[Population Pharmacokinetics] Evaluation of omadacycline dosing regimens in Chinese using population pharmacokinetic-pharmacodynamic analysis.

2024-02-01

Purpose: Omadacycline (PTK-0796) is a first-in-class aminomethylcycline for adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible pathogens. We investigated the pharmacokinetic (PK) and pharmacodynamic (PD) profile of omadacycline, considering the impact of covariates, particularly ethnicity, on PK and determined the PK/PD cutoff values for dosing regimens.

Methods: Utilizing nonlinear mixed-effects modeling, we pooled data from 11 clinical trials for PopPK analysis. The first-order conditional......

[Population Pharmacokinetics] Population Pharmacokinetic Analysis of Dorzagliatin in Healthy Subjects and Patients with Type 2 Diabetes Mellitus.

2023-10-31

Background and objectives: Dorzagliatin is a first-in-class small molecule glucokinase activator (GKA) that improves pancreatic insulin secretion behavior and regulates hepatic glucose conversion in a glucose concentration-dependent manner. The primary objective of this study was to develop a population pharmacokinetic model of dorzagliatin to evaluate the influence of covariates, such as demographic characteristics and liver and kidney function, on the pharmacokinetics of dorzagliatin and provide a basis for medication guidance.

Method: The pharmacokinetic data of dorzagliatin in this stud......

[Exposure-Response Analysis] Exposure-Response Analyses of Tremelimumab Monotherapy or in Combination with Durvalumab in Patients with Unresectable Hepatocellular Carcinoma

2023-02-16

Abstract
Purpose: A novel single-dose regimen of 300 mg tremelimumab in combination with durvalumab [Single Tremelimumab Regular Interval Durvalumab (STRIDE)] has demonstrated a favorable benefit-risk profile in the phase I/II Study 22 (NCT02519348) and phase III HIMALAYA study (NCT03298451). This study evaluated the pharmacokinetics, exposure-response, and exposure-pharmacodynamics relationships of tremelimumab in patients with unresectable hepatocellular carcinoma (uHCC).

Patients and methods: A previous tremelimumab population pharmacokinetic model was validated using data from parts 2 ......

[Population Pharmacokinetics] Model‐based population pharmacokinetic analysis of tislelizumab in patients with advanced tumors. CPT: Pharmacometrics & Systems Pharmacology.

2022-11-04

Abstract
Tislelizumab, a humanized immunoglobulin G4 monoclonal antibody, is a programmed cell death protein 1 (PD-1) inhibitor designed to minimize Fc gamma receptor binding on macrophages to limit antibody-dependent phagocytosis, a potential mechanism of resistance to anti–PD-1 therapy. The pharmacokinetic (PK) profile of tislelizumab was analyzed with population PK modeling using 14,473 observed serum concentration data points from 2596 cancer patients who received intravenous (i.v.) tislelizumab at 0.5–10 mg/kg every 2 weeks or every 3 weeks (q3w), or a 200 mg i.v. flat dose q3w in 12 cli......

[Population Pharmacokinetics] Population Pharmacokinetics of CS1001, an Anti-Programmed Death-Ligand 1(PD-L1) Human Monoclonal Antibody(mAb), in Patients with Advanced-Stage Solid Tumor or Relapsed or Refractory Extranodal Natural Killer/T cell Lymphoma

2022-06-20