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 ...
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...
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...
Application of a quantitative systems pharmacology (QSP) model to evaluate xCT inhibition as a target for central nervous system diseases. Aims: Neuronal exci...
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: Existing evidence from clinical trial data suggests that a positive placebo effect occurs in overactive bladder (OAB) patients (1). Researchers also confi...
Aims: Physiologic changes due to disease status can lead to highly variable pharmacokinetics (PK) of amikacin in children. Therefore, considerations should be g...
Aims: The property of a drug that signifies the likelihood of therapeutic success to imperfect adherence is termed forgiveness. Recently forgiveness has been qu...
Aims: Infections involving hypermutable Pseudomonas aeruginosa (Pa) are highly problematic due to their enhanced resistance emergence. For aminoglycosides suc...
Aims: The in vivo performance of single-unit (“tablet/capsule”) and multiple-units (“pellets, multi-tablets”) dosage forms may sometime be markedly influenced b...
Aims: The oral bioavailability of drugs is influenced by a many factors including the regional gastrointestinal (GI) pH. Small changes in the GI pH profile may ...
Aims: Artemisinin-based combination therapies are the recommended first-line treatment for falciparum malaria. Artemisinin derivatives, containing the peroxide ...
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: Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for inflammatory bowel disease. The aims of this analysis were to...
Aims: Tanezumab is a monoclonal lgG antibody targeted against nerve growth factor (NGF). It is currently under clinical development for the treatment of chronic...
Aims: The National Kidney Foundation guidelines recommend the use of equations to estimate glomerular filtration rate (GFR) in paediatrics and adults, some of w...
Aims: To describe the population pharmacokinetics of gentamicin in paediatric febrile neutropenic patients and to identify covariates which explain pharmacokine...
Aims: It is usually more difficult to build a PK-PD model with discrete symptomatic disease endpoints than a PK-PD model with continuous biomarkers because a ...
Introduction: Levofloxacin is used to treat a wide variety of bacterial infections. Levofloxacin belongs to a class of drugs called quinolone antibiotics. It wo...
Aims: Pegylated interferon alfa-2a is an antiviral drug approved for the treatment of chronic hepatitic B and C. The addition of polyethylene glycol (pegylation...
Aims: The Drug Disease Model Resources (DDMoRe, http://www.ddmore.eu/) consortium was created to improve the quality, efficiency and cost effectiveness of Model...
Background: Dosing of prophylactic antibiotics in children during cardiopulmonary bypass (CPB) remains poorly defined. Pharmacokinetic (PK) studies can be impro...
Aims: To describe the hazard of having Aspergillus fumigatus positive cultures in young children (≤ 5 years of age) with cystic fibrosis (CF) and to investigate...
Aims: With the development of common language standards, an interoperability framework and a library of (certified) models the DDMoRe project makes the use of m...
Aims: DDMoRe is a consortium of European Federation of Pharmaceutical Industries and Associations (EFPIA), Academic and Small Medium Enterprise (SME) partners f...
Aims: Thrombocytopenia and anemia are among the most important adverse effects of linezolid treatment. Linezolid-induced thrombocytopenia incidence varies consi...
Aims: Parameter variability in a model can be described as an explained parameter variability with covariates (EPV) and unexplained parameter variability (UPV) ...
Aims: Warfarin is the anticoagulant of choice for venous thromboembolism treatment. However, its suppression of the endogenous clot dissolution components PC an...
Aims: ADVAN-style analytical solutions for 1, 2, 3 compartment linear pharmacokinetic models of intravenous bolus, infusion, and first-order absorption have bee...
Aims: Respiratory syncytial virus (RSV) causes acute respiratory tract infections, and is a major cause of hospital admissions and death in young children world...
Aims: Recently the FDA approved the first two drugs (pirfenidone and nintedanib) indicated for the treatment of idiopathic pulmonary fibrosis (IPF), a therapeut...
Aims: The design of full development trials requires a number of features to be defined. Those include the population, treatment regimen, endpoint with clinical...
DDMoRe, Drug Disease Model Resources, (http://www.ddmore.eu/) is an European project founded by the IMI and EFPIA, which aims to improve efficiency in the proce...
Aims: Artemisinin-resistant falciparum malaria is now prevalent in Southeast Asia. Understanding the pharmacokinetic and pharmacodynamic properties of artesunat...
Aims: LCB01-0371 is a new oxazolidinone antibiotic with cyclic amidrazone under clinical development. It exerts its anti-bacterial activity by binding to bacter...
