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Drug Interactions guideline - European Medicines Agency

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Drug Interactions guideline - European Medicines Agency

Guideline on the Investigation of Drug Interactions . Final . Discussion in the Efficacy Working Party (EWP) June/October 1996 February 1997 . ... discussed in EMEA/CHMP/EWP/147013/2004 (Guideline on the role of pharmacokinetics in the

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

Date added: November 6, 2012 - Views: 24

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Guideline on the Investigation of Drug Interactions

Guideline on the Investigation of Drug Interactions . Draft . Discussion in the Efficacy Working Party ... the knowledge about clinical consequences of drug-drug interactions is still limited and ... in EMEA/CHMP/EWP/147013/2004 (Guideline on the role of pharmacokinetics in the development of

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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EU-EMEA - European Medicines Agency -

... mail@emea.eudra.org http://www.eudra.org/emea.html London, 17 December, 1997 CPMP/EWP/560/95 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE INVESTIGATION OF DRUG INTERACTIONS DISCUSSION IN THE EFFICACY ... • The CPMP guideline on Investigation of ...

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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Guideline on the Investigation of Drug Interactions

4 Guideline on the Investigation of Drug Interactions 5 Draft ... 6 7 This guideline replaces guideline CPMP/EWP/560/95 8 Comments should be provided using this template. The completed comments form ... 431 in EMEA/CHMP/EWP/147013/2004 (Guideline on the role of pharmacokinetics in the ...

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

Date added: May 5, 2012 - Views: 11

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Concept Paper/Recommendation on the Need for Revision of ...

NOTE FOR GUIDANCE ON THE INVESTIGATION OF DRUG INTERACTIONS (CPMP ... 51 The Working Party recommends revising the current Note for Guidance on the Investigation of 52 Interactions to provide an updated NfG ... transport and drug 68 interactions. 69 The EMEA CHMP Healthcare Professionals ...

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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Guidance for Industry - Food and Drug Administration

Drug Interaction Studies — Study Design, Data Analysis, Implications for Dosing, and Labeling ... A. Relevance of Drug Interactions ... of the pathway under investigation.

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

Date added: April 27, 2012 - Views: 24

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Guideline on: Clinical Investigation of Medicinal Products ...

EMEA 2005 GUIDELINE ON CLINICAL INVESTIFATION OF MEDICINAL PRODUCTS ... • Note for Guidance on the Investigation of Drug Interactions (CPMP/EWP/560/95) • Points to Consider on Clinical Investigation of Medicinal Products in the Treatment of

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 Products ...

GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL ... Any comments to this Guideline should be sent to the EMEA EWP Secretariat by e-mail: line.jensen@emea.eu.int or by fax: ... - Investigation of drug interactions CPMP/EWP/560/95

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

Date added: December 25, 2013 - Views: 3

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Guideline on the development of Medicinal Products in the ...

GUIDELINE ON THE DEVELOPMENT OF MEDICINAL PRODUCTS FOR THE ... Moreover in general the CHMP Note for Guidance on the Investigation of Drug Interactions (CHMP ... Guideline-EMEA/382899/2008 Keywords: Post-traumatic stress disorder (PTSD),, ...

http://www.maps.org/mdma/emea_ptsd_guidelines.pdf

Date added: September 29, 2012 - Views: 7

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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP ...

... mail@emea.eu.int http://www.emea.eu.int ... COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS INTENDED FOR THE TREATMENT OF NEUROPATHIC PAIN ... Investigations of Drug Interactions, - (EU) Note for Guidance on Fixed ...

http://www.rsihata.com/updateguidance/emea/old/025203en.pdf

Date added: August 21, 2013 - Views: 1

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Guideline on the clinical evaluation of direct acting ...

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) - Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic

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

Date added: February 25, 2012 - Views: 7

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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT ...

e-mail: mail@emea.eu.int http://www.emea.eu.int ... guideline on clinical investigation of medicinal products in the treatment of parkinson’s disease draft agreed by the efficacy working party january 2007 adoption by chmp for release for consultation 22 march 2007

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

Date added: October 30, 2013 - Views: 2

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Leslie Z. Benet ITC Second Workshop, March 12-13, 2012, Maryland

click here. to e-mail us. ITC White Paper EMEA Guideline on the Investigation of Drug Interactions. Recent ITC White Paper Presentations •

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 Role of Pharmacokinetics in the Development ...

