Pharmacometrics meets statistics—A synergy for modern drug development
Modern drug development problems are very complex and require integration of various
scientific fields. Traditionally, statistical methods have been the primary tool for design and …
scientific fields. Traditionally, statistical methods have been the primary tool for design and …
Efficient Study Design and Analysis of Longitudinal Dose–Response Data Using Fractional Polynomials
BF Hartley, D Lunn, AP Mander - Pharmaceutical Statistics, 2024 - Wiley Online Library
Correctly characterising the dose–response relationship and taking the correct dose forward
for further study is a critical part of the drug development process. We use optimal design …
for further study is a critical part of the drug development process. We use optimal design …
Comparing randomized trial designs to estimate treatment effect in rare diseases with longitudinal models: a simulation study showcased by Autosomal Recessive …
N Hendrickx, F Mentré, A Hamdan, MO Karlsson… - medRxiv, 2025 - medrxiv.org
Parallel designs with an end-of-treatment analysis are commonly used for randomised trials,
but they remain challenging to conduct in rare diseases due to small sample size and …
but they remain challenging to conduct in rare diseases due to small sample size and …
Improved confidence in a confirmatory stage by application of item-based pharmacometrics model: illustration with a phase III active comparator-controlled trial in …
C Llanos-Paez, C Ambery, S Yang, M Beerahee… - Pharmaceutical …, 2022 - Springer
Purpose The current study aimed to illustrate how a non-linear mixed effect (NLME) model-
based analysis may improve confidence in a Phase III trial through more precise estimates …
based analysis may improve confidence in a Phase III trial through more precise estimates …
Randomization-based Inference for MCP-Mod
Dose selection is critical in pharmaceutical drug development, as it directly impacts
therapeutic efficacy and patient safety of a drug. The Generalized Multiple Comparison …
therapeutic efficacy and patient safety of a drug. The Generalized Multiple Comparison …
Comparison of Seven Non-Linear Mixed Effect Model-Based Approaches to Test for Treatment Effect
E Chasseloup, MO Karlsson - Pharmaceutics, 2023 - mdpi.com
Analyses of longitudinal data with non-linear mixed-effects models (NLMEM) are typically
associated with high power, but sometimes at the cost of inflated type I error. Approaches to …
associated with high power, but sometimes at the cost of inflated type I error. Approaches to …
Pharmacometric-guided optimisation of early clinical decision-making in oncology: Identification of drug effect in clinical drug development and prediction of patient …
Y Nassar - 2024 - refubium.fu-berlin.de
With an estimated 19 million new cancer cases each year and almost 10 million deaths
worldwide, there is a huge need for an optimised development of new therapeutic …
worldwide, there is a huge need for an optimised development of new therapeutic …
Methods for handling model misspecification in pharmacometric model-based approaches for the analysis of longitudinal clinical trial data
E Chasseloup - 2022 - diva-portal.org
Pharmacometrics model-based analyses proved to be increasingly useful in drug discovery
and development. This usefulness was made evident by the formalisation of the model …
and development. This usefulness was made evident by the formalisation of the model …
Effects of online class among parents of school students in Chennai-A questionnaire-based study
I Varshan, R Abilasha - … VOLATILES & ESSENTIAL OILS Journal| NVEO, 2021 - nveo.org
BACKGROUND: In recent times to stop the spread of Coronavirus many Countries all over
the world have implemented lockdown. That brought to a new phase of education which …
the world have implemented lockdown. That brought to a new phase of education which …