Glossary entry (derived from question below)
English term or phrase:
HV SC administration
Russian translation:
подкожное введение здоровым добровольцам
Added to glossary by
Oleg Lozinskiy
Oct 18, 2021 16:40
2 yrs ago
17 viewers *
English term
HV SC administration
English to Russian
Medical
Medical: Pharmaceuticals
клинические исследования
Уважаемые переводчики, подскажите как перевести следующее предложение:
σHV=residual error multiplication factor for HV SC administration
Спасибо
σHV=residual error multiplication factor for HV SC administration
Спасибо
Proposed translations
(Russian)
3 | подкожное введение здоровым добровольцам | Oleg Lozinskiy |
4 | подкожное введение здоровым добровольцам | Alieksei Seniukovich |
Change log
Oct 20, 2021 09:07: Oleg Lozinskiy Created KOG entry
Proposed translations
27 mins
Selected
подкожное введение здоровым добровольцам
HV - healthy volunteers
SC - subcutaneous
https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd...
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Note added at 43 мин (2021-10-18 17:24:34 GMT)
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Примечание к Таблице 3:
σIV=residual error multiplication factor for IV administration; σHV=residual error multiplication factor for HV SC administration; σST309=residual error multiplication factor for BN40900.
Двумя абзацами ранее указано:
The satralizumab population PK analysis was conducted in two stages. In Stage 1 (Report No. 1093049), the data from study SA-001JP (healthy subjects) were combined with data from patients with NMO/NMOSD receiving satralizumab in addition to baseline IST (BN40898) (up to 06 June 2018). A covariate analysis was performed after removing data from RA patients. In Stage 2 (Report No. 1094498), the data from the second Phase III study (BN40900) in patients receiving satralizumab as monotherapy (up to 12 October 2018) were combined with the Stage 1 dataset with additional PK data from the OLE of BN40898.
Хотя аббревиатура HV нигде больше, кроме как в этой таблице, в данном документе не встречается и в перечне сокращений не расшифровывается, но "healthy volunteers" встречаются на страницах 35 (In addition, two Phase I studies have been conducted in Japan, one in healthy volunteers (SA-001JG) and one in RA patients (SA-105JG).), 52 (Although initially the PK of satralizumab was to be studied using data from four clinical trials (one in healthy volunteers (Study SA-001JP), another one in patients with RA (Study SA-015JP) , and two in the target population (Study BN40898 and Study BN40900) , i.e. patients with NMO or NMOSD)... The final population PK model shows that the disposition of satralizumab can be described by a two-compartment model with parallel linear and Michaelis-Menten elimination, and that it depends on body weight, ADAs development, formulation (i.e. formulation for Phase I-III or market formulation) and disease status (Healthy volunteers vs patients with NMO/NMOSD)), 58 (Satralizumab dose finding was performed in two studies, including one Phase 1 single ascending dose study in Caucasian and Japanese healthy volunteers (SA-001JP) and one Phase 1b multiple dose study in Japanese RA patients (SA-105JP)) и 99 (In addition, supportive safety data are provided from 72 healthy volunteers (Study SA-001JP) and 33 RA patients (Study SA-105JP)).
SC - subcutaneous
https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd...
--------------------------------------------------
Note added at 43 мин (2021-10-18 17:24:34 GMT)
--------------------------------------------------
Примечание к Таблице 3:
σIV=residual error multiplication factor for IV administration; σHV=residual error multiplication factor for HV SC administration; σST309=residual error multiplication factor for BN40900.
Двумя абзацами ранее указано:
The satralizumab population PK analysis was conducted in two stages. In Stage 1 (Report No. 1093049), the data from study SA-001JP (healthy subjects) were combined with data from patients with NMO/NMOSD receiving satralizumab in addition to baseline IST (BN40898) (up to 06 June 2018). A covariate analysis was performed after removing data from RA patients. In Stage 2 (Report No. 1094498), the data from the second Phase III study (BN40900) in patients receiving satralizumab as monotherapy (up to 12 October 2018) were combined with the Stage 1 dataset with additional PK data from the OLE of BN40898.
Хотя аббревиатура HV нигде больше, кроме как в этой таблице, в данном документе не встречается и в перечне сокращений не расшифровывается, но "healthy volunteers" встречаются на страницах 35 (In addition, two Phase I studies have been conducted in Japan, one in healthy volunteers (SA-001JG) and one in RA patients (SA-105JG).), 52 (Although initially the PK of satralizumab was to be studied using data from four clinical trials (one in healthy volunteers (Study SA-001JP), another one in patients with RA (Study SA-015JP) , and two in the target population (Study BN40898 and Study BN40900) , i.e. patients with NMO or NMOSD)... The final population PK model shows that the disposition of satralizumab can be described by a two-compartment model with parallel linear and Michaelis-Menten elimination, and that it depends on body weight, ADAs development, formulation (i.e. formulation for Phase I-III or market formulation) and disease status (Healthy volunteers vs patients with NMO/NMOSD)), 58 (Satralizumab dose finding was performed in two studies, including one Phase 1 single ascending dose study in Caucasian and Japanese healthy volunteers (SA-001JP) and one Phase 1b multiple dose study in Japanese RA patients (SA-105JP)) и 99 (In addition, supportive safety data are provided from 72 healthy volunteers (Study SA-001JP) and 33 RA patients (Study SA-105JP)).
Note from asker:
спасибо за подсказку, я не догадалась, что это здоровые добровольцы |
4 KudoZ points awarded for this answer.
28 mins
подкожное введение здоровым добровольцам
Думаю, так.
Study BN40898 in adult and
adolescent patients with satralizumab in addition to background IST and Study BN40900 in adult patients
with satralizumab as a monotherapy. In addition, two Phase I studies have been conducted in Japan,
one in healthy volunteers (SA-001JG) and one in RA patients (SA-105JG).
https://www.ema.europa.eu/en/documents/assessment-report/ens...
https://www.researchandmarkets.com/reports/4989083/neuromyel...
Study BN40898 in adult and
adolescent patients with satralizumab in addition to background IST and Study BN40900 in adult patients
with satralizumab as a monotherapy. In addition, two Phase I studies have been conducted in Japan,
one in healthy volunteers (SA-001JG) and one in RA patients (SA-105JG).
https://www.ema.europa.eu/en/documents/assessment-report/ens...
https://www.researchandmarkets.com/reports/4989083/neuromyel...
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