/uploads/media/DDI_Workshop_2010_Marbach_Castle_Background_Information_01.pdf

Date added: September 2, 2014 - Views: 1

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Chapter 9 Combination Products - Kluwer Law

... cf. also draft Guideline on Fixed Combination Medicinal Products <www.emea. ... possibility of a pharmacokinetic drug ... CHMP Guideline on the investigation ...

http://www.kluwerlaw.com/McmsTemplates/resources/SampleChaptersPDF/856.pdf

Date added: November 25, 2012 - Views: 12

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The Length of Preincubation Times in Abbreviated...

In the Context of Drug-Drug Interactions, ... - Draft EMEA Guideline on the Investigation of Drug Interactions ... pre-incubation times of 10

http://www.bdbiosciences.com/documents/webinar_2012_03_preincubation.pdf

Date added: December 9, 2012 - Views: 1

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Guidance for Industry - Food and Drug...

Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers U.S. Department of Health and Human Services Food and Drug Administration

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM310098.pdf

Date added: October 27, 2012 - Views: 20

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Nonclinical Guideline - EUDIPHARM

Nonclinical Guideline ... (EMEA/CHMP/SWP/4447/00) ... • Guideline on the investigation of drug interactions (CPMP/EWP/ 560/95/Rev. 1)

http://www.eudipharm.net/claroline141/DIP08d377/document/Bass_Guideline.pdf

Date added: December 6, 2013 - Views: 1

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Application of BCRP, BSEP and MRP2 Transporter...

Uptake and inhibition kinetics in vesicles • Drug development ... mediated drug interactions. 6 ... Agency Guideline on the Investigation of Drug ...

http://www.bdbiosciences.com/documents/webinar_2010_06_vesicles.pdf

Date added: September 15, 2013 - Views: 1

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What’s New in Clinical Development Practices and...

... Clinical Development Practices and Regulations ... Guideline on Drug Interactions The EMA has finalised the update to its guideline on the investigation of drug ...

http://www.s-cubed.dk/updates/resources/21-industryupdatejul12-3.pdf

Date added: October 23, 2014 - Views: 1

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The Paediatric Investigation Plan Application

“PIP guideline” (Parts A to F) ... (on EMEA website) 6 Part B: Overall development of ... – Drug-drug interactions, food effect

http://www.diahome.org/Tools/Content.aspx?type=eopdf&file=%2Fproductfiles%2F18576%2Ffiebig_douglas_3_2.pdf

Date added: March 5, 2015 - Views: 1

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Pharmacogenetics in the evaluation of new drugs: a...

Note for Guidance on the Investigation of Drug Interactions ... safety of a drug. In the guideline published in 2008 ... http://www.emea.europa.eu/ema/

http://www.nature.com/nrd/journal/v12/n2/pdf/nrd3931.pdf?WT.ec_id=NRD-201302

Date added: September 2, 2014 - Views: 1

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The EMA Bioanalytical Method Validation Guideline:...

EBF interactions 3. Content guideline 4. ... http://www.emea.europa.eu/docs/en_GB/document_library/Scientific ... ¾Guideline on the investigation of ...

http://bcn2012.europeanbioanalysisforum.eu/slides/day%203/7%20updates%20from%20the%20globe/5_van_amsterdam.pdf

Date added: February 18, 2013 - Views: 4

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Control of Genotoxic Impurities in Active...

... ICH Guideline: Impurities in New Drug Substances Q3A, ... interactions, whereas ... The EMEA guideline summarises their recommendations

http://quosa.biz/support/customers/actavis/Watson%20Articles/Laura%20-%2005-13-2013/Q9731667.pdf

Date added: March 30, 2014 - Views: 1

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26 International focus – The EU EU regulatory...

for Guidance on the Clinical Investigation of Medicinal ... Guideline on the Investigation of Drug Interactions EMA/CHMP/ EWP125211/2010 April ... EMEA/410/01 Rev 4 April

http://drupal.topra.org/sites/default/files/regrapart/1/2626/eu_focus.pdf

Date added: February 20, 2015 - Views: 2

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DMD 39:412–418, 2011 Printed in U.S.A. Simple,...

Many clinically relevant drug interactions involving ... (Guideline on the investigation of drug ... include recommendations that drug candidates need to ...

http://dmd.aspetjournals.org/content/39/3/412.full.pdf

Date added: May 7, 2013 - Views: 3

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Chapter 2 Contribution of Modeling and Simulation...

Clinical Pharmacology and Pharmacokinetics Note for guidance on the investigation of drug interactions. ... Guideline on the investigation of ... EMEA/H/C/000885 ...

http://www.springer.com/cda/content/document/cda_downloaddocument/9781441974143-c1.pdf?SGWID=0-0-45-1068438-p174028995

Date added: July 20, 2013 - Views: 2

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Study Design and Evaluation Issues 3/3 - BEBAC

Study Design and Evaluation Issues 3/3 ... The Investigation of Drug Interactions CPMP/EWP/560/95 ... EMEA Draft BE Guideline ...

http://bebac.at/lectures/Statistical_Design_and_Analysis.pdf

Date added: December 23, 2012 - Views: 3

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Standard Operating Procedures - Institute of...

EMEA/618604/08 Rev. 5 Published October 2012 Investigation of drug interactions ... CHMP guideline on clinical investigation of medicinal

http://www.icr-global.org/EasysiteWeb/getresource.axd?AssetID=11562&type=full&servicetype=Attachment

Date added: October 8, 2013 - Views: 3

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The Length of Preincubation Times in Abbreviated...

In the Context of Drug-Drug Interactions, ... time-dependent inhibition from a survey of 17 ... - Draft EMEA Guideline on the Investigation of Drug Interactions

http://www.bdj.co.jp/hkdqj200000kmtp0-att/The-Length-of-Preincubation-Times-in-Abbrebiated-Cytochrome-P450-Time-dependent-Inhibition-Studies.pdf

Date added: May 7, 2013 - Views: 1

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Considerations for planning and designing a...

Questions & Answers on the BA and BE Guideline EMEA/CHMP/EWP/40326/2006, 2006-07-26 ... The Investigation of Drug Interactions CPMP/EWP/560/95, 1997-12-17

http://bebac.at/lectures/Considerations_for_planning_and_designing_a_BE_study.pdf

Date added: December 18, 2012 - Views: 3

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Reporting and Qualification Thresholds for...

comprehensive studies for certain drug products as outlined in the EMEA Guideline on Plastic ... drug product interactions ... From this investigation, ...

http://www.pqri.org/commworking/minutes/pdfs/dptc/podpwg/Addl/PQRI_PODP_proposal_04072.pdf

Date added: February 16, 2012 - Views: 7

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Quality/Regulatory Group - MassBio

– Current focus on co-development of diagnostic + drug – Theranostics Reference: EMEA/CHMP/SAWP ... – EMEA guideline: ... • Rigid EMEA timelines balanced by ...

http://www.massbio.org/writable/committees/presentations/mbcpresentation_final_090730.pdf

Date added: March 17, 2012 - Views: 10

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Panel Discussion

(EMEA/536810/2008) Guideline on the role of pharmacokinetics in the development of medicinal products in ... Note for guidance on the investigation of drug interactions.

http://www.page-meeting.org/pdf_assets/5830-Panel%20Discussion%2006%20June.pdf

Date added: July 5, 2013 - Views: 1

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HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP)

... “Clinical investigation ... (EMEA), and the United States Food and Drug Administration ... Guideline 3) For clinical investigators, ...

http://apps.who.int/prequal/info_general/documents/GCP/gcp1.pdf

Date added: December 12, 2012 - Views: 25