Aims: Patient-reported outcomes (PRO) provide a valuable means to assess the subjective impact of a disease and treatment on patients’ symptoms, adverse effects...
Aims: To select a dose for confirmatory trials using prospective simulations based on a PK/PD model of testosterone (T) suppression with the non-peptide gonadot...
This presentation will highlight the importance of understanding and quantitatively integrating the preclinical PK of antibody-drug conjugates (ADCs) to enable ...
Aims: To support the selection of dose combination(s) of solifenacin and mirabegron for further development using a transparent and standardized approach, and t...
Aims: A career in pharmacometrics, biostatistics and computational biology attracts individuals who enjoy working with mathematical equations, data and writing ...
Using some light-hearted ‘stereotypes’ and informal examples, we will explore some fundamental differences between biostatisticians and pharmacometricians in dr...
Aims: The aim of this study is to 1) model the temporal course of tumor size of stage IV gastric cancer patients enrolled into 1st line chemotherapy trials, and...
Aims: Mechanistic viral kinetic (VK) models are increasingly being used to support drug development strategies in the treatment of respiratory virus infection [...
Adult volunteer challenge models are commonly used in a number of infectious diseases, to demonstrate proof of concept for vaccines and large and small molecule...
Aims: Determination of minimum inhibitory concentration (MIC) of antimalarial drugs in the clinical setting may provide a valuable alternative to empirical appr...
Aims: In 2015 the World Health Assembly endorsed the WHO Global Technical Strategy for Malaria 2016-20301, which aims to reduce global malaria incidence and mor...
Aims: Tranversus Abdominal Plane (TAP) blocks are widely used for postoperative analgesia following abdominal surgery. In this block, the local anaesthetic (LA)...
Aims: To evaluate the performance of different pharmacometric and statistical methods of analysis when evaluating power of dose-finding trial designs for treatm...
The cost of drug development has exploded in recent years and risen to a level that soon will no longer be affordable to society. One reason for the high cost o...
Aims: Models for CD4 count and viral load have long been crucial in antiretroviral drug development [1], and have increasingly been used in long-term pharmacome...
Aims: Study protocols for antidiabetic drugs often include withdrawing study participants due to elevated fasting plasma glucose (FPG) and glycosylated hemoglob...
Clinical development standard in Japan has changed over the last decades along with ICH E5 and Japan guidelines (JP GLs; by MHLW, PMDA) that support use of non-...
Aims: Recent break-through and success in oncology including immuno-oncology and combination therapies has generated many excitement. With newer medicines being...
Aims: In pharmacometric analyses, a goal is to quantify the impact of a therapeutic agent on a population of patients with a disease who will take the drug, wit...
Aims From the outset, the aim of pharmacometrics has been to improve patient therapy through model based methods. The focus of these efforts have shifted over t...
Aims: Extensive but fragmented data from existing studies were used to describe the drug-drug interaction between rifabutin and HIV-protease inhibitors, and p...
Aims: The primary aim of this pilot study was to assess the relationship between doxorubicin (dox) and doxorubicinol (doxinol) pharmacokinetics (PK) and markers...