Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model-Informed Dose Selection for Pediatric Development.
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DOI: 10.1002/jcph.1990
Abstract: The BCR-ABL1 inhibitor ponatinib is approved for the treatment of adults with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia, including those with the T315I mutation. We report a population pharmacokinetic (PK) model-based analysis… read more here.
Keywords: selection pediatric; dose selection; model; population ... See more keywords
Considerations and Challenges in the Remdesivir COVID‐19 Pediatric Development Program
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DOI: 10.1002/jcph.2158
Abstract: The US Food and Drug Administration is committed to the development of effective antiviral regimens for pediatric patients with coronavirus disease 2019 (COVID‐19), including infants and neonates. On April 25, 2022, the approved indication of… read more here.
Keywords: covid pediatric; challenges remdesivir; considerations challenges; pediatric development ... See more keywords
Outcomes of the Pediatric Development Plan of Tapentadol
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DOI: 10.2147/jpr.s290487
Abstract: Abstract The opioid analgesic tapentadol was the first pain medication to be developed for the treatment of pain in children under a formal process established by the regulatory authorities. This article summarizes the outcomes of… read more here.
Keywords: outcomes pediatric; development plan; pediatric development; plan tapentadol ... See more keywords