Ulrika Simonsson
- Telephone:
- +46 18 471 42 56
- E-mail:
- ulrika.simonsson@uu.se
- Visiting address:
- BMC, Husargatan 3
75124 Uppsala - Postal address:
- Box 591
75124 Uppsala
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Short presentation
Ulrika Simonsson is a professor in pharmacokinetics, leading her own independent research group focusing on pre-clinical to clinical pharmacokinetic-pharmacodynamic translation and its relation to drug development.
Keywords
- antibiotic resistance
- artifical intelligence
- ehealth
- machine learning
- modeling and simulation
- non-linear mixed effects modeling
- pharmacodynamics
- pharmacokinetics
- pharmacometrics
- therapeutic drug monitoring
- translational medicine
- tuberculosis
Biography
Prof Simonsson is a professor of pharmacokinetics at the Department of Pharmaceutical Biosciences at Uppsala University in Sweden. She holds a Masters in Pharmaceutical Sciences, is a licensed pharmacist and obtained a PhD in Pharmaceutical Sciences from Uppsala University in 2000 focusing on pharmacokinetics and pharmacodynamics. She did her post doc work with Pharsight Coperation, CA, USA in 2001-2002 and was on sabbatical leave during 2004-2006 from her faculty position while working as a principal scientist at Astrazeneca. In 2010 she became Associate Professor (docent) and full Professor in Pharmacokinetics in 2016. In 2004 she received the AstraZeneca’s Young Talented Scientist award, in 2007 AstraZenceca’s Clinical Innovation award and in 2011, a Grant for Promotion to Professor from Uppsala University.
Her expertise is focused on how modeling and simulation of pharmacokinetics (PK) and pharmacodynamics (PD) can be used to translate pre-clinical information from in vitro and in vivo to predictions of human exposure and efficacy in order to optimize drug development and for defining individualized dosing.
She has received large EU grants within the field of tuberculosis and was the lead for modeling and simulation in the European IMI funded consortium Predict-TB. She has supervised 15 students to their Ph.D., six of these as the main supervisor. Ulrika has acted as an international opponent at two doctoral theses, has published more than 90 peer-reviewed research articles and is routinely giving training to academia and industry. She has almost 25 years of experience as a pharmacometric external consultant to many drug development companies including regulatory interactions and filing. She has been the pharmacometric lead on two successful registrations and several Phase III filings. Her research and consultancy activities have included several different therapeutic areas such as malaria, tuberculosis, HIV, thrombosis/cardiovascular diseases, diabetes, insomnia, prostate cancer, hypertension, asthma and cortisol insufficiency. She has an extensive hands-on experience in modeling complex PKPD and disease models.
Research
Professor Simonsson's research profile is presented at
Publications
Recent publications
- Evaluation of critical parameters in the hollow‐fibre system for tuberculosis (2024)
- Model-based interspecies scaling for predicting human pharmacokinetics of CB 4332, a complement factor I protein (2024)
- Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors (2024)
- A noninvasive BCG skin challenge model for assessing tuberculosis vaccine efficacy (2024)
- Risk Factors for COVID-19 and Respiratory Tract Infections during the Coronavirus Pandemic (2024)
All publications
Articles
- Evaluation of critical parameters in the hollow‐fibre system for tuberculosis (2024)
- Model-based interspecies scaling for predicting human pharmacokinetics of CB 4332, a complement factor I protein (2024)
- Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors (2024)
- A noninvasive BCG skin challenge model for assessing tuberculosis vaccine efficacy (2024)
- Risk Factors for COVID-19 and Respiratory Tract Infections during the Coronavirus Pandemic (2024)
- Combined quantitative tuberculosis biomarker model for time-to-positivity and colony forming unit to support tuberculosis drug development (2023)
- Model-Informed Support of Dose Selection for Prophylactic Treatment with Dalcinonacog Alfa in Adult and Paediatric Hemophilia B Patients (2023)
- Model-informed pediatric dose selection of marzeptacog alfa (activated) (2023)
- Cough as Noninvasive Biomarker for Monitoring Tuberculosis Treatment (2023)
- Derivation and Clinical Utility of Safety Targets for Linezolid-Related Adverse Events in Drug-Resistant Tuberculosis Treatment (2023)
- Early bactericidal activity studies for pulmonary tuberculosis (2023)
- Standards for model-based early bactericidal activity analysis and sample size determination in tuberculosis drug development (2023)
- Clinical standards for the management of adverse effects during treatment for TB (2023)
- Model-based analysis of bactericidal activity and a new dosing strategy for optimised-dose rifampicin (2023)
