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Drug Interactions guideline - European Medicines Agency

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Drug Interactions guideline - European Medicines Agency

21 June 2012 . CPMP/EWP/560/95/Rev. 1 Corr.* Committee for Human Medicinal Products (CHMP) Guideline on the Investigation of Drug Interactions . Final

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 ... in EMEA/CHMP/EWP/147013/2004 (Guideline on the role of pharmacokinetics in the development of ... Guideline on the Investigation of Drug Interactions Author: CPMP/EWP Subject: Guideline

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 ... 431 in EMEA/CHMP/EWP/147013/2004 (Guideline on the role of pharmacokinetics in the development of 432 medicinal products in the paediatric population). If an interaction study is needed, ...

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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Guidance for Industry - Food and Drug Administration

A. Relevance of Drug Interactions ... interactions, allowing the investigation of the effect of an interacting drug on the . 656 . entire pharmacokinetic profile of the substrate. Second, the PBPK model can be . 657 .

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

Date added: April 27, 2012 - Views: 24

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

NOTE FOR GUIDANCE ON THE INVESTIGATION OF DRUG INTERACTIONS (CPMP/EWP/560/95) ... 18 other areas will also need revision. Furthermore, a restructuring of the guideline may be necessary. 19 ... transport and drug 68 interactions. 69 The EMEA CHMP Healthcare Professionals Working Group will be ...

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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Consultations on adoption of European Union guidelines in ...

Guideline on the Investigation of Drug Interactions To replace: CPMP/EWP/560/95 Note for Guidance on the Investigation of Drug Interactions and EMEA/CHMP/EWP/297931/2008 Concept Paper/Recommendation on the Need for Revision of (CHMP)

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 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 ...

GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL ... EMEA 2004 GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR THE TREATMENT OF NEUROPATHIC PAIN ... Guidance on the investigation of drug interactions). Dose-Response Studies

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

Date added: May 28, 2013 - Views: 2

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Guideline on the clinical evaluation of direct acting ...

HCV RNA, EMEA, CHMP, Guideline, drug approval. ... - Note for Guidance on the Investigation of Drug Interactions (CPMP/EWP/560/95) ... approval) should take into account the possible mechanisms of interactions and the clinical need for

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

Date added: February 25, 2012 - Views: 7

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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 Risk Management Systems for Medicinal Products ...

EMEA 2005 GUIDELINE ON RISK MANAGEMENT SYSTEMS FOR MEDICINAL PRODUCTS FOR HUMAN USE ... 4.5.2.4 Identified and potential interactions including food-drug and drug-drug interactions 12 ... to provide rapid investigation of predicted or emerging safety concerns.

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

Date added: December 31, 2013 - Views: 2

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Guideline on the Role of Pharmacokinetics in the Development ...

EMEA 2005 Page 2/8 GUIDELINE ON THE ROLE OF PHARMACOKINETICS IN THE DEVELOPMENT OF MEDICINAL PRODUCTS IN THE PAEDIATRIC ... • The Investigation of Drug Interactions (CPMP/EWP/560/95) • Modified Release Oral and Transdermal Dosage Forms: Section II ...

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

Date added: January 26, 2014 - Views: 1

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

EMEA/CHMP/96268/2005 EMEA 2005 2/28 Guideline on Risk Management Systems for Medicinal Products for Human ... 4.5.2.7 Identified and potential interactions including food-drug and drug-drug interactions 11 ... It should be stated which interactions require further investigation. 4.5.2.8 ...

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

Date added: November 26, 2011 - Views: 12

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Guideline on Ulcerative Colitis - For Release for Consultation

©EMEA 2006 Page 2/9 GUIDELINE ON THE DEVELOPMENT OF NEW MEDICINAL PRODUCTS FOR THE TREATMENT OF ULCERATIVE COLITIS TABLE OF CONTENTS 1. INTRODUCTION ... • Note for Guidance on the Investigation of Drug Interactions (CPMP/EWP/560/95)

http://www.rsihata.com/updateguidance/emea/2006/1846306endraft.pdf

Date added: February 28, 2014 - Views: 1

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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 ...

4 Guideline on key aspects for the use of pharmacogenomic ... EMEA/CHMP/ICH/380636/2009 (ICH Topic E16). ... EMA/CHMP/37646/2009’ and “Guideline on the Investigation of Drug Interactions 117 CPMP/EWP/560/95/Rev. 1”. 118 However, ...

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

Date added: March 10, 2014 - Views: 1

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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

... mail@emea.eu.int http ... London, 18 November 2004 CHMP/EWP/3635/03 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR THE ... Moreover in general the note for guidance on drug interactions should be ...

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

Date added: August 9, 2013 - Views: 2

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The Length of Preincubation Times in Abbreviated Cytochrome ...

