Comparative Analyses of Bioequivalence Assessment Methods for In Vitro Permeation Test Data [0.03%]
基于体外渗透试验数据的生物等效性评价方法比较分析
Sami Leon,Elena Rantou,Jessica Kim et al.
Sami Leon et al.
For topical, dermatological drug products, an in vitro option to determine bioequivalence (BE) between test and reference products is recommended. In particular, in vitro permeation test (IVPT) data analysis uses a reference-scaled approach...
Ludwig A Hothorn,Christian Ritz,Frank Schaarschmidt et al.
Ludwig A Hothorn et al.
This tutorial describes single-step low-dimensional simultaneous inference with a focus on the availability of adjusted p values and compatible confidence intervals for more than just the usual mean value comparisons. The basic idea is, fir...
Sample Size Reestimation in Stochastic Curtailment Tests With Time-to-Events Outcome in the Case of Nonproportional Hazards Utilizing Two Weibull Distributions With Unknown Shape Parameters [0.03%]
利用两未知形状参数的威布尔回归模型对非比例风险情况下基于随机截尾终点事件的样本量重新估计方法研究
Palash Sharma,Milind A Phadnis
Palash Sharma
Stochastic curtailment tests for Phase II two-arm trials with time-to-event end points are traditionally performed using the log-rank test. Recent advances in designing time-to-event trials have utilized the Weibull distribution with a know...
Bayesian Predictive Probability Based on a Bivariate Index Vector for Single-Arm Phase II Study With Binary Efficacy and Safety Endpoints [0.03%]
基于二元指标向量的贝叶斯预测概率在单臂二期试验中二元有效性和安全性终点的应用研究
Takuya Yoshimoto,Satoru Shinoda,Kouji Yamamoto et al.
Takuya Yoshimoto et al.
In oncology, Phase II studies are crucial for clinical development plans as such studies identify potent agents with sufficient activity to continue development in the subsequent Phase III trials. Traditionally, Phase II studies are single-...
Tobias Mütze,James Bell,Stefan Englert et al.
Tobias Mütze et al.
The ICH E9(R1) guideline outlines the estimand framework, which aligns planning, design, conduct, analysis, and interpretation of a clinical trial. The benefits and value of using this framework in clinical trials have been outlined in the ...
J C Poythress,Jin Hyung Lee,Kentaro Takeda et al.
J C Poythress et al.
In alignment with the ICH guideline for Good Clinical Practice [ICH E6(R2)], quality tolerance limit (QTL) monitoring has become a standard component of risk-based monitoring of clinical trials by sponsor companies. Parameters that are cand...
A Personalized Dose-Finding Algorithm Based on Adaptive Gaussian Process Regression [0.03%]
一种基于自适应高斯过程回归的个性化剂量寻找算法
Yeonhee Park,Won Chang
Yeonhee Park
Dose-finding studies play a crucial role in drug development by identifying the optimal dose(s) for later studies while considering tolerability. This not only saves time and effort in proceeding with Phase III trials but also improves effi...
Helle Lynggaard,Oliver N Keene,Tobias Mütze et al.
Helle Lynggaard et al.
Most published applications of the estimand framework have focused on superiority trials. However, non-inferiority trials present specific challenges compared to superiority trials. The International Council for Harmonisation of Technical R...
Tutorial on Firth's Logistic Regression Models for Biomarkers in Preclinical Space [0.03%]
Firth逻辑回归模型在生物标志物超低频信号中的应用教程
Gina D&#x;Angelo,Di Ran
Gina D&#x;Angelo
Preclinical studies are broad and can encompass cellular research, animal trials, and small human trials. Preclinical studies tend to be exploratory and have smaller datasets that often consist of biomarker data. Logistic regression is typi...
Lynne B Hare,Stan Altan,Hans Coppenolle
Lynne B Hare
Mixture experimentation is commonly seen in pharmaceutical formulation studies, where the relative proportions of the individual components are modeled for effects on product attributes. The requirement that the sum of the component proport...