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Guideline on the investigation of drug...

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Guideline on the investigation of drug...

Jun 21, 2012 ... CPMP/EWP/560/95/Rev. 1 Corr. 2**. Committee for Human Medicinal Products ( CHMP). Guideline on the investigation of drug interactions.

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

Date added: November 6, 2012 - Views: 37

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Guideline on the Investigation of Drug...

Apr 22, 2010 ... CPMP/EWP/560/95/Rev. 1 – Corr.*. Committee for Human Medicinal Products ( CHMP). Guideline 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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Overview of comments received on Guideline on the...

Aug 1, 2013 ... Association of the European Self-Medication Industry (AESGP). 10 ... In the guidelines relative to the investigation of drug interaction, you.

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/08/WC500147164.pdf

Date added: May 21, 2014 - Views: 1

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committee for proprietary medicinal products - ...

Dec 17, 1997 ... THE INVESTIGATION OF DRUG INTERACTIONS ... The CPMP guideline on clinical investigation of medicinal products in children.

http://www.rsihata.com/updateguidance/emea/old/056095en.pdf

Date added: October 10, 2015 - Views: 1

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Drug Interaction Studies -- Study Design, Data...

DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only. ... B. Drug Interaction Considerations for Small Molecule Drugs...... .................................. 7 ..... of the pathway under investigation. Strong inhibitors and ...

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm292362.pdf

Date added: April 27, 2012 - Views: 33

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A Comparison of USFDA and EMA

Overview of recent drug-drug interaction guidance from the. FDA and EMA ... Interaction Studies” “Guideline on the Investigation of. ' Draft Guidance — Issued ...

https://www.bdj.co.jp/hkdqj200000kmtp0-att/FDA-EMA_Induction-Guidance.pdf

Date added: February 1, 2016 - Views: 1

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Guideline on the Clinical Investigation of the...

E-mail: mail@emea.europa.eu http://www.emea.europa.eu. ©EMEA 2007 .... The Investigation of Drug Interaction (CPMP/EWP/560/95). • The Investigation of ...

http://baishengjinze.gotoip2.com/uploadsabcd/allimg/file/20150810/20150810152043_77895.pdf

Date added: December 2, 2015 - Views: 1

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Draft guideline on the clinical development of...

Sep 19, 2013 ... This guideline replaces EMEA/CPMP/EWP/633/02 Rev 2. 8. 9. Comments should ..... Investigation of drug interactions – CPMP/EWP/560/95. 99.

http://www.fdanews.com/ext/resources/files/10/10-01-13-Antiretrovirals.pdf

Date added: October 12, 2014 - Views: 1

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Guideline on clinical development of fixed...

May 13, 2015 ... Committee for Human Medicinal Products (CHMP). 3 ... [email protected] europa.eu. .... Guideline on the Investigation of Drug Interactions- ...

http://www.fdanews.com/ext/resources/files/05-15/05-13-15-EMAFDCguideline.pdf?1431527069

Date added: May 28, 2015 - Views: 1

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Note for guidance on the Investigation of...

The European Agency for the Evaluation of Medicinal Products. Evaluation .... Investigation of Chiral Active Substances. ... The Investigation of Drug Interactions.

http://apps.who.int/prequal/info_applicants/BE/emea_bioequiv.pdf

Date added: February 4, 2012 - Views: 6

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Consultations on adoption of European Union ...

Jun 17, 2014 ... To replace: CPMP/EWP/560/95 Note for Guidance on the Investigation of Drug Interactions and. EMEA/CHMP/EWP/297931/2008 Concept ...

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...

Mar 26, 2015 ... Committee for Medicinal Products for Human Use (CHMP). Guideline on ..... Note for guidance on clinical investigation of drug interactions ...

http://www.thehumanmotioninstitute.org/sites/default/files/WC500185161.pdf

Date added: October 10, 2015 - Views: 1

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Chapter 5 Clinical relevance of drug-drug...

for Guidance on the 'Investigation of drug interactions', giving guidelines for studies on drug interactions ... European Public Assessment Reports (EPARs) [ 31].

http://www.rug.nl/research/portal/files/2896822/c5.pdf

Date added: April 25, 2016 - Views: 1

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Draft GL on clinical medicinal products intended...

May 30, 2013 ... Committee for Medicinal Products for Human Use (CHMP). 3. Guideline on ..... Guidance on the investigation of drug interactions). Efficacy and ...

http://www.learnandconfirm.ca/resources/WC500143769.pdf

Date added: February 1, 2016 - Views: 1

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DrugDrug Interactions Related to Altered...

Dec 30, 2014 ... Keywords: drug interactions; absorption; protein binding; regulatory science; drug development; drug ... and European Medicines Agency (EMA), to publish guidance ...... for guidance on the investigation on drug interactions.

http://www.jpharmsci.org/article/S0022-3549(16)30016-8/pdf

Date added: April 25, 2016 - Views: 1

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Reflection paper on Pharmacogenetics and PK...

3) The investigation of drug interactions (CPMP/EWP/560/95). 4) Note for ... 7) A guideline on summary of product characteristics (EMEA/CHMP/64302/2005). 2.

http://www.gbcbiotech.com/farmacogenomica/normatividad/emea/reflection%20paper%20on%20the%20use%20of%20pharmacogenetics%20in%20the%20pharmacokinetic%20evalution%20of%20medicinal%20products.pdf

Date added: October 10, 2015 - Views: 1

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Download this document - Association of the...

European Federation of Pharmaceutical Industries and Associations. EMA ..... neonate (EMEA/536810/2008), Guideline on the investigation of drug interactions.

http://www.abpi.org.uk/our-work/library/medical-disease/Documents/pbpkmodelling.pdf

Date added: November 2, 2015 - Views: 1

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New Regulatory Requirements and Current Scientific...

May 31, 2010 ... The present European Note for Guidance on the Investigation of Drug Interactions (CPMP / EWP / 560 / 95) by the European. Agency for the ...

http://www.ddi-workshop-marbach.org/fileadmin/redakteur_ddi/1st_International_Marbach_Castle_DDI_Workshop_2010-Final_Programme.pdf

Date added: April 25, 2016 - Views: 1

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Guideline on the clinical evaluation of direct...

Apr 24, 2008 ... HCV RNA, EMEA, CHMP, Guideline, drug approval. ..... Note for Guidance on the Investigation of Drug Interactions (CPMP/EWP/560/95).

http://www.mivado.com/intelligent/pdf/emea/3003908en.pdf

Date added: February 1, 2016 - Views: 1

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Evaluation of utility of pharmacokinetic studies 1...

Running Title: Utility of pharmacokinetic drug-drug interaction studies. 11. 12 ..... EMEA, Note for Guidance On The Investigation of Drug Interactions. 22 April.

http://clincancerres.aacrjournals.org/content/early/2013/09/20/1078-0432.CCR-13-0597.full.pdf

Date added: April 25, 2016 - Views: 1