оригинальный препарат
English translation: original product
| 05:49 Sep 1, 2016 |
| Russian to English translations [PRO] Medical - Biology (-tech,-chem,micro-) / drug booklet | |||||||
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|  Selected response from: crockodile Russian Federation Local time: 17:01 | ||||||
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| Summary of answers provided | ||||
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| 4 +2 | original product |
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| 4 | innovator product |
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| 3 | original preparation/solution/drug-/initial drug etc. |
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| Discussion entries: 6 | |
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Answers
1 hr confidence: 
original preparation/solution/drug-/initial drug etc. Explanation: -- |
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4 hrs confidence:
innovator product Explanation: В терминах ВОЗ это может называться innovator product, innovator pharmaceutical product, innovator FPP (finished pharmaceutical product) См. например, тезаурус и текст "Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part" (цитаты оттуда, ссылка ниже) innovator pharmaceutical product Generally the pharmaceutical product that was first authorized for marketing (normally as a patented product) on the basis of documentation of efficacy, safety and quality. comparator product: A pharmaceutical product with which the generic product is intended to be interchangeable in clinical practice. The comparator product will normally be the innovator product for which efficacy, safety and quality have been established. If samples of the innovator product are not available, the impurity profile may also be compared to a different prequalified FPP with the same route of administration and similar characteristics (e.g. tablet versus capsule). Reference: http://apps.who.int/medicinedocs/documents/s19954en/s19954en... |
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2 mins confidence: peer agreement (net): +2
peer agreement (net): +2original product Explanation: (судя по контексту, в этом значении и употреблено) -------------------------------------------------- Note added at 1 час (2016-09-01 06:51:32 GMT) -------------------------------------------------- см. мои комментарии в обсуждении -------------------------------------------------- Note added at 1 дн4 час (2016-09-02 10:31:28 GMT) Post-grading -------------------------------------------------- Спасибо! |
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