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exposure response relationship

Croatian translation: odnos izloženosti i odgovora

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase: exposure response relationship
Croatian translation:odnos izloženosti i odgovora
Entered by: V&E-Team

12:50 Jul 3, 2017
English to Croatian translations [PRO]
Medical - Medical (general) / clinical trial
English term or phrase: exposure response relationship
Plasma concentration data for *abc* and AC-279 will be listed and summarized using descriptive statistics.
If data allow, population PK and PK/PD analyses will be performed to further characterize the PK profile and exposure response relationship of *abc* using measures of safety and efficacy parameters.
V&E-Team
Croatia
Local time: 09:25
odnos izloženosti i odgovora
Explanation:

1.   National competent authorities, marketing authorisation holders and the Agency shall determine the evidentiary value of a signal by using a recognised methodology taking into account the clinical relevance, quantitative strength of the association, the consistency of the data, the exposure–response relationship, the biological plausibility, experimental findings, possible analogies and the nature and quality of the data.

1.   Nacionalna nadležna tijela, nositelji odobrenja za stavljanje lijeka u promet i Agencija utvrđuju dokaznu vrijednost signala primjenom priznate metodologije uzimajući u obzir kliničku važnost, kvantitativnu snagu odnosa, dosljednost podataka, odnos izloženosti i odgovora, biološku vjerodostojnost, rezultate eksperimentalnog istraživanja, moguće analogije te prirodu i kvalitetu podataka.

http://eur-lex.europa.eu/legal-content/EN-HR/TXT/?uri=CELEX:...
Selected response from:

LogosART
Croatia
Local time: 09:25
Grading comment
hvala
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2odnos izloženosti i odgovora
LogosART
4 -1odnos reakcije na izloženost
Davor Ivic


  

Answers


5 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
odnos izloženosti i odgovora


Explanation:

1.   National competent authorities, marketing authorisation holders and the Agency shall determine the evidentiary value of a signal by using a recognised methodology taking into account the clinical relevance, quantitative strength of the association, the consistency of the data, the exposure–response relationship, the biological plausibility, experimental findings, possible analogies and the nature and quality of the data.

1.   Nacionalna nadležna tijela, nositelji odobrenja za stavljanje lijeka u promet i Agencija utvrđuju dokaznu vrijednost signala primjenom priznate metodologije uzimajući u obzir kliničku važnost, kvantitativnu snagu odnosa, dosljednost podataka, odnos izloženosti i odgovora, biološku vjerodostojnost, rezultate eksperimentalnog istraživanja, moguće analogije te prirodu i kvalitetu podataka.

http://eur-lex.europa.eu/legal-content/EN-HR/TXT/?uri=CELEX:...

LogosART
Croatia
Local time: 09:25
Specializes in field
Native speaker of: Dutch
PRO pts in category: 77
Grading comment
hvala

Peer comments on this answer (and responses from the answerer)
agree  drazenborcic
1 hr
  -> Thanks a lot! Kind regards!
agree  Jakov Milicevic
131 days
  -> Hvala!
Login to enter a peer comment (or grade)

15 days   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): -1
odnos reakcije na izloženost


Explanation:
Prijedlog

Davor Ivic
Croatia
Local time: 09:25
Specializes in field
Native speaker of: Native in CroatianCroatian, Native in EnglishEnglish
PRO pts in category: 98

Peer comments on this answer (and responses from the answerer)
disagree  Jakov Milicevic: Doslovan i besmislen prijevod.
115 days
Login to enter a peer comment (or grade)



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