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Guideline on the investigation of drug ...

Guideline on the investigation of drug interactions . ... Guideline on the investigation of drug interactions ... (EMEA/CHMP/EWP/185990/2006)

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

Date added: August 18, 2016 - Views: 1

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Guideline on the Investigation of Drug ...

Guideline on the Investigation of Drug ... Guideline on the Investigation of Drug Interactions . 14 15 16 17 18 19 20 21 22 23 24 25 26 27 ... (EMEA/CHMP/EWP /147013 ...

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

Date added: August 21, 2016 - 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: August 19, 2016 - Views: 1

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COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS...

... mail@emea.eudra.org http ... NOTE FOR GUIDANCE ON THE INVESTIGATION OF DRUG ... This guideline focuses on absorption interactions in the gastro ...

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

Date added: August 24, 2016 - Views: 1

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Guideline on clinical investigation of medicinal...

Guideline on clinical investigation of medicinal products in the treatment or ... Note for Guidance on the Investigation of Drug Interactions ... (EMEA/CHMP/SWP ...

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500129256

Date added: August 24, 2016 - Views: 1

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Guideline on clinical investigation of medicinal...

Guideline on clinical investigation of medicinal products for the treatment of ... • Note for guidance on the investigation of drug interactions CPMP/EWP/560/95

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500199241

Date added: August 24, 2016 - Views: 1

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Guideline on clinical investigation of medicinal...

Guideline on clinical investigation of medicinal products in ... EMEA, drug evaluation, ... Interactions ...

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500209943

Date added: August 24, 2016 - Views: 1

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2009/09/WC500003329.pdf - European Medicines...

EMEA 2004 GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS INDICATED FOR THE TREATMENT ... - Note for Guidance on the Investigation of Drug Interactions

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf

Date added: August 27, 2016 - Views: 1

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Guideline on Clinical Investigation of Medicinal...

CHMP/EWP/4713/03 ©EMEA 2006 Page 3/9 This Guideline intends to address ... on the Investigation of Drug Interactions ... on Clinical Investigation of ...

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003459.pdf

Date added: August 23, 2016 - Views: 1

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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: August 24, 2016 - Views: 1

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Guideline on clinical investigation of ... - emea...

... EMEA, Guideline, Drug ... - Guideline on clinical investigation of medicinal products for the prophylaxis ... - Investigation of drug interactions ...

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

Date added: August 24, 2016 - Views: 1

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Guidance for Industry - fda.gov

A. Relevance of Drug Interactions ..... 6 B. Drug Interaction Considerations for Small Molecule Drugs ... of the pathway under investigation.

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

Date added: August 18, 2016 - Views: 1

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Guideline on Clinical Investigation of Medicinal...

GUIDELINE ON CLINICAL INVESTIGATION OF ... ©EMEA 2007 EXECUTIVE SUMMARY This Guideline is intended to provide ... - Investigations of Drug Interactions ...

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

Date added: August 24, 2016 - Views: 1

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Guideline: On Clinical Investigation of Medicinal...

GUIDELINE ON CLINICAL INVESTIGATION ... Any comments to this Guideline should be sent to the EMEA ... - Note for Guidance on Investigation of Drug Interactions ...

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

Date added: August 24, 2016 - Views: 1

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Guideline on Clinical Investigation of Medicinal...

guideline on clinical investigation of medicinal ... cpmp/ewp/6235/04 ©emea 2006 page 2/8 guideline on clinical investigation of ... drug interactions ...

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

Date added: August 24, 2016 - Views: 1

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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE...

©EMEA 2006 Reproduction and/or distribution ... GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL ... - Note for Guidance on Investigation of Drug Interactions ...

http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003409.pdf

Date added: August 24, 2016 - Views: 1

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Guideline on: Clinical Investigation of Medicinal...

GUIDELINE ON CLINICAL INVESTIGATION OF ... Any comments to this Guideline should be sent to the EMEA EWP ... on the Investigation of Drug Interactions ...

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

Date added: August 19, 2016 - Views: 1

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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE...

EMEA 2004 Reproduction and/or distribution of this document is ... GUIDELINE ON CLINICAL INVESTIGATION OF ... Investigations of Drug Interactions, - ...