Any comments to this Guideline should be sent to the EMEA EWP Secretariat (Fax no. +44 20 7418 8613) ... 2 Use of pharmacokinetics in paediatric drug development 4 3 Study design 5 ... • Clinical Investigation of medicinal products in the paediatric population

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

Date added: January 26, 2014 - Views: 1

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Support From Discovery to Registration

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

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

Date added: September 2, 2014 - Views: 1

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Draft Risk Management Guideline 96268 - Home | INTERNATIONAL ...

Guideline on Risk Management Systems for Medicinal Products for Human ... EMEA/CHMP/96268/2005 EMEA 2005 2/28 Guideline on Risk Management Systems for Medicinal Products for Human Use ... 4.5.2.7 Identified and potential interactions including food-drug and drug-drug interactions 11

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

Date added: November 26, 2011 - Views: 12

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Guideline on Risk Management Systems for Medicinal Products ...

emea/chmp/96268/2005 page 2/32 emea 2005 guideline on risk management systems for medicinal products for human use 1. introduction (background) 4

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

Date added: December 31, 2013 - Views: 2

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Supported by: New Regulatory Requirements and Current ...

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

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 key aspects for the use of pharmacogenomic ...

Guideline on key aspects for the use of pharmacogenomic methodologies in the ... Genomic biomarkers associated with drug-induced toxicity risk status (e.g. human 24 leukocyte antigen (HLA) ... mostly due to gene-environmental interactions.

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

Date added: March 10, 2014 - Views: 2

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Guideline on the evaluation of anticancer medicinal products ...

Guideline on the evaluation of anticancer medicinal product in man . Table of contents . 1. Introduction ..... 4 2. Scope ...

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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PRLog - Industry to meet as regulators set direction on ...

Industry to meet as regulators set direction on transporter- mediated drug interactions Source: IQPC Dated: ... version of their draft guideline on the investigation of drug interactions. ... “The publication of the ITC whitepaper and the EMEA guidelines is a very significant step forward in

http://www.prlog.org/10714115-industry-to-meet-as-regulators-set-direction-on-transporter-mediated-drug-interactions.pdf

Date added: September 2, 2014 - Views: 1

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Chapter 9 Combination Products

possibility of a pharmacokinetic drug-drug interaction could be detected. ... the profile for enzyme induction and inhibition and drug-drug interactions, ... CHMP Guideline on the investigation of bioequivalence, ...

http://www.aspenpublishers.com/AspenUI/SampleChaptersPDF/856.pdf

Date added: August 23, 2013 - Views: 2

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26 International focus – The EU EU regulatory update

Concept Paper on the Update of the Guideline on the ... for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Schizophrenia EMA/CHMP/ ... Guideline on the Investigation of Drug Interactions EMA/CHMP/ EWP125211/2010 April 2010 Adopted for 6-month public

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

Date added: October 23, 2012 - Views: 12

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The Length of Preincubation Times in Abbreviated Cytochrome ...

In the Context of Drug-Drug Interactions, there ... - Draft EMEA Guideline on the Investigation of Drug Interactions (April, 2010) Time-dependent Inhibition Testing Practices • A typical initial test is an “IC 50 ... to permit detection of TDI

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

Date added: December 9, 2012 - Views: 1

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Nonclinical Guideline

NONCLINICAL GUIDELINE (S) R. Baß 23-10-2012 2 . 3 Regulation Guidelines Decision EU-Member States to be transposed into national law Addressed to whom? ... Drug Regulation in the EU MAH: Marketing Authorisation Holder R. Baß 23-10-2012 3 .

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

Date added: December 6, 2013 - Views: 1

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International Workshop on New Regulatory Requirements and ...

