[PDF][PDF] Unlocking Dithranol's Potential: Advanced Drug Delivery Systems for Improved Pharmacokinetics

P Kumar, KK Savita, A Dubey… - Int. J. Drug Deliv. Technol, 2024 - researchgate.net
Dithranol is a therapeutic agent mainly used for psoriasis; however, its clinical use is limited
by poor stability, skin irritation, and low patient compliance with conventional formulations …

Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial …

L Richert, A Doussau, JD Lelièvre, V Arnold, V Rieux… - Trials, 2014 - Springer
Background Many candidate vaccine strategies against human immunodeficiency virus
(HIV) infection are under study, but their clinical development is lengthy and iterative. To …

Bayesian predictive monitoring with bivariate binary outcomes in phase II clinical trials

V Sambucini - Computational Statistics & Data Analysis, 2019 - Elsevier
Traditionally, phase II single-arm trials are based on a binary response variable that
represents the efficacy of the experimental treatment. However, the introduction of an …

Bayesian Predictive Probability Based on a Bivariate Index Vector for Single‐Arm Phase II Study With Binary Efficacy and Safety Endpoints

T Yoshimoto, S Shinoda, K Yamamoto… - Pharmaceutical …, 2024 - Wiley Online Library
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 …

Efficacy and toxicity monitoring via Bayesian predictive probabilities in phase II clinical trials

V Sambucini - Statistical Methods & Applications, 2021 - Springer
Bayesian monitoring strategies based on predictive probabilities are widely used in phase II
clinical trials that involve a single efficacy binary variable. The essential idea is to control the …

An extension of Bayesian predictive sample size selection designs for monitoring efficacy and safety

S Teramukai, T Daimon, S Zohar - Statistics in Medicine, 2015 - Wiley Online Library
Most exploratory clinical trials in cancer are designed as single‐arm trials using a binary
efficacy outcome with or without interim monitoring. In this context, we have proposed a …

A phase II clinical trial design for associated co-primary efficacy and toxicity outcomes with baseline covariates

K Brock, L Billingham, C Yap, G Middleton - … 2018, Warwick, UK, July 2-3 …, 2019 - Springer
The experimental design presented here is motivated by a phase II clinical trial called
PePS2, investigating the efficacy and safety of an immunotherapy called pembrolizumab in …

Methods to increase efficiency in clinical trials with restricted sample size

K Brock - 2019 - etheses.bham.ac.uk
Efficiency is a perennial motivation of statistical analysis and clinical trials. This is most
pertinent when sample size is constrained. When trials and their analyses are more efficient …

Comments on 'Application of an adaptive design to a randomized phase II selection trial in gastric cancer: a report of the study design'by Satoshi Morita and Junichi …

MM Hossain, Z Chen - Pharmaceutical Statistics, 2012 - Wiley Online Library
Comments on ‘Application of an adaptive design to a randomized phase II selection trial in
gastric cancer: a report of the study design’ by Satoshi Morita and Junichi Sakamoto …

Predictive control of posterior robustness for sample size choice in a Bernoulli model

F De Santis, MC Fasciolo, S Gubbiotti - Statistical Methods & Applications, 2013 - Springer
In this article we consider the sample size determination problem in the context of robust
Bayesian parameter estimation of the Bernoulli model. Following a robust approach, we …