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

Date added: September 25, 2016 - Views: 1

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Guideline on the development of Medicinal Products...

... mail@emea.europa.eu http://www.emea ... GUIDELINE ON THE ... Moreover in general the CHMP Note for Guidance on the Investigation of Drug Interactions (CHMP ...

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

Date added: August 24, 2016 - Views: 2

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Guideline on Risk Management Systems ... - drug...

Post-authorisation Evaluation of Medicines for Human Use ... EMEA 2005 GUIDELINE ON RISK ... 4.5.2.4 Identified and potential interactions including food-drug and ...

http://drug.fda.moph.go.th/zone_admin/files/EPO_S_3_22chmp_riskmanage_medprd9626805_2005.pdf

Date added: September 25, 2016 - Views: 1

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Guideline on the evaluation of anticancer...

Guideline on the evaluation of ... Nonclinical evaluation for anticancer pharmaceuticals EMEA/CHMP ... Guideline on the investigation of drug interactions, ...

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

Date added: August 24, 2016 - Views: 1

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Draft Risk Management Guideline 96268

EMEA/CHMP/96268/2005 EMEA 2005 2/28 Guideline on Risk ... including food-drug and drug-drug interactions 11 ... rapid investigation of ...

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

Date added: August 24, 2016 - 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 ... • Clinical Investigation of medicinal ... • The Investigation of Drug Interactions ...

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

Date added: August 24, 2016 - Views: 1

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ICH Q1B guideline - ICH Official web site

Drug Substance ... selected as described in the Parent Guideline if the drug is clearly photostable or ... Possible interactions between the samples and any material ...

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1B/Step4/Q1B_Guideline.pdf

Date added: August 18, 2016 - Views: 3

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Consultations on adoption of European Union...

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

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

Date added: August 24, 2016 - Views: 1

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Support From Discovery to Registration

EMEA (2013) • Guideline on the Investigation of Drug Interactions PROGRAM CONSIDERATIONS • Activity and mRNA endpoints Induction Assays Inhibition

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

Date added: August 20, 2016 - 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/publicaciones/jornada/docs/POSTER_37_COPD_REV.pdf

Date added: August 24, 2016 - Views: 1

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Guideline: On The Clinical Investigation of...

EMEA 2005 GUIDELINE ON THE CLINICAL INVESTIGATION ... 5.1.3 Interactions ... The clinical profile of such a drug needs to be studied in an acute stress testing ...

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

Date added: August 31, 2016 - Views: 1

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Nonclinical Guideline - EUDIPHARM

Nonclinical Guideline ... (EMEA/CHMP/VWP/141697/2009) • Guideline on DNA vaccines ... • Guideline on the investigation of drug interactions ...

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

Date added: August 24, 2016 - Views: 1

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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE...

GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL ... EMEA 2004 GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL ... and informal social interactions such as

http://www.rsihata.com/updateguidance/emea/old/363503en.pdf

Date added: August 24, 2016 - Views: 1

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Revision January 2006 - European Commission

A GUIDELINE ON CHANGING THE CLASSIFICATION FOR THE ... This guideline is for use by marketing authorisation holders applying to ... interactions and adverse ...

http://ec.europa.eu/health/files/eudralex/vol-2/c/switchguide_160106_en.pdf

Date added: August 24, 2016 - Views: 1

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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 ...

https://united-kingdom.taylorwessing.com/fileadmin/files/docs/Pharmacogenomic_methodologies_guidelines.pdf

Date added: September 25, 2016 - 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 25, 2016 - Views: 1

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

... The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential For Non-Antiarrhythmic Drugs EMEA ... drug-drug or drug-food interactions ...

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

Date added: August 20, 2016 - Views: 1

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

and MRP2 Transporter Vesicles in Drug Development ... on Transporter-based Drug Interactions. ... Agency Guideline on the Investigation of Drug ...

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

Date added: August 23, 2016 - Views: 1

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Nfg on Clinical investigation of steroid...

