Results 191 to 200 of about 373,423 (278)

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +1 more source

Trends in the utilization, expenditure and costs of noninsulin glucose‐lowering drugs in the Medicaid population: Steady increases in glucagon‐like peptide‐1 receptor agonist and sodium–glucose transporter‐2 inhibitor use, prices and expenditure

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to analyse changes in the utilization, expenditure and average cost of noninsulin glucose‐lowering drugs (GLDs) between 2008 and 2023. Methods This was a retrospective observational study of 2008–2023 data from the National Medicaid State Drug Utilization database.
Rawan O. Almadfaa
wiley   +1 more source

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló   +5 more
wiley   +1 more source

Physiologically based pharmacokinetic model combined with a clinical lactation study to determine doravirine concentrations in human breastmilk

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims To determine breastmilk concentrations of doravirine via PBPK modelling in combination with a clinical lactation study. As women living with HIV are not able to cease antiretroviral therapy during lactation, it is necessary to establish drug transfer into breastmilk to determine exposure of the infant to antiretroviral drugs and potential risk of ...
Lena van der Wekken‐Pas   +3 more
wiley   +1 more source

Effect of enzalutamide on anticoagulant therapy with edoxaban in patients with prostate cancer

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Treatment with enzalutamide in prostate cancer is challenging due to its high potential for drug–drug interactions, particularly in the typically older population of patients with frequent comorbidities treated with multiple drugs, such as anticoagulants.
Catharina J. P. Op 't Hoog   +8 more
wiley   +1 more source

N‐of‐1 trials in clinical research: Methodological foundations, statistical approaches and implementation challenges

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
N‐of‐1 trials offer a unique and rigorous methodology for evaluating individualized treatment responses, particularly within the context of personalized medicine. This article provides a comprehensive explanation of the conceptual and methodological underpinnings of N‐of‐1 trials, with particular emphasis on statistical techniques and considerations ...
Marcos Clint Leal De Carvalho   +5 more
wiley   +1 more source

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