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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 Interactions . ... guideline. Interactions with therapeutic proteins, ... (EMEA/CHMP/EWP/147013/2004)

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500090112

Date added: September 1, 2015 - Views: 1

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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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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 ... EMEA 2005 GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL ... possibility of drug-drug interactions need to be ...

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003410.pdf

Date added: May 17, 2012 - Views: 3

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Guideline on Clinical Investigation of Medicinal...

CPMP/EWP/6235/04 ©EMEA 2006 Page 2/8 GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR THE ... Investigation of drug interactions CPMP/EWP/560/95

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003317.pdf

Date added: December 6, 2013 - Views: 1

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Guidance for Industry - Food and Drug...

The objective of drug-drug interaction studies ... interactions, allowing the investigation of the ... Simulate drug-drug interactions Evaluate drug-drug interaction ...

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

Date added: April 27, 2012 - Views: 29

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Note for Guidance on clinical investigation of...

... mail@emea.eu.int http://www.emea.eu.int ... - Note for Guidance on the Investigation of Drug Interactions ... (see guideline ICH topic E11).

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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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 the use of pharmacogenetic...

in the pharmacokinetic evaluation of medicinal products . ... The investigation of drug interactions ... Guideline on the investigation of bioequivalence ...

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/05/WC500090323.pdf

Date added: February 22, 2013 - 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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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 ... 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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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/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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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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Supported by: New Regulatory Requirements and...

New Regulatory Requirements and Current Scientific ... EMEA Guideline on the investigation of drug ... Guidance on the investigation of Drug interactions: ...

http://www.agah.eu/uploads/tx_news/International_Drug-Drug-Interaction_Workshop_Marbach_Castle-May-June-2010-Final-Announcement.pdf

Date added: September 15, 2013 - Views: 2

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Guideline on the evaluation of anticancer...

Guideline on the evaluation of ... Nonclinical evaluation for anticancer pharmaceuticals EMEA ... Guideline on the investigation of drug interactions, CPMP/EWP/560/95 ...

http://www.fdanews.com/ext/resources/files/archives/0/01/01-11-13-EMAUpdatedAnticancerMedGuideline.pdf

Date added: September 2, 2014 - Views: 1

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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 Risk Management Systems for...

GUIDELINE ON RISK MANAGEMENT SYSTEMS FOR MEDICINAL ... 4.5.2.4 Identified and potential interactions including food-drug and drug-drug ... EMEA 2005 1.4.2. Drug ...

http://www.emwa.org/Documents/Freelancer/riskmanagement/rmp%20guidelines.pdf

Date added: May 26, 2014 - Views: 1

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Guideline on the Role of Pharmacokinetics in the...

Any comments to this Guideline should be sent to the EMEA EWP ... 2 Use of pharmacokinetics in paediatric drug ... • Clinical Investigation of medicinal ...

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

Date added: January 26, 2014 - Views: 1

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Nfg on Clinical investigation of steroid...

... mail@emea.eudra.org http://www ... The EU-guideline on the clinical investigation of oral contraceptives was ... • The Investigation of Drug Interactions

http://www.rsihata.com/updateguidance/emea/old/051998.pdf

Date added: December 6, 2013 - Views: 2

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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 ... International Transporter Consortium ...

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

Date added: December 8, 2012 - Views: 2

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Guideline: On The Clinical Investigation of...

GUIDELINE ON THE CLINICAL INVESTIGATION OF ANTI ... EMEA 2005 GUIDELINE ON THE CLINICAL ... The clinical profile of such a drug needs to be studied in an ...

http://www.rsihata.com/updateguidance/emea/2005/023495en.pdf

Date added: February 4, 2014 - Views: 1

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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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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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Guideline on key aspects for the use of...

4 Guideline on key aspects for the use ... aspects for the use of pharmacogenomic methodologies in ... and “Guideline on the Investigation of Drug Interactions

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

Date added: March 10, 2014 - 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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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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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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Codevelopment of Two or More New Investigational ...

... (such as food effect and drug interactions) ... investigated and incorporated into the combination drug development plan to identify potential

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM236669.pdf

Date added: December 27, 2011 - Views: 4

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Webinar: Application of BCRP, BSEP and MRP2...

... transporter-mediated drug interactions. 6 ... Drug Discovery (Mar 2010) 9:215-236 • EMEA DRAFT: European Medicines Agency Guideline on the Investigation of Drug ...

http://www.bdbiosciences.com/documents/webinar_2010_06_AppBCRP.pdf

Date added: January 3, 2013 - Views: 3

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

What is the true risk of a pharmacokinetic drug ... Guideline (EMEA/CHMP/EWP ... for Guidance on the Investigation of Drug Interactions (EMEA/CHMP/EWP ...

http://link.springer.com/content/pdf/10.1007%2Fs00228-007-0357-6.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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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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COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS...

The European Agency for the Evaluation of Medicinal Products ... kinetic and toxicological interactions is encouraged. The guideline is aimed ... Investigation of the ...

http://www.iss.it/binary/scf1/cont/CPMP_SWP_997_96.pdf

Date added: December 19, 2012 - Views: 3

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Nonclinical Guideline - EUDIPHARM

NONCLINICAL GUIDELINE (S) R. Baß 23-10-2012 2 . 3 Regulation Guidelines Decision EU-Member ... Drug Regulation in the EU MAH: Marketing Authorisation Holder

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

Date added: December 6, 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://www.who.int/medicines/areas/quality_safety/safety_efficacy/gcp1.pdf

Date added: March 4, 2012 - Views: 22

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The Paediatric Investigation Plan Application

... (on EMEA website) 6 ... • Within paediatric subsets – Drug-drug interactions, food effect ... Part D: “Paediatric investigation plan” (1) 17

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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Reflection Paper On Pharmacogenomics in Oncology

The investigation of drug interactions ... (EMEA/CPMP/3070/01) • Reflection paper on pharmacogenomic samples and data handling (EMEA/CHMP/201914) • A ...

http://www.gbcbiotech.com/farmacogenomica/normatividad/emea/Reflection%20paper%20on%20pharmacogenomics%20in%20oncology.pdf

Date added: September 1, 2015 - Views: 1

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Clinical Trial Assessment - Phase I - ICH

Session 6 –Clinical Trial Assessment Phase I Clinical Trial ... – Drug and food interactions ... • EMEA guidance: Guideline on strategies to identify and

http://www.ich.org/fileadmin/Public_Web_Site/Training/GCG_-_Endorsed_Training_Events/APEC_LSIF_FDA_prelim_workshop_Bangkok__Thailand_Mar_08/Day_2/Clinical_Trial_Assessment_Phase_I.pdf

Date added: February 6, 2012 - Views: 10

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Guideline on the clinical development of...

4 Guideline on the clinical ... EMEA/CPMP /EWP/2158/99 117 ... 234 should be evaluated in accordance with current CHMP Note for Guidance on the Investigation of Drug ...

http://www.learnandconfirm.ca/resources/WC500140613.pdf

Date added: November 25, 2014 - Views: 1

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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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Pharmacometrics for Regulatory Decision Making

... (e.g. the absence of suspected drug-drug interactions[3] ... the EMEA/CHMP-Think-Tank Group on Innovative Drug ... on the investigation of drug interactions ...

http://link.springer.com/content/pdf/10.2165%2F11594340-000000000-00000.pdf

Date added: September 1, 2015 - Views: 1

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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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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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SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE

SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE December 2009. ... drug / material but should also ... No market action as a result of an investigation or customer ...

http://apic.cefic.org/pub/GuidelineSupplierQualification_200912_final.pdf

Date added: September 1, 2013 - Views: 15

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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