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Pharmacokinetic modeling to support WHO-weight band dosing of a new pediatric darunavir/ritonavir (120/20 mg) fixed-dose combination tablet for children at least 3 years old and weighing 10 to less than 35 kg

IMPACT SIGNAL70/100
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Information from the abstract

BACKGROUND: Darunavir boosted with ritonavir (DRV/r) is the preferred HIV protease inhibitor for children, but no child-friendly fixed-dose combination (FDC) exists. A generic DRV/r 120/20 mg FDC tablet (6:1 ratio) is under development; however, dosing guidance across WHO weight bands is lacking. We performed a pharmacokinetic (PK) modeling/simulation study to inform dosing of the DRV/r FDC tablet in children. METHODS: Darunavir/ritonavir plasma concentration data from three pediatric HIV trials (DELPHI, ARIEL and CHAPAS-4), administered as separate formulations, were pooled to update a pediatirc population PK model. Simulations were performed for children ≥3 years old weighing 10-

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Why this record is monitored

This record has an Impact Signal of 70/100 based on recency, source, collaboration, and bibliographic signals. It prioritizes monitoring and is not a judgment of research quality.

Related topics: HIV/AIDS drug development and treatment · Pharmaceutical studies and practices · Pharmaceutical Quality and Counterfeiting

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Thai researcher and institutional participation

Marc Lallemant · Tim R. Cressey · Chiang Mai University

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Data limitations

This page is a bibliographic record based on abstract-level information, not a full analysis or quality assessment. Verify the DOI and original article before citation.