MNI
English translation: non-investigational drug
| 15:11 Apr 30, 2017 |
| Spanish to English translations [PRO] Medical - Medical (general) / clinical trial protocol | |||||||
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|  Selected response from: Joseph Tein United States Local time: 22:17 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 4 +1 | NIMP |
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| 3 +1 | non-investigational drug |
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| 3 | AMP |
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| Discussion entries: 2 | |
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Answers
5 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1non-investigational drug Explanation: How about this suggestion? I've never seen MNI in my work before, but when I try out this guess, I find over 5,000 google entries. -------------------------------------------------- Note added at 7 mins (2017-04-30 15:18:58 GMT) -------------------------------------------------- For example: "Subject is currently participating in another clinical trial in which she is or will be exposed to an investigational or non-investigational drug or device, o ..." From the ClinicalTrials.gov web site. |
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37 mins confidence: peer agreement (net): +1
peer agreement (net): +1NIMP Explanation: "A Non Investigational Medicinal Product (NIMP) is a medicinal product which is not classed as an IMP in a trial, but may be taken by subjects during the trial." http://www.invo.org.uk/posttypejargon/non-investigational-me... "serious adverse reactions linked to a NIMP.." http://ec.europa.eu/health//sites/health/files/files/clinica... |
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1 hr confidence:
AMP Explanation: Another possibility. While looking up NIMP before, I came across this, a new directive that replaces NIMP with AMP "auxiliary medicinal products". This could be relevant if it's for Europe, there may be different guidances for the EU and the US. "The term **'auxiliary medicinal products'** replaces 'non-investigational medicinal product', referred to under the existing directive, but does not include concomitant medication." http://www.samedanltd.com/?mod=magazine&id=13&page=article&i... "In spite of an apparently clear definition of an IMP within the EU CTD, which is now incorporated into the Clinical Trial Regulation, our experience is that the designation of a medicinal product as an IMP or an ** auxiliary medical product** (AMP, previously a non-investigational medical product or NIMP) has varied between Member States. " https://www.siope.eu/wp-content/uploads/2013/09/SIOP_Europe_... "The Regulation introduces new terms which Sponsors will need to incorporate into their processes and documentation as required. For example, the term **“Auxiliary Medicinal Products”** or AMP, which basically replaces the traditionally used term of Non-Investigational Medicinal Product (NIMP)." http://blog.ispe.org/auxiliary-medicinal-products-eu-clinica... "Introduction of “Auxiliary Medicinal Product” (AMP) to replace the term “non-Investigational Medicinal Product” (NIMP), also used in EU guidances" http://eusitesolutionssummit.com/wp-content/uploads/2015/11/... |
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