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Guideline on the investigation of drug ...

Guideline on the investigation of drug interactions . ... Interaction, guideline, ... discussed in EMEA/CHMP/EWP/147013/2004 (Guideline on the role of ...

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 ...

2/38 11 Guideline on the Investigation of Drug Interactions 12 Table of contents 13 Executive summary ...

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

Date added: May 5, 2012 - Views: 15

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COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS...

... mail@emea.eudra.org http://www.eudra ... THE INVESTIGATION OF DRUG INTERACTIONS ... • The CPMP guideline on Investigation of Bioavailability and ...

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 clinical investigation of medicinal...

GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR ... EMEA, Guideline, Drug ... Possible pharmacodynamic interactions with other relevant medicinal ...

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003301.pdf

Date added: June 24, 2012 - 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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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: 13

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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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Consultations on adoption of European Union ...

Consultations on adoption of European Union ... on the Investigation of Drug Interactions and EMEA/CHMP/EWP ... 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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Guideline on clinical investigation of medicinal...

Guideline on clinical investigation of medicinal products ... • Note for Guidance on the Investigation of Drug Interactions ... (EMEA/CHMP/EWP/147013/2004)

http://www.fdanews.com/ext/resources/files/03-15/03-27-15-EMAlupusguideline.pdf?1427471226

Date added: April 5, 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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FDA Guidance on Drug - Drug Interaction Studies...

Drug Interaction Studies — Study Design, Data Analysis, Implications ... interactions, allowing the investigation of the effect of an interacting drug on the .

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...

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...

HCV RNA, EMEA, CHMP, Guideline, drug approval. ©EMEA 2008 Page 2/11 ... - Note for Guidance on the Investigation of Drug Interactions (CPMP/EWP/560/95)

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 ... 102 EMEA/CHMP/EWP/311890 ... 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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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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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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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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COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS...

... and new issues have been raised in trying to apply the existing guideline ... EMEA 1998 1/16 INVESTIGATION OF ... • The Investigation of Drug Interactions

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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Guideline on key aspects for the use of...

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

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

Date added: March 10, 2014 - Views: 2

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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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Guideline on Risk Management Systems for...

EMEA 2005 GUIDELINE ON RISK MANAGEMENT ... including food-drug and drug-drug interactions 12 ... which interactions require further investigation.

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

Date added: December 31, 2013 - Views: 2

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What is the true risk of a pharmacokinetic drug ...

Bioequivalence Guideline (EMEA/CHMP/EWP/40326/2006) as ... EMEA (1997) Note for Guidance on the Investigation of Drug Interactions (EMEA/CHMP/EWP/560/95) as of ...

http://link.springer.com/content/pdf/10.1007%2Fs00228-007-0357-6.pdf

Date added: July 6, 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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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/publicaciones/jornada/docs/POSTER_37_COPD_REV.pdf

Date added: December 11, 2012 - Views: 2

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Chapter 9 Combination Products - Kluwer Law...

... cf. also draft Guideline on Fixed Combination Medicinal Products <www.emea. ... and drug-drug interactions, ... Guideline on the investigation of ...

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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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/tx_news/DDI_Workshop_2010_Marbach_Castle_Background_Information.pdf

Date added: August 9, 2013 - Views: 1

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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 ... method for the assessment of CYP2C19 enzyme inactivation ...

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

Date added: May 7, 2013 - Views: 3

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ICH E14 Step 2: The Clinical Evaluation of QT/QTc...

EMEA Explanatory Notes ... repolarization is the subject of active investigation ... if concentrations of a drug can be increased by drug-drug or drug-food ...

http://www.fda.gov/ohrms/dockets/dockets/04d0377/04D-0377-EC7-Attach-1.pdf

Date added: May 27, 2012 - Views: 3

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

Note for Guidance on the Investigation of Drug Interactions ... Conference on Harmonisation Topic E15 guideline, pharmacogenetics is a subset ... http://www.emea ...

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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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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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.diaglobal.org/Tools/Content.aspx?type=eopdf&file=%2Fproductfiles%2F18576%2Ffiebig_douglas_3_2.pdf

Date added: July 6, 2015 - 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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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.co.uk/resources/21%20Industry_Update_Jul12.pdf

Date added: November 6, 2012 - Views: 4

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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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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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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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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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Statistical Design and Analysis I - BEBAC

... Statistical Design and Analysis I ... The Investigation of Drug Interactions ... EMEA Draft BE Guideline (2008) Acceptance limits ...

http://bebac.at/lectures/Best_Design_of_BE_Studies_5.pdf

Date added: December 23, 2012 - Views: 7

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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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E 8 General Considerations for Clinical Trials

and potential drug-drug interactions. ... © EMEA 2006 10 additional drug-drug interaction, ... active controls or of different doses of the drug under investigation.

http://www.iss.it/binary/scf1/cont/CPMP_ICH_291_95.pdf

Date added: August 9, 2013 - Views: 2

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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