The non-glp toleration/dose range finding study: Design and methodology used in an early toxicology screening program. Proc West Pharmacol Soc. 2009;52:94-98Herlich JA, Taggart P, Proctor J, Stahle P, Colis R, Hall L, Pugsley M (2009) The non-GLP toleration/dose range finding study: ...
Dose-Range-Finding (DRF) toxicity studies are a critical component of the preclinical development phase in drug research. These studies aim to determine the appropriate dose levels for subsequent safety studies by evaluating the tolerability and toxic effects of a compound across a range of doses....
The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM has been shown to be more accurate in targeting the MTD than traditional rule-based approach
The article offers information on the benefits of Multiple Comparison Procedure-Modelling (MCP-MOD) approach over traditional approaches for testing the doses of drugs against placebo, an ineffectual treatment for diseases.doi:10.1038/nrd4193NATURE REVIEWS DRUG DISCOVERY...
Summary Dose finding methods aiming at identifying an optimal dose of a treatment with a given schedule may be at a risk of misidentifying the best treatment for patients. We propose a phase I–II clinical trial design to find the optimal dose–schedule combination. We define schedule as the...
We propose a dose-finding weighted design for an early clinical trial which aims to determine the optimal dose, selected on the basis of both efficacy and toxicity, to be used in patients entering subsequent studies in a drug development process. The goal is to identify the optimal dose, whil...
1 Introduction1.1 MotivationA wide range of experiments in medicine, science and engineering can be mod-eled statistically as percentile-finding (more commonly known as “dose-finding”).Treatments vary by the value of a single continuous variablet, and responses aredichotomized to, say, “yes”...
Design and Analysis of Dose-Finding Studies
The majority were CIs (40%) or statisticians (39%), representing a range of experience levels. Around half had used non-algorithm-based methods. Of the 30 participating statisticians, 53% reported access to specialised statistical software to support design and analysis of model-based approaches....
Study design and treatment This was a multicenter, open-label, phase I study of brontictuzumab in subjects with certain relapsed or refractory solid tumors. The study included a dose escalation and an expansion phase. Dose escalation was conducted using an accelerated titration approach such that ...