In the Context of Drug-Drug Interactions, there are Generally Two Types of CYP Inhibition ... - Draft EMEA Guideline on the Investigation of Drug Interactions (April, 2010) Time-dependent Inhibition Testing Practices • A typical initial test is an “IC 50

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

Date added: December 9, 2012 - Views: 1

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Guideline on the evaluation of anticancer medicinal products ...

Guideline on the evaluation of anticancer medicinal ... Guideline on the investigation of drug interactions, CPMP/EWP/560/95/Rev. 1 ... Reflection paper on pharmacogenomis in oncology EMEA/CHMP/PGxWP/128435/2006.

http://www.rsihata.com/updateguidance/2013/WC500137128.pdf

Date added: June 13, 2013 - Views: 1

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26 International focus – The EU EU regulatory update

Guideline on the Clinical Evaluation of Antifungal Agents for ... Guideline on the Investigation of Drug Interactions EMA/CHMP/ EWP125211/2010 April 2010 Adopted for 6-month public ... EMEA/410/01 Rev 4 April 2010 Adopted and will now be transmitted

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

Date added: October 23, 2012 - Views: 10

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Co-sponsored by: Workshop Fee (incl. Lunch, Dinner & Coffee ...

Preclinical and Clinical Investigation of Drug-Drug Interactions First Announcement May 30th to June 01st, 2010 Marbach Castle, Germany Co-sponsored by: ... revision of the EMEA Guideline on the investigation of drug interactions

http://www.agah.eu/uploads/media/First_Announcement_DDI_Workshop_2010_Marbach_Castle_01.pdf

Date added: May 7, 2013 - Views: 6

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13 - InTech

... (EMEA/CHMP/96268/2005). The Guideline has been included as chapter I.3 of Volume 9A. Annex C: ... • Drug interactions ... investigation www.intechopen.com. Risk Management Trends 256

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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Chapter 9 Combination Products - Kluwer Law

... cf. also draft Guideline on Fixed Combination Medicinal Products <www.emea. ... the profile for enzyme induction and inhibition and drug-drug interactions, ... CHMP Guideline on the investigation of bioequivalence, ...

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

Date added: November 25, 2012 - Views: 12

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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 ... drug interactions, 2010, http://www.emea.europa.eu/htms/human/ humanguidelines/efficacy.htm) for in vitro drug interaction studies ... allowing investigation of

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

Date added: May 7, 2013 - Views: 3

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

(2008) A Regulatory Viewpoint on Transporter-based Drug Interactions. ... 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_AppBCRP.pdf

Date added: January 3, 2013 - Views: 2

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Study Design and Evaluation Issues 3/3 - Helmut Schütz

The Investigation of Drug Interactions CPMP/EWP/560/95 (1997) EMEA Fixed Combination Medicinal Products CPMP/EWP/240/95 Rev. 1 (2008) ... EMEA Draft BE Guideline (2008) Acceptance limits [...] at steady state AUC τ, Cmax,ss, and Cmin,ss should be

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

Date added: December 23, 2012 - Views: 3

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Control of Genotoxic Impurities in Active Pharmaceutical ...

investigation. When focusing on safety, particular attention is ... ICH Guideline: Impurities in New Drug Substances Q3A, (R2); ... European Medicines Evaluation Agency, Committee for Medicinal Products for Human Use (CHMP): ...

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 sepsis. ... (EMEA/536810/2008) Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric ... 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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Statistical Design and Analysis I - Helmut Schütz

The Investigation of Drug Interactions CPMP/EWP/560/95 (1997) EMEA ... Draft Guideline on the Investigation of Bioequivalence (2008) ... EMEA Draft BE Guideline (2008) Acceptance limits [...] at steady state AUC τ, ...

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 ...

EBF interactions 3. Content guideline 4. Points of attention 5. References 16-Nov-12 2. ... bioanalytical methods applied to measure drug concentrations in ... 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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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://moodle.univ-lille2.fr/pluginfile.php/47514/mod_resource/content/1/nrd3931%20Pharmacogenetics%20in%20the%20evaluation%20of%20new%20drugs.pdf

Date added: May 20, 2014 - Views: 1

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D80AR Clinical Guidance rev10.10

Safety related to drug-drug interactions and other interactions..... 21 4.9. Discontinuation due to ... pursuant to article 14(9) of Regulation (EC) No 726/2004. See relevant CHMP guideline (EMEA/419127/05) ... Indicate whether a Paediatric Investigation Plan (with or without deferral) ...

http://www.rsihata.com/updateguidance/2010/WC500004856.pdf

Date added: June 4, 2013 - Views: 1

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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 ... aimed at ascertaining the product safety impact of interactions between OINPD drug products ... 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_04071.pdf

Date added: April 17, 2012 - Views: 3

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Revision of European guidelines on clinical investigation of ...

