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[Population Pharmacokinetics] Population Pharmacokinetics and Exposure–ResponseAnalysis of Serplulimab in Small Cell Lung Cancer Patients

2025-09-12

ABSTRACT
While PD-L1 antibodies have demonstrated efficacy in small cell lung cancer, the therapeutic benefits remain limited. To address this unmet medical need, serplulimab was developed as an innovative monoclonal antibody targeting PD-1. This study evaluated the pharmacokinetic (PK) properties of serplulimab and their relationship with efficacy and safety in patients with extensive-stage small cell lung cancer (ES-SCLC), using population pharmacokinetics (PopPK) and exposure–response (E–R) analysis to inform dose selection. Data from 1144 patients across eight Phase I–III clinical trials ......

[Population Pharmacokinetics] Alternative Dosing Regimens of Tislelizumab Using a Pharmacometrics Model-Based Approach.

2025-03-31

Tislelizumab 200?mg once every 3?weeks (Q3W) is approved for the treatment of multiple cancers. We used a model-based approach to propose three alternative dosing regimens, 150?mg Q2W, 300?mg Q4W, and 400?mg Q6W, with the aims of providing flexible treatment regimens compatible with background chemotherapy and/or reducing infusion visits. A previously developed population pharmacokinetic model was used to simulate pharmacokinetic exposure of the alternative regimens. Regulatory guidance on alternative dosing was used to define pharmacokinetics-based criteria. Alternative doses were selected by......

[Population Pharmacokinetics] Single- and multiple-dose pharmacokinetics and safety of the SARS-CoV-2 3CL protease inhibitor RAY1216: a phase 1 study in healthy participants

2025-01-31

Abstract
Coronavirus disease 2019, which leads to pneumonia, is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). RAY1216 is a 3C-like protease inhibitor that targets SARS-CoV-2. The aim of our study was to assess the pharmacokinetics (PK) and safety of RAY1216 in healthy volunteers. This was a randomized, placebo-controlled, double-blind study consisting of four components: a single ascending dose study, a drug-drug interaction study, a multiple ascending dose study, and a food-effect study. All participants were randomly assigned to receive either a single dose or mult......

[Population Pharmacokinetics] Alternative dosing regimens of tislelizumab proposed using modeling and simulation.

2025-01-27

Abstract
394
Background: Tislelizumab (TIS; BGB-A317) is approved for the treatment of multiple solid tumors, administered at 200 mg every 3 weeks (Q3W), and has demonstrated a flat exposure–response relationship across a wide range of doses. We evaluated alternative dosing regimens of TIS at 150 mg every 2 weeks (Q2W), 300 mg every 4 weeks (Q4W), and 400 mg every 6 weeks (Q6W) using a model-based approach with the aim of alleviating patient burden by providing longer dosing intervals and/or treatment flexibility compatible with background chemotherapy to meet the needs of patients and healt......

[Population Pharmacokinetics] Population pharmacokinetic modeling and exposure-response analysis of anrikefon: insights and implications in clinical analgesia

2025-01-23

Abstract
Background: Anrikefon (HSK21542), a potent and selective peripheral kappa opioid receptor (KOR) agonist developed by Haisco, effectively blocks pain and itch signals.

Aim: To develop a population pharmacokinetic (PK) model for anrikefon and conduct exposure-response (E-R) analysis for safety and efficacy in postoperative pain patients.

Method: The Population PK analysis uses NONMEM software with data from six trials. E-R relationships were assessed using safety and efficacy data from three trials. Covariate screening and Bayesian post-hoc simulations identified relevant factors......