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- Summary of Clinical Pharmacology Studies
Sažetak ispitivanja kliničke farmakologije
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- Summary of Clinical Pharmacology Studies
Sažetak ispitivanja kliničke farmakologijeEurLex-2 EurLex-2
to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;
otkrivanju ili potvrđivanju kliničkih, farmakoloških ili drugih farmakodinamičkih učinaka jednog ili više lijekova;not-set not-set
— Summary of Clinical Pharmacology Studies
— Sažetak ispitivanja kliničke farmakologijeEurlex2019 Eurlex2019
Non-clinical pharmacology and toxicology data
Neklinički farmakološki i toksikološki podacinot-set not-set
This shall include the results of all bio-pharmaceutics studies, of clinical pharmacology studies, and of clinical efficacy and safety studies.
To obuhvaća rezultate svih biofarmaceutskih ispitivanja, kliničkih farmakoloških ispitivanja, te ispitivanja kliničke djelotvornosti i sigurnosti.EurLex-2 EurLex-2
Non-clinical pharmacology and toxicology data shall be submitted in a logical structure, such as that of Module 4 of the ICH Common Technical Document format.
Neklinički farmakološki i toksikološki podaci predaju se strukturirani na logičan način, kao što je 4. modul formata ICH zajedničkog tehničkog dokumenta.EurLex-2 EurLex-2
Non-clinical pharmacology and toxicology data shall be submitted in a logical structure, such as that of Module 4 of the ICH Common Technical Document ▌format.
Neklinički farmakološki i toksikološki podaci predaju se strukturirani na logičan način, kao što je 4. modul formata ▌ICH zajedničkog tehničkog dokumenta.not-set not-set
Providing, collecting and disseminating scientific, medical, clinical and pharmacological research information, including in the field of pharmacology and clinical trials
Pružanje, prikupljanje i širenje informacija o medicinskim, kliničkim farmakološkim istraživanjima, uključujući na području farmakoloških i kliničkih ispitivanjatmClass tmClass
The IMPD shall also contain summaries of non-clinical pharmacology and toxicology data for any investigational medicinal product used in the clinical trial in accordance with international guidance.
Dosje ispitivanog lijeka sadrži i sažetke nekliničkih farmakoloških i toksikoloških podataka za sve ispitivane lijekove koji se upotrebljavaju u kliničkom ispitivanju u skladu s međunarodnim smjernicama.EurLex-2 EurLex-2
six members appointed by the Commission, with a view to ensuring that the relevant expertise is available within the Committee, including clinical pharmacology and pharmacoepidemiology, on the basis of a public call for expressions of interest;
šest članova koje imenuje Komisija kako bi se Odboru osigurala dostupnost relevantnog znanja, uključujući kliničku farmakologiju i farmakoepidemiologiju, na temelju javnog poziva za iskaz interesa;EurLex-2 EurLex-2
Requirements for clinical and pharmacological analyses
Zahtjevi u pogledu kliničkih i farmakoloških ispitivanjaEurLex-2 EurLex-2
Providing, collecting and disseminating scientific, medical, clinical and pharmacological research information
Pružanje, prikupljanje i širenje informacija o medicinskim, kliničkim farmakološkim istraživanjimatmClass tmClass
Medical, clinical and pharmacological information retrieval services
Usluge dohvaćanja medicinskih, kliničkih i farmakoloških informacijatmClass tmClass
It will facilitate epidemiological, clinical, translational, pharmacological studies and research, fostering knowledge generation on rare diseases.
Time će se olakšati epidemiološke, kliničke, translacijske i farmakološke studije i istraživanja te će se poticati stvaranje znanja o rijetkim bolestima.elitreca-2022 elitreca-2022
Providing medical, clinical and pharmacological information
Pružanje medicinskih, kliničkih i farmakoloških informacijatmClass tmClass
(b) six members appointed by the Commission, with a view to ensuring that the relevant expertise is available within the Committee, including clinical pharmacology and pharmacoepidemiology, on the basis of a public call for expressions of interest;
(b) šest članova koje imenuje Komisija kako bi se Odboru osigurala dostupnost relevantnog znanja, uključujući kliničku farmakologiju i farmakoepidemiologiju, na temelju javnog poziva za iskaz interesa;Eurlex2019 Eurlex2019
— pre-clinical (toxicological and pharmacological) tests,
pretkliničkih (toksikoloških i farmakoloških) ispitivanja,EurLex-2 EurLex-2
– pre-clinical (toxicological and pharmacological) tests,
pretkliničkih (toksikoloških i farmakoloških) ispitivanja,EurLex-2 EurLex-2
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