To describe the key aspects of the update of the European guideline on clinical investigation of medicinal products in the treatment of chronic ... (e.g. investigation of drug interactions, data on renal and hepatic dysfunction); ... concept paper EMEA/CHMP/EWP/8197/2009 (need for revision of the

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 2 Contribution of Modeling and Simulation Studies in ...

EMEA/536810/08). The pediatric ... Guideline on the investigation of medicinal products in the term and preterm neonate. 7 DOSE-FINDING …. PK/PD modelling techniques, ... drugdrug interactions because of the mode of action was greatly enhanced by the

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

... (EMEA, 2002, 2006) –Attractive design (Uchida, 2006) ... • FDA encourages earlier and more extensive interactions between the sponsor and the FDA than during a classical ... • 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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Quality/Regulatory Group - MassBio

– Current focus on co-development of diagnostic + drug – Theranostics Reference: EMEA/CHMP/SAWP/72894/2008 (January 2009) 11 ... Pediatric Investigation Plan ... – EMEA guideline: ...

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

Date added: March 17, 2012 - Views: 10

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Australian public assessment report for Ezetimibe ...

EMEA/CHMP/EWP/311890/2007 (pdf,105kb) ... Note for Guidance on the Investigation of Drug Interactions Published: TGA Internet site Effective: ... EMEA/CHMP/SWP/256498/2005 Guideline on the nonclinical development of fixed combinations of medicinal

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

Date added: November 5, 2013 - Views: 2

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Risk Management Plan and Pharmacovigilance System ...

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://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 ... Interactions Experiences during pregnancy Oth i kOther risks

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: 15

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HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP)

... Consolidated Guideline and is organized as a ... measures, precautions, interactions, effects in target populations and safety information. ... (EMEA), and the United States Food and Drug Administration (FDA). (See References)

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

Date added: March 4, 2012 - Views: 10

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The Length of Preincubation Times in Abbreviated Cytochrome ...

In the Context of Drug-Drug Interactions, there ... EMEA • “…If the ... - Draft EMEA Guideline on the Investigation of Drug Interactions (April, 2010) Time-dependent Inhibition Testing Practices • A typical initial test is an “IC 50 shift” assay

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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Session 6 - Clinical Trial Assessment - Phase I - LOURENCO ...

EMEA guidance: Guideline on strategies to identify and ... surrogates for thorough investigation of the ... – Food-effect and drug-drug interactions – Thorough QT/QTc • Phase I studies in patients where drug is known

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: 8

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Risk Management in Pharmacovigilance - Agência Nacional de ...

further investigation to refine the understanding of the risk- ... appropriately, e.g. drug interactions. Monitoring effectiveness of RM ... • EMA shall adopt scientific guideline (not expexed before end of 2012) S Strauss .

http://portal.anvisa.gov.br/wps/wcm/connect/a2e976004f48972c80b4d8d785749fbd/APT+1.pdf?MOD=AJPERES&attachment=true&id=1366124069465

Date added: July 5, 2013 - Views: 1

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Recommendation from the New Drugs Committee

levetiracetam include low intra- and inter-subject pharmacokinetic variability and fewer drug-drug interactions. ... (EMEA) guidelines for both the clinical investigation of medicinal products in the treatment of epileptic disorders and for

http://www.scottishmedicines.org.uk/files/levetiracetam_250_500_750_and_1000mg_tabs_and_oral_solution_100mg1ml__Keppra__Mono_Resub_FINAL_Jan_2008_for_website.pdf

Date added: September 14, 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 ... outstanding safety questions that warrant further investigation to fully ... potential interactions including food-drug and drug-drug interactions

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

Date added: December 31, 2013 - Views: 2

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European Bioanalysis Forum and the way forward towards ...

such as the interactions established in the USA ... in meetings before delivery back to the EMEA (e.g., guidance on drug in control samples [8]). ... 108 EMEA. Investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98

http://www.future-science.com/doi/pdf/10.4155/bio.09.96

Date added: July 23, 2014 - Views: 1

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Index [www.pharmagateway.net]

drug product, 111 investigation of oxidative degradation, 111 ... EMEA guideline scope, 120–121 PhRMA position paper and staged TTC approach, 119, 120 ... new drug-excipient interactions, 113–114 desired state benefits, 104

http://www.pharmagateway.net/PDFDocuments/Books/BookID1135/Chapter_backmatter/978-1-4419-0888-9_huynh-ba_bm.pdf

Date added: September 24, 2012 - Views: 4

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COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR ...

... mail@emea.eudra.org http://www.eudra.org/emea.html ... kinetic and toxicological interactions is encouraged. The guideline is aimed at formulating recommendations for pharmacodynamic investigations ... Investigation of the possible induction of resistance by long-term exposure of cell lines

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

Date added: December 19, 2012 - Views: 3