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Additionally, planned dose-escalation in Part 1 may be stopped by mutual agreement between the Sponsor and Investigator, if the RO7062931 systemic exposure (AUC or Cmax) is > 4 times the exposure determined to saturate ASGPR occupancy after single-dose. In case dose-escalation is stopped, lower doses within the tolerated dose-range could be investigated or a dose repeated in the subsequent cohorts by mutual agreement between the Sponsor and Investigator, in order to increase the amount of data within this tolerated dose-range.
In Part 2, in case a cohort is stopped, alternative regimens within a previously tolerated dose/monthly-exposure range could be further investigated or a regimen repeated in the subsequent cohorts by mutual agreement between the Sponsor and Investigator, in order to increase the amount of data within the tolerated dose/monthly-exposure range. Due to the exploratory nature of this clinical study, its conduct can be discontinued at any time at the discretion of the Sponsor.
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