Results 151 to 160 of about 270,274 (308)

Strategies to Manage Dosing Deviations and Interruptions of Cabotegravir Long‐Acting Intramuscular Injections

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Long‐acting cabotegravir is approved for HIV treatment and prevention. To guide management of dosing deviations and interruptions, concentration‐time profiles for monthly and every 2 months regimens were simulated using a population pharmacokinetic (PPK) model.
Kelong Han   +3 more
wiley   +1 more source

Burden, Risk Factors, and Knowledge of Non-fatal Opioid Overdose Among Injectable Drug Users: A Cross-sectional Study. [PDF]

open access: yesIndian J Psychol Med
Das S   +19 more
europepmc   +1 more source

Comparison of Regression and Categorical Analysis for Pharmacokinetic Data From Renal Impairment Studies

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The US Food and Drug Administration 2024 guidance prefers regression analysis over categorical analysis for pharmacokinetic data for studies that assess pharmacokinetics in patients with impaired renal functions. The objective of this study was to compare these two statistical methods for pharmacokinetic data analysis of renal impairment studies ...
Gerald Chun‐To So   +7 more
wiley   +1 more source

Re‐Evaluation of Fixed Dosing Versus Body Size‐Based Dosing Approaches for Large Molecule Therapeutics in Adults

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Wang et al.1 (2009) and Zhang et al.2 (2011) recommended a fixed dosing approach for large molecule therapeutics for first‐in‐human (FIH) trials, based on the finding that the majority of α values (body size effect on clearance) were < 0.5 across 12 monoclonal antibodies (mAbs) and 18 therapeutic proteins (TPs) and peptides, and fixed dosing provides ...
Andrew B. SyBing   +2 more
wiley   +1 more source

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