The present Note for Guidance for the Investigation of Drug Interactions by the European Agency for the Evaluation ... (EMEA) was issued in ... several areas, and the revised draft Guideline will be published for public consultation in 2010. The ...

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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13 - InTech

Products for Human Use (EMEA/CHMP/96268/2005). The Guideline has been included as chapter I.3 of Volume 9A. ... which warrant further investigation to ... • Drug interactions

http://cdn.intechopen.com/pdfs/17372/InTech-Risk_management_plan_and_pharmacovigilance_system_biopharmaceuticals_biosimilars.pdf

Date added: May 24, 2013 - Views: 2

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EV Data Analysis Guideline - Europa

E-mail: mail@emea.europa.eu http://www.emea.europa.eu ... warrant investigation based on the clinical context. ... For specific ad hoc analyses i.e. drug-drug interactions, the concomitant medication can be added to the calculation.

http://eudravigilance.emea.europa.eu/human/docs/10646406en.pdf

Date added: October 25, 2013 - Views: 1

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

Many clinically relevant drug interactions involving cytochrome P450 ... screening approach for early drug interaction risk assessment. Ac-cordingly, we developed an easy and informative fluorometric ... (Guideline on the investigation of drug interactions, 2010, ...

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

Date added: May 7, 2013 - Views: 3

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Application of BCRP, BSEP and MRP2 Transporter Vesicles in ...

addressing potential transporter-mediated drug interactions. 6 ... Consortium Nature Reviews: Drug Discovery (Mar 2010) 9:215-236 • EMEA DRAFT: European Medicines Agency Guideline on the Investigation of Drug Interactions, (Apr 2010) ...

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 (CPMP/EWP/560/95/Rev. 1 Corr.*). ... relevant drug interactions and consequences ... safety of a drug. In the guideline published in 2008 (BOX 1, note 3c), ...

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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Control of Genotoxic Impurities in Active Pharmaceutical ...

... ICH Guideline: Impurities in New Drug Substances Q3A, (R2); ... interactions, whereas “mutagenicity” covers only DNA-impacting ... The EMEA guideline summarises their recommendations in the form of a decision tree (Figure 1).

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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Panel Discussion - Welcome to the Population Approach Group ...

Guideline on clinical investigation of medicinal products for the treatment of ... (EMEA/CPMP/EWP/633/02 Rev. 2) Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive ... Note for guidance on the investigation of drug interactions. (draft) ...

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 - Helmut Schütz

The Investigation of Drug Interactions CPMP/EWP/560/95 (1997) EMEA ... EMEA Draft BE Guideline (2008) Section 4.1.8 ... suggested by the FDA, not covered in any guideline; statistical evaluation not trivial…) Bioavailability, ...

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

Date added: December 23, 2012 - Views: 3

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Australian public assessment report for Ezetimibe ...

Note for Guidance on the Investigation of Drug Interactions Published: TGA Internet site Effective: ... LIPITOR is indicated in hypertensive patients with multiple risk factors for coronary heart ... EMEA/CHMP/SWP/256498/2005 Guideline on the nonclinical development of fixed combinations of ...

http://www.tga.gov.au/pdf/auspar/auspar-ezetimbe-atorvastatin-130528.pdf

Date added: November 5, 2013 - Views: 2

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

The EMA has finalised the update to its guideline on the investigation of drug interactions. The update ... The EMA has released two further modules of the guideline on good pharmacovigilance ... http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/07/news_de tail_001581 ...

http://www.s-cubed.co.uk/updates/resources/21-industryupdatejul12-1.pdf

Date added: September 2, 2014 - Views: 1

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Standard Operating Procedures - Institute of Clinical ...

EMEA/618604/08 Rev. 5 Published October 2012 Investigation of drug ... Pharmacodynamic and pharmacokinetic interactions ... CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders

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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Statistical Design and Analysis I - Helmut Schütz

5/7 | Statistical Design and Analysis I informa life scienceslife sciences ... The Investigation of Drug Interactions CPMP/EWP/560/95 (1997) EMEA ... 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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The EMA Bioanalytical Method Validation Guideline: process ...

