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Subject: an internal safety assessment group pharm. Progress to the next higher dose level took place following evaluation of interim safety, PK and antibody data from the prior dose level by an internal safety assessment group. Following assessment of data from Cohort 3 (0.08 mg protein/kg), an additional cohort (Cohort 4) was included to verify exposure data at this dose level before progression to 0.16 mg protein/kg.
Progress to the next higher dose level took place following evaluation of interim safety, PK and antibody data from the prior dose level by an internal safety assessment group.Подскажите, пожалуйста, что обозначает "an internal safety assessment group"?
1. Увеличение дозы осуществлялось после предварительной оценки безопасности предыдущей дозы, ФК и образования антител ???an internal safety assessment group
2. mg protein/kg, если исследуемый препарат белковой природы, как лучше сказать "мг белка или протеина на кг"??
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