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Nausea rates from pediatric studies were excluded.
In particular, the differential diagnosis between aHUS and STEC-HUS appears to be more difficult than the stereotypical description derived from pediatric studies.
This review presents current data from pediatric studies.
This review summarizes available data from pediatric studies.
This differentiation of dengue disease severity relied on data gathered from pediatric studies.
Further, we wished to ascertain what percentage of evidence for treatment provided in the PED comes from pediatric studies.
Similar(53)
Consequently we think that our results are also more conservative that previous results obtained from various pediatric studies.
For 42% of the drugs granted pediatric exclusivity and for which information was available (50 out of 118), the information obtained from the pediatric studies led to an approved pediatric indication.
The database used in this analysis included existing plasma concentration time datasets from two pediatric studies: ARIEL; 14 DELPHI 13 after 2 weeks of treatment; two adult studies, DUET-1 and DUET-2 studies after 4 weeks of treatment, 24 and also incorporated datasets from the pediatric DIONE study and the ARIEL once-daily substudy after 2 weeks of treatment 14– 16 (Table 1).
The disparities come from exclusion of pediatric studies and inclusion of two large-scale studies.
PBPK model predicted systemic clearance values were similar to those estimated from two independent clinical pediatric studies (study 1: 1 week to 16 years, study 2: 37 weeks to 14 years) using a conventional pop-PK approach.
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