See veebileht kasutab küpsiseid kasutaja sessiooni andmete hoidmiseks. Veebilehe kasutamisega nõustute ETISe kasutustingimustega. Loe rohkem
Olen nõus
"Muu" projekt SARMB11016E
SARMB11016E "Vastsündinute eksponeeritus ravimites sisalduvatele lisaainetele Euroopas" (1.01.2011−31.12.2013); Vastutav täitja: Irja Lutsar; Tartu Ülikool (partner), Tartu Ülikool, Arstiteaduskond (partner); Finantseerija: Sihtasutus Eesti Teadusfond ; Eraldatud summa: 96 240 EUR.
SARMB11016E
Vastsündinute eksponeeritus ravimites sisalduvatele lisaainetele Euroopas
European Study of Neonatal Exposure to Excipients (ESNEE)
European Study of Neonatal Exposure to Excipients (ESNEE)
1.01.2011
31.12.2013
Teadus- ja arendusprojekt
Muu
ERA-Net
ETIS klassifikaatorAlamvaldkondCERCS klassifikaatorFrascati Manual’i klassifikaatorProtsent
3. Terviseuuringud3.7. Kliiniline meditsiinB660 Pediaatria 3.2. Kliiniline meditsiin (anestesioloogia, pediaatria, sünnitusabi ja günekoloogia, sisehaigused, kirurgia, stomatoloogia, neuroloogia, psühhiaatria, radioloogia, terapeutika, otorinolarüngoloogia, oftalmoloogia)100,0
AsutusRollPeriood
Tartu Ülikoolpartner01.01.2011−31.12.2013
Tartu Ülikool, Arstiteaduskondpartner01.01.2011−31.12.2013
PerioodSumma
01.01.2011−31.12.201396 240,00 EUR
96 240,00 EUR

Excipients are chemicals added to medicines to improve their quality. Sporadic reports indicate that some may be toxic for neonates and lead to significant morbidity or death. However, there is insufficient information about the risks generated by excipient exposure because systematic surveys have not been done and studies on babies have not been ethical in the past. Recent advances allow determination of excipient levels in very small blood volumes (50 microlitre) including dry blood spot methods and estimates of excipient exposure based on only 2 – 4 samples per baby. Hypothesis 1: information about exposures across the EU will promote reduction of neonatal exposure to excipients by highlighting opportunities for product substitution and priorities for reformulation. Hypothesis 2: small volume blood samples can be used to generate models of systemic excipient exposure. Our consortium comprises researchers from Estonia, France and the UK with extensive experience in all aspects of the study. We will develop a platform of techniques to assess excipient exposure including: a questionnaire and point prevalence study of neonatal excipient exposure; systematic reviews of relevant literature; dried blood spot assays for high impact excipients; a cohort study to construct population excipient kinetic models (EK, analogous to active drug pharmacokinetics or PK) for high impact excipients. This work will lead to recommendations for the European Medicines Agency and other stakeholders about assessment of excipient exposure and underpin future work to relate exposures to outcomes.
Excipients are chemicals added to medicines to improve their quality. Sporadic reports indicate that some may be toxic for neonates and lead to significant morbidity or death. However, there is insufficient information about the risks generated by excipient exposure because systematic surveys have not been done and studies on babies have not been ethical in the past. Recent advances allow determination of excipient levels in very small blood volumes (50 microlitre) including dry blood spot methods and estimates of excipient exposure based on only 2 – 4 samples per baby. Hypothesis 1: information about exposures across the EU will promote reduction of neonatal exposure to excipients by highlighting opportunities for product substitution and priorities for reformulation. Hypothesis 2: small volume blood samples can be used to generate models of systemic excipient exposure. Our consortium comprises researchers from Estonia, France and the UK with extensive experience in all aspects of the study. We will develop a platform of techniques to assess excipient exposure including: a questionnaire and point prevalence study of neonatal excipient exposure; systematic reviews of relevant literature; dried blood spot assays for high impact excipients; a cohort study to construct population excipient kinetic models (EK, analogous to active drug pharmacokinetics or PK) for high impact excipients. This work will lead to recommendations for the European Medicines Agency and other stakeholders about assessment of excipient exposure and underpin future work to relate exposures to outcomes.
KirjeldusProtsent
Rakendusuuring100,0