Guideline on the validation of bioanalytical methods http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/12 ... globally acceptable and harmonized guideline on bioanalytical method validation Peter van Amsterdam, ... ¾Guideline on the investigation of Bioequivalence

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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ADAPTIVE DESIGNS AND SURROGATE ENDPOINTS: REGULATORY POINT OF ...

• FDA encourages earlier and more extensive interactions between the sponsor and the FDA than during a classical ... EMEA on surrogate endpoints ... • Guideline on clinical investigation of medicinal products used in the

http://www.bias-it.org/presentazioni/IV%20Congresso%20Nazionale%20BIAS%20-%20Padova/3_Surrogate%20endpoints/6_Frigo.pdf

Date added: May 7, 2013 - Views: 3

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Chapter 2 Contribution of Modeling and Simulation Studies in ...

Clinical Pharmacology and Pharmacokinetics Note for guidance on the investigation of drug interactions. CPMP/EWP/560/ 95 ... Guideline on the investigation of medicinal products in the term and preterm neonate. 7 DOSE ... EMEA/H/C/000885. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR ...

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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Reporting and Qualification Thresholds for Leachables in ...

comprehensive studies for certain drug products as outlined in the EMEA Guideline on Plastic Immediate Packaging. ... drug product interactions (see Figure 3). ... From this investigation, the work team will develop a science-based best practices

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/72894/2008 (January 2009) 11 ... – EMEA guideline: ... • Rigid EMEA timelines balanced by open communication

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

Date added: March 17, 2012 - Views: 10

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Risk Management Plan and Pharmacovigilance System ...

... Template for EU Risk Management Plan (EMEA/192632/2006) GMP ANNEX 20 Quality Risk Management (Feb 2008) ... which warrant further investigation to ... Drug interactions

http://www.intechopen.com/download/pdf/17372

Date added: May 7, 2013 - Views: 3

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Overview of ICH E2F – Development SafetyDevelopment Safety ...

findings related to Investigational Drug; ... Framework of DSUR Guideline ... GeneralinvestigationplanforthecomingyearGeneral investigation plan for the coming year

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2F/Presentation/ICH_E2F_step_4_October_2010.pdf

Date added: March 21, 2012 - Views: 16

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HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP)

... (ISO), “Clinical investigation of medical devices for human subjects, Part I (General require-ments) ... (EMEA), and the United States Food and Drug Administration (FDA). (See References) ... Guidelines, 2002, Guideline 7) For clinical investigators, refer to:

http://www.who.int/medicines/areas/quality_safety/safety_efficacy/gcp1.pdf

Date added: March 4, 2012 - Views: 11

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Revision of European guidelines on clinical investigation of ...

... (e.g. investigation of drug interactions, data on renal and hepatic dysfunction); ... concept paper EMEA/CHMP/EWP/8197/2009 (need for revision of the ... Preparation of initial draft guideline Collection of comments

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

Date added: December 11, 2012 - Views: 2

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E 8 General Considerations for Clinical Trials

and potential drug-drug interactions. ... © EMEA 2006 10 additional drug-drug interaction, ... treatment, active controls or of different doses of the drug under investigation. The choice of the comparator depends, among other things, ...

http://www.sergas.es/Docs/ceic/WC500002877.pdf

Date added: December 31, 2013 - Views: 2

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Regulatory Rapporteur Focus A review of the European risk ...

In November 2005, the EMEA issued a guideline on risk management ... potential interactions including food-drug and drug-drug interactions ... post-marketing period of a new drug. The focus of the guideline is on

http://www.topra.org/sites/default/files/regrapart/1/637/2006N05_Focus.pdf

Date added: December 31, 2013 - Views: 2

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Guideline on non-clinical and clinical development of similar ...

6 Guideline on non-clinical and clinical development of ... (EMEA/CHMP/BMWP/118264/2007). 14 ... 57 In addition, heparin has numerous other plasmatic and cellular interactions, but overall, in comparison

http://www.learnandconfirm.ca/resources/WC500138309.pdf

Date added: September 2, 2014 - Views: 1