EMEA 2000 1/4 CLINICAL INVESTIGATION OF STEROID ... The EU-guideline on the clinical investigation of oral contraceptives was last issued in ... interactions, adverse ...

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

Date added: September 25, 2016 - Views: 1

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DDI 2014 - cr.appliance

DDI 2014 th 5 International ... Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions was held. ... 10:45 11:15 a.m. fie New FDA Guideline ...

http://www.cr-appliance.com/fileadmin/redakteur/DDI_Workshop_2014_Final_Announcement.pdf

Date added: August 24, 2016 - Views: 1

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PERSONAL INFORMATION Siri Wang - ema.europa.eu

Drug interactions Clinical pharmacology Publications Wang S (2015) Formulations in paediatric investigation plans (PIPs): ... EMA draft guideline: ...

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500072523

Date added: September 25, 2016 - Views: 1

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02 Severin Day1 1130 The EU PIP as a Step in...

ICH E 11 Guideline: Clinical investigation of ... Evaluation procedure and Interactions ... 02_Severin_Day1_1130_The EU PIP as a Step in Pediatric Development

http://www.agah.eu/uploads/tx_news/02_Severin_The_EU_PIP_as_a_Step_in_Pediatric_Development.pdf

Date added: September 25, 2016 - Views: 1

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International Workshop on New Regulatory...

The present Note for Guidance for the Investigation of Drug Interactions by ... several areas, and the revised draft Guideline ... Die EMEA überarbeitet ...

http://www.agah.eu/uploads/media/DDI_Workshop_2010_Marbach_Castle_Background_Information.pdf

Date added: September 25, 2016 - Views: 1

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

There is increasing awareness that many clinically relevant drug interactions involving ... drug interactions, 2010, http://www.emea ... for the investigation of pre ...

https://www.researchgate.net/profile/Hannu_Raunio/publication/49674128_Simple_Direct_and_Informative_Method_for_the_Assessment_of_CYP2C19_Enzyme_Inactivation_Kinetics/links/551544170cf2b5d6a0e98279.pdf?origin=publication_detail

Date added: September 25, 2016 - Views: 1

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

estimating the magnitude of potential drugdrug interactions (DDIs); ... Agency (EMA) published a guideline on the role of pharmacogenetics methodologies in

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

Date added: August 24, 2016 - Views: 1

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Developing a Plan for Transporter-Mediated Drug...

EMA Guideline on the Investigation of Drug Interactions, ... EMA Draft Guideline on Drug Interactions ... • EMA: European Medicines Agency (formerly EMEA)

http://www.optiviabio.com/landing/webinar/OptiviaTransporterWorkshop-creating-your-tDDI-plan_23sept11.pdf

Date added: September 25, 2016 - Views: 1

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A Perspective on the Contribution of Metabolites...

The recent European Medicines Agency (EMA) Guideline on Investigation of Drug Interactions (www.ema.europa.eu/docs/en_ ... tributor to drug-drug interactions ...

http://dmd.aspetjournals.org/content/41/3/536.full.pdf

Date added: August 24, 2016 - Views: 1

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The Length of Preincubation Times in Abbreviated...

The Length of Preincubation Times in Abbreviated Cytochrome ... In the Context of Drug-Drug Interactions, ... - Draft EMEA Guideline on the Investigation of Drug ...

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

Date added: August 24, 2016 - Views: 1

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HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP)...

Good Clinical Research Practice (GCP) ... interactions, effects in target ... (EMEA), and the United States Food and Drug Administration (FDA).

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

Date added: August 18, 2016 - Views: 8

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Clinical Trial Assessment - Phase I - ICH Official...

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: August 24, 2016 - Views: 1

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SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE

SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE December 2009. 2 Content 1. Introduction 2. Chapter 1: Supplier Selection 3. Chapter 2: Due Diligence 4.

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

Date added: August 18, 2016 - Views: 5

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Definition of Investigational Medicinal Products...

Definition of Investigational Medicinal Products ... Products which are not the object of investigation ... interactions with the test medicine.

http://ec.europa.eu/health/files/pharmacos/docs/doc2006/07_2006/def_imp_2006_07_27_en.pdf

Date added: August 18, 2016 - Views: 1