Publications by authors named "U Fuhr"
Introduction: Noscapine is a commonly used cough suppressant, with ongoing research on its anti-inflammatory and anti-tumor properties. The drug has a pronounced pharmacokinetic variability.
Objective: This evaluation aims to describe the pharmacokinetics of noscapine using a semi-mechanistic population pharmacokinetic model and to identify covariates that could explain inter-individual pharmacokinetic variability.
Purpose: Currently, body weight-based dosing of rifampicin is recommended. But lately, fat-free mass (FFM) was reported to be superior to body weight (BW). The present evaluation aimed to assess the influence of body mass-related covariates on rifampicin's pharmacokinetics (PK) parameters in more detail using non-linear mixed effects modeling (NLMEM).
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- Adefovir was studied to understand how it interacts with renal transporters when combined with other drugs, showing a 20% increase in systemic exposure when used together with metformin, sitagliptin, pitavastatin, and digoxin.
- A population pharmacokinetic (popPK) model was used to analyze data from 24 healthy subjects, revealing that adefovir's absorption and bioavailability were significantly higher during combination therapy compared to when it was administered alone.
- The findings indicate that while co-administering drugs mainly influenced adefovir's absorption and conversion, its renal elimination process remained unchanged, suggesting limited drug-drug interactions in this context.
First-time-in-human (FTIH) trials are designed to generate information on the safety, tolerability, as well as the pharmacokinetic and pharmacodynamics profile of new drugs. To ensure the safety of participants, these trials need to be conducted at specifically equipped phase I clinical trial units (CTUs). In accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and the European Union (EU) regulatory guidelines, one of the aims of the European Regime Accelerator for Tuberculosis (ERA4TB) project is to collaboratively create a feasibility tool, through a partnership between public and private entities, for the validation of CTUs selected to conduct FTIH trials.
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