pediatric or juvenile animal studies

Russian translation: исследования у детей или молодых особей животных

09:33 Feb 6, 2018
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: pediatric or juvenile animal studies
No formal pediatric or juvenile animal studies have been performed; however, there has been limited study of the safety and efficacy of sunitinib in pediatric patients
Maxim Polukhin
Local time: 02:14
Russian translation:исследования у детей или молодых особей животных
Explanation:
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Note added at 30 mins (2018-02-06 10:03:43 GMT)
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Официальных исследований у детей или молодых особей животных не проводилось, однако у детей было проведено ограниченное исследование безопасности и эффективности сунитиниба.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149978/
Phase I and Pharmacokinetic Study of Sunitinib in Pediatric Patients with Refractory Solid Tumors: A Children’s Oncology Group Study

https://ec.europa.eu/health/documents/community-register/200...
Paediatric use: The safety and efficacy of SUTENT in paediatric patients have not been established. SUTENT should not be used in paediatric population until further data become available.
Selected response from:

Margarita Vidkovskaia
Russian Federation
Local time: 02:14
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1исследования у детей или молодых особей животных
Margarita Vidkovskaia
4исследования с участием детей или на неполовозрелых животных
Ulyana Rozhkova
4испытания на детях или животных ювенального возраста
Elena Evdokimova


Discussion entries: 2





  

Answers


13 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
исследования у детей или молодых особей животных


Explanation:
.

--------------------------------------------------
Note added at 30 mins (2018-02-06 10:03:43 GMT)
--------------------------------------------------

Официальных исследований у детей или молодых особей животных не проводилось, однако у детей было проведено ограниченное исследование безопасности и эффективности сунитиниба.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149978/
Phase I and Pharmacokinetic Study of Sunitinib in Pediatric Patients with Refractory Solid Tumors: A Children’s Oncology Group Study

https://ec.europa.eu/health/documents/community-register/200...
Paediatric use: The safety and efficacy of SUTENT in paediatric patients have not been established. SUTENT should not be used in paediatric population until further data become available.

Margarita Vidkovskaia
Russian Federation
Local time: 02:14
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 757
Grading comment
Спасибо!

Peer comments on this answer (and responses from the answerer)
agree  Doctor Alex
1 hr
  -> Спасибо!
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
испытания на детях или животных ювенального возраста


Explanation:
испытания (препарата ) на детях или животных ювенального возраста

Не проводилось никаких официальных исследований на детях и животных ювенального возраста; однако, было проведено ограниченное исследование безопасности и эффективности сунитиниба для пациентов детского возраста.


Neonatal/Juvenile Animal Studies: FDA Perspectives

Definition of “juvenile” – animal in period between birth and attainment of sexual maturation
They are toxicology studies in very young animals vs adult data which covers treatment in rats from eg >6 weeks of age and dogs from eg >6 months of ag
https://www.fda.gov/ohrms/dockets/ac/04/slides/4028S1_11_Has...

Elena Evdokimova
Local time: 02:14
Works in field
Native speaker of: Native in RussianRussian
PRO pts in category: 50
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24 days   confidence: Answerer confidence 4/5Answerer confidence 4/5
исследования с участием детей или на неполовозрелых животных


Explanation:
в документах и руководствах чаще используется термин "неполовозрелые"

Ulyana Rozhkova
Belarus
Local time: 02:14
Specializes in field
Native speaker of: Native in RussianRussian
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