Special Populations in Clinical Trials & Clinical Practice

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A008: Using Clinical Data & Physiologically-based Pharmacokinetic Modelling to Assess the Effect of Hepatic Impairment on Avapritinib Pharmacokinetics to Guide Dose Adjustment

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A008: Using Clinical Data & Physiologically-based Pharmacokinetic Modelling to Assess the Effect of Hepatic Impairment on Avapritinib Pharmacokinetics to Guide Dose Adjustment

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078: Pharmacokinetics, Pharmacodynamics & Safety of Rusfertide, A Hepcidin Mimetic, in Subjects With Hepatic Impairment & in Subjects With Renal Impairment

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079: Exploring the Impact of Hepatic Impairment on the Pharmacokinetics of New Molecular Entities: A Comprehensive Analysis of Labeling Information

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080: Is it Time to Retire Cockcroft-Gault & “Original” Schwarz Formulas in Drug Development?

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081: Exclusion of Pediatric Patients With Renal Impairment in Clinical Trials for Antiviral Products

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082: Mechanistic Physiologically-based Pharmacokinetic Modeling to Predict Bictegravir Drug Disposition in Pregnancy

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083: Pharmacokinetics of Tenofovir Alafenamide, Emtricitabine & Dolutegravir in a Patient on Peritoneal Dialysis

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084: Exploration of Estimated Renal Function & Gabapentin Clearance in Older Adults

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164: No Clinically Relevant Effect of Moderate Hepatic Impairment on the Pharmacokinetics of Lirafugratinib

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165: Demographic Composition of New Molecular Entities Approved by the United States FDA Between 2017 & 2023 to Treat Type 2 Diabetes

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166: Fetal & Neonatal Drug Exposure Following Nipocalimab Treatment in Pregnant Women at Risk of EOS-HDFN

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167: Acetaminophen Prescribing & Pharmacokinetic Analysis in Children, Adolescents & Young Adults With Cancer

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