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05:48 Jan 25, 2021 |
Russian to English translations [PRO] Medical - Medical: Pharmaceuticals / Материалы регистрационного досье по качеству лекарственных средств | |||||||
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| Selected response from: Frank Szmulowicz, Ph. D. United States Local time: 03:24 | ||||||
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Summary of answers provided | ||||
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3 | Pharmaceutical Technology Tests |
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3 | Pharmaceutico technological testing |
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3 | scientific evaluation of medicinal products |
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Pharmaceutical Technology Tests Explanation: Analysis : Laboratory accredited by the FAMHP for analysis and quality control of drug products (pharmaceutical technology tests) : Disintegration Dissolution test of solid forms Tablet hardness test Friability of uncoated tablets http://www.ltpb-ulg.be/en/services |
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Pharmaceutico technological testing Explanation: —- |
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scientific evaluation of medicinal products Explanation: A literal translation does not mean much in the West. European medicines agency The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU). The Agency is responsible for the scientific evaluation of medicinal products developed by pharmaceutical companies in the EU. Among the extensive functions assigned, EMA is responsible for emphasizing the development of guidelines, setting standards and contribution to international cooperation activities with authorities outside the EU. All decisions are valid in all EU Member States, as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. By law, a company can only start to market a medicine once it has received a MA.[1,9] |
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