Aims: Tamoxifen is a prodrug, and active metabolites including endoxifen are known to exert its therapeutic effect of tamoxifen. Tamoxifen is converted to endox...
Aims: Ivabradine, a selective inhibitor of the pacemaker current (If), is used for heart failure and coronary heart disease, and mainly metabolized to S18982 (1...
Aims: Donepezil is a well-known reversible noncompetitive acetylcholinesterase inhibitor for the symptomatic treatment of Alzheimer’s disease (AD). The purpose ...
Aims: Trastuzumab is a monoclonal antibody that is mainly used to treat breast cancer and exerts its therapeutic effect by inhibiting the HER2/neu receptor. The...
Aims: GCC-4401C, an orally active direct factor Xa inhibitor which is similar to rivaroxaban, is currently under development for venous thromboembolic disease. ...
Aims: Pregabalin, an anticonvulsant drug and duloxetine, a selective serotonin-norepinephrine reuptake inhibitor (SNRI) are used for pain relief. The purpose of...
Aims: Identifiability is an important component of model development. An identifiability analysis can provide the basis for understanding the limits of model st...
Aims: Hyper-acute, mass occurrence of events (e.g., at day 0~1) is not rare in biomedical data. If the event times are recorded on a daily basis in such situati...
Aims: This study aims to develop a mechanism-based model of calcium treatment effect in calcium-parathyroid hormone (PTH) homeostasis after thyroidectomy in Kor...
Aims: This study aims to develop a quantitative semi-mechanistic model to describe the disease progression of leukemia during chemotherapy using circulating bio...
Aims: The most commonly used methods for defining the dose rationale during early stage drug development i.e. pairwise comparison of different doses have shown ...
Aims: Pharmacogenetics (PG) studies the relationship between genetic variation and drug response with the aim of providing more precision to the development of ...
Aims: To produce a viral kinetic (VK) model of Cytomegalovirus (CMV) that predicts changes in viral load within an individual as the infection responds to antiv...
Aims: The overarching aim of the NextDose project is to bring better dosing methods to the ward with target concentration intervention software. This includes t...
Aims: Haematopoietic stem cell transplantation (HSCT) is a vital therapy that is used to cure high-risk or relapsed malignant and nonmalignant conditions. Busul...
Aims: The treat-to-target approach in the management of rheumatoid arthritis (RA) involves frequent assessments of disease activity (measured by the 28-joint di...
Aims: To develop a software tool with the ability to rapidly compare Non-Compartmental Analysis (NCA) and Non-Linear Mixed-Effect Modelling (NLMEM) methods in d...
Aims: nlmixr is an open-source R package under development that builds on both RxODE1, an R package for simulation of nonlinear mixed effect models using ordina...
Aims: Both the Integrated Glucose Insulin model (IGI) and the Integrated Minimal Model (IMM) have been proposed to characterize simultaneously glucose-insulin r...
Aims: To determine the pharmacokinetic parameters of levetiracetam (LEV), a third-generation antiepileptic drug, and its metabolite, etiracetam carboxylic acid ...
Road to individualising tacrolimus therapy in solid organ transplant recipients Christine E. Staatz1 1University of Queensland, School of Pharmacy, Brisbane, QL...
Aims: guide the dose finding in clinical studies based on the Induced Blood Stage Malaria (IBSM) challenge studies and population pharmacokinetic-pharmacodynami...
Aims: Fat free mass (FFM) describes the non-fat component of the body. It has been advocated as an appropriate size descriptor to scale drug clearance (CL) and ...
Aims: Warfarin acts by inhibiting the reduction of vitamin K (VK) to its active form, thereby decreasing the production of VK-dependent coagulation factors. The...
Background: Understanding disease progression, drug and placebo effects, as well as drop-outs in Alzheimer’s disease (AD) studies is critical in order to ...
Aims: Optimize the dosing regimen for an antibody-based therapy of psoriasis using Phase 1 and 2 data. Methods: Optimizing dosing regimens is challenging in...
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: We discuss the question of model identifiability within the context of nonlinear mixed effects models and application to pharmacokinetic models. Methods: ...
Aims: To facilitate model communication and evaluation through intuitive visual representation of their structure, parameter values and uncertainty. Methods: An...
Aims: The primary aim of this pilot study was to assess the relationship between doxorubicin (dox) and doxorubicinol (doxinol) pharmacokinetics (PK) and markers...
Aims: Allometry is the study of how body size is related to body function. In clinical medicine, size related differences in biological functions such as hea...