Results 191 to 200 of about 135,512 (307)

A Review of Virtual Twins in Physiologically‐Based Pharmacokinetic Modeling and Simulation

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The novel application of Virtual Twins (VT) in PBPK (VT‐PBPK) presents the opportunity to advance precision dosing and accelerate the shift from one‐size‐fits‐all to targeted, individualized treatments. This review aims to: (1) critically evaluate existing research on the use of VTs in PBPK, (2) develop a conceptual definition of VT‐PBPK, (3) describe ...
Emily Mannix   +4 more
wiley   +1 more source

Ten‐Year Public Expenditure Savings Associated with TNF Inhibitor Biosimilars under Australia's Pharmaceutical Benefits Scheme

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Biologic therapies are a major and growing driver of pharmaceutical expenditure globally, with tumor necrosis factor (TNF) inhibitors among the most widely used and costly biologics. In Australia, these therapies are funded through the Pharmaceutical Benefits Scheme (PBS), where biosimilars offer lower cost alternatives; however, the long‐term public ...
Chin Hang Yiu   +4 more
wiley   +1 more source

Biomarker‐Based Prediction of OATP1B1 Activity in Clinical Routine—Investigating Coproporphyrins as Markers for Drug–Drug–Gene Interactions

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Coproporphyrin I (CPI) is an established endogenous biomarker for detecting drug–drug interactions (DDIs) involving the hepatic uptake transporter Organic Anion Transporting Polypeptide 1B1 (OATP1B1, gene SLCO1B1). While CPI has been extensively studied in healthy volunteers using controlled pre‐ and post‐OATP1B1‐inhibitor sampling, its applicability ...
Leila Potzel   +9 more
wiley   +1 more source

Clinical Impact of Maximum Plasma Concentration of Busulfan in Pediatric Patients Undergoing Allogenic Hematopoietic Stem Cell Transplantation

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Busulfan's narrow therapeutic index and high pharmacokinetic (PK) variability warrant investigation of its exposure–toxicity relationship. We retrospectively analyzed 334 pediatric and young adult patients who underwent allogeneic hematopoietic stem cell transplantation at Seoul National University Children's Hospital between 2009 and 2020 and received
Sungyeun Bae   +7 more
wiley   +1 more source

Digital Transformation of Medicines Regulation in Africa—Perspectives from a Stakeholder Convening

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision‐making, and protecting public health, their approaches differ according to institutional structures ...
Christelna Reyneke   +12 more
wiley   +1 more source

Repurposing Registries: Completeness of Real‐World Data for Regulatory and HTA Purposes in Three Cancer‐Focused Registries

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Despite developments in supporting the identification and selection of fit‐for‐purpose registries, a translational gap remains between the original purposes of clinically focused registries and their current and future expected use in policymaking. This study aimed to assess the extent to which cancer‐focused registries collect essential data elements ...
Manon C. Wilpshaar   +4 more
wiley   +1 more source

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