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English to English translations [PRO]
Medical - Medical (general) / clinical study for patients with hemophilia A | | English term or phrase: prestudy FVIII | At Baseline and at Day 1, subjects in the PK group will receive a single IV injection of prestudy FVIII and rFVIIIFc, respectively, over 5 (±2) minutes at a dose of 50 IU/kg.
[Why it is called "prestudy FVIII", although it is also administered during the study, here at Day 1, and not prior to the study?] |
| | | prestudy FVIII | Explanation:
I have thought of a few possibilities and hopefully you have context elsewhere that would help decide whether any of these may apply.
1) Prestudy FVIII = the same brand of FVIII (and maybe rFVIIIFc, depending on whether prestudy qualifies just FVIII or both) that the patient was using before study participation.
2) If 'prestudy' only qualifies the baseline injection, they may consider that the study starts just after this injection on day 0. The injection on day 1 is not a prestudy treatment.
3) Could this be day 0 and day 1 of a run-in period, rather than the study treatment period? |
| Selected response from:
  Helen Genevier
France
Local time: 04:05
| Grading comment Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer |
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| Discussion entries: 0 |
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Automatic update in 00:
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1 hr confidence:   peer agreement (net): +4 | prestudy fviii prestudy FVIII
Explanation:
I have thought of a few possibilities and hopefully you have context elsewhere that would help decide whether any of these may apply.
1) Prestudy FVIII = the same brand of FVIII (and maybe rFVIIIFc, depending on whether prestudy qualifies just FVIII or both) that the patient was using before study participation.
2) If 'prestudy' only qualifies the baseline injection, they may consider that the study starts just after this injection on day 0. The injection on day 1 is not a prestudy treatment.
3) Could this be day 0 and day 1 of a run-in period, rather than the study treatment period?
| Helen Genevier
France
Local time: 04:05
Specializes in field
Native speaker of:  English
PRO pts in category: 20
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| | Grading comment | Selected automatically based on peer agreement. |
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The translation workplace 
