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English to Serbian translations [PRO]
Medical - Medical: Pharmaceuticals / veterinary medical products | | English term or phrase: the therapeutic moiety | | Those data shall include evidence that there is no change in the pharmacokinetic or pharmacodynamic properties of the therapeutic moiety and/or in toxicity, which could influence the safety/efficacy profile. |
| | | Selected response from:
Natasa Stankovic
Serbia
Local time: 16:57
| Grading comment | 4 KudoZ points were awarded for this answer |
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| Summary of reference entries provided | | |
| Discussion entries: 0 |
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Automatic update in 00:
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1 hr confidence:  
10 hrs confidence: peer agreement (net): +2 terapijsko delovanje
Explanation:
Агенција за лекове и медицинска средства Србије:
RULES ON PROCEDURE AND REQUIREMENTS FOR THE MARKETING AUTHORIZATION FOR MEDICINAL PRODUCT GRANTING
4) Additional form of an active substance (additional form of a salt, ester or other derivatives with the same therapeutic moiety );
http://www.google.rs/url?sa=t&rct=j&q=site:alims.gov.rs "the...
PRAVILNIK O POSTUPKU I USLOVIMA ZA DOBIJANJE DOZVOLE ZA STAVLJANJE LEKA U PROMET
4) novi oblik aktivne supstance (npr. drugi oblik soli, estra i drugi derivati, pri čemu je nepromenjena struktura sa terapijskim delovanjem);
http://www.alims.gov.rs/cir/regulativa/pravilnici_l.php
| Natasa Stankovic
Serbia
Local time: 16:57
Native speaker of:  Serbian
PRO pts in category: 8
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