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Author: Stefanie Hennig

2016

An analysis of patient-reported outcomes (PRO) in breast cancer patients through item-response theory (IRT) pharmacometric modeling

Posted on December 10, 2016 by Stefanie Hennig

Aims: Patient-reported outcomes (PRO) provide a valuable means to assess the subjective impact of a disease and treatment on patients’ symptoms, adverse effects...

2016

Optimization of trial design and dose selection based on the quantitative assessment of the efficacy of TAK-385, an investigational, oral GnRH antagonist, in patients with prostate cancer

Posted on December 10, 2016 by Stefanie Hennig

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...

2016

Bench-to-bedside translation of antibody drug conjugates (ADCs) using a multiscale mechanistic PK/PD model

Posted on December 10, 2016 by Stefanie Hennig

This presentation will highlight the importance of understanding and quantitatively integrating the preclinical PK of antibody-drug conjugates (ADCs) to enable ...

2016

Application of a multi-criteria decision analysis model in the dose selection of combination therapy for overactive bladder

Posted on December 10, 2016 by Stefanie Hennig

Aims: To support the selection of dose combination(s) of solifenacin and mirabegron for further development using a transparent and standardized approach, and t...

2016

Pharmacometrics, biostatistics and computational biology postgraduate training: how can we integrate courses?

Posted on December 10, 2016 by Stefanie Hennig

Aims: A career in pharmacometrics, biostatistics and computational biology attracts individuals who enjoy working with mathematical equations, data and writing ...

Uncategorized

Pharmacometricians and statisticians in drug development: can’t we all just get along?

Posted on December 10, 2016 by Stefanie Hennig

Using some light-hearted ‘stereotypes’ and informal examples, we will explore some fundamental differences between biostatisticians and pharmacometricians in dr...

2016

Modeling tumor size and survival in patients with metastatic gastric cancer

Posted on December 10, 2016 by Stefanie Hennig

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...

2018

Challenges and pitfalls of building models for Flu/RSV and respiratory viruses

Posted on December 10, 2016 by Stefanie Hennig

Aims: Mechanistic viral kinetic (VK) models are increasingly being used to support drug development strategies in the treatment of respiratory virus infection [...

2016

Introduction to human challenge models for respiratory viruses and the application of quantitative pharmacology to enhance drug development

Posted on December 10, 2016 by Stefanie Hennig

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...

2016

Pharmacometric modelling of antimalarial drugs in development

Posted on December 10, 2016 by Stefanie Hennig

Aims: Determination of minimum inhibitory concentration (MIC) of antimalarial drugs in the clinical setting may provide a valuable alternative to empirical appr...

2016

Developing next-generation malaria medicines to address drug resistance and increase the operational feasibility of malaria elimination efforts

Posted on December 10, 2016 by Stefanie Hennig

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...

2016

Recommended doses of Levobupivacaine for TAP Blocks: Development of a pharmacokinetic model and estimation of the risk of symptoms of local anesthetic systemic toxicity

Posted on December 10, 2016 by Stefanie Hennig

Aims: Tranversus Abdominal Plane (TAP) blocks are widely used for postoperative analgesia following abdominal surgery. In this block, the local anaesthetic (LA)...

2016

Assessment of pharmacometric and statistical analysis methods in dose-finding trial design: application in diabetes drug development

Posted on December 10, 2016 by Stefanie Hennig

Aims: To evaluate the performance of different pharmacometric and statistical methods of analysis when evaluating power of dose-finding trial designs for treatm...

2016

Why MIC is poison for the mind

Posted on December 10, 2016 by Stefanie Hennig

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...

2016

A simple mechanistic pharmacometric model for HIV in children and adults

Posted on December 10, 2016 by Stefanie Hennig

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...

2016

Population pharmacokinetics and pharmacodynamics of an oral glucagon receptor antagonist (LY2409021) and implications of patient dropout

Posted on December 6, 2016 by Stefanie Hennig

Aims: Study protocols for antidiabetic drugs often include withdrawing study participants due to elevated fasting plasma glucose (FPG) and glycosylated hemoglob...

2016

The importance of body size for bridging studies

Posted on December 6, 2016 by Stefanie Hennig

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-...

2016

Modeling and simulation with evolving cancer therapies: combinations, cancer immunotherapy, and more

Posted on December 5, 2016 by Stefanie Hennig

Aims: Recent break-through and success in oncology including immuno-oncology and combination therapies has generated many excitement. With newer medicines being...

2016

Challenges in treating infectious disease – linking epidemiology with pharmacometrics

Posted on December 5, 2016 by Stefanie Hennig

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...

2016

Big world challenges for pharmacometrics

Posted on November 8, 2016 by Stefanie Hennig

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...

2016

Dose selection for rifabutin in combination with HIV-protease inhibitors

Posted on August 11, 2016 by Stefanie Hennig

  Aims: Extensive but fragmented data from existing studies were used to describe the drug-drug interaction between rifabutin and HIV-protease inhibitors, and p...

2016

A pilot study to investigate the relationship between doxorubicin and doxorubicinol pharmacokinetics and cardiotoxicity in children and adolescents with cancer

Posted on August 11, 2016 by Stefanie Hennig

Aims: The primary aim of this pilot study was to assess the relationship between doxorubicin (dox) and doxorubicinol (doxinol) pharmacokinetics (PK) and markers...

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