- Implementing best practices on data generation and reporting of Mycobacterium tuberculosis in vitro assays within the ERA4TB consortium (2023)
- Seasonal influence on respiratory tract infection severity including COVID-19 quantified through Markov Chain modeling (2023)
- Reproducibility in pharmacometrics applied in a phase III trial of BCG-vaccination for COVID-19 (2023)
- Pharmacokinetics and pharmacodynamics of anti-tuberculosis drugs (2022)
- Early Bactericidal Activity of Meropenem plus Clavulanate (with or without Rifampin) for Tuberculosis (2022)
- Safety and pharmacokinetics-pharmacodynamics of a shorter tuberculosis treatment with high-dose pyrazinamide and rifampicin (2022)
- Phase III dose selection of marzeptacog alfa (activated) informed by population pharmacokinetic modeling (2022)
- A modeling-based proposal for safe and efficacious reintroduction of bedaquiline after dose interruption (2022)
- Machine Learning and Pharmacometrics for Prediction of Pharmacokinetic Data (2022)
- Model-Informed Precision Dosing of Linezolid in Patients with Drug-Resistant Tuberculosis (2022)
- Predictive Modeling to Study the Treatment-Shortening Potential of Novel Tuberculosis Drug Regimens, Toward Bundling of Preclinical Data (2022)
- Standard therapy of Mycobacterium avium complex pulmonary disease shows limited efficacy in an open source hollow fibre system that simulates human plasma and epithelial lining fluid pharmacokinetics (2022)
- Study protocol for locoregional precision treatment of hepatocellular carcinoma with transarterial chemoembolisation (TACTida), a clinical study (2022)
- Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers (2022)
- Finding the right hazard function for time-to-event modeling (2022)
- Pharmacometrics in tuberculosis (2022)
- Suboptimal moxifloxacin and levofloxacin drug exposure during treatment of patients with multidrug-resistant tuberculosis (2021)
- Superior Efficacy of a Bedaquiline, Delamanid, and Linezolid Combination Regimen in a Mouse Tuberculosis Model (2021)
- A model-based analysis identifies differences in phenotypic resistance between in vitro and in vivo (2020)
- Difference in persistent tuberculosis bacteria between in vitro and sputum from patients (2020)
- Drug Effect of Clofazimine on Persisters Explains an Unexpected Increase in Bacterial Load in Patients (2020)
- Transforming Translation Through Quantitative Pharmacology for High-Impact Decision Making in Drug Discovery and Development (2020)
- Medical Device Apps (2020)
- Individualized Dosing With High Inter-Occasion Variability Is Correctly Handled With Model-Informed Precision Dosing (2020)
- Mobile Health Apps for Improvement of Tuberculosis Treatment (2020)
- Rotational thromboelastometry can predict the probability of bleeding events in a translational rat model of haemophilia A following gene-based FVIIa prophylaxis (2020)
- Translational Model-Informed Approach for Selection of Tuberculosis Drug Combination Regimens in Early Clinical Development. (2020)
- Rifampicin can be given as flat-dosing instead of weight-band dosing (2020)
- Model-informed drug discovery and development strategy for the rapid development of anti-tuberculosis drug combinations (2020)
- Anti‐tuberculosis effect of isoniazid scales accurately from zebrafish to humans (2020)
- Quantification of Natural Growth of Two Strains of Mycobacterium Marinum for Translational Antituberculosis Drug Development (2020)
- Individualised dosing algorithm and personalised treatment of high‐dose rifampicin for tuberculosis (2019)
- Model-Based Relationship between the Molecular Bacterial Load Assay and Time to Positivity in Liquid Culture (2019)
- Consider ASCPT in Your End-of-Year Giving (2019)
- Comparisons of analysis methods for assessment of pharmacodynamic interactions including design recommendations (2018)
- A model-informed preclinical approach for prediction of clinical pharmacodynamic interactions of anti-TB drug combinations (2018)
- Plasma concentrations of second-line antituberculosis drugs in relation to minimum inhibitory concentrations in multidrug-resistant tuberculosis patients in China (2018)
- Prediction of human pharmacokinetics of activated recombinant factor VII and B-domain truncated factor VIII from animal population pharmacokinetic models of haemophilia (2018)
- Impact of trial design on the estimation of drug potency and power in clinical trials of haemophilia with inhibitors (2018)
- Improving treatment outcome assessment in a mouse tuberculosis model (2018)
- Distribution of plasma concentrations of first-line anti-TB drugs and individual MICs (2018)
- The Potential for Treatment Shortening With Higher Rifampicin Doses (2018)
- A Population Pharmacokinetic Model Incorporating Saturable Pharmacokinetics and Autoinduction for High Rifampicin Doses (2018)
- Greater Early Bactericidal Activity at Higher Rifampicin Doses Revealed by Modeling and Clinical Trial Simulations (2018)
- Forecasting Clinical Dose-Response From Preclinical Studies in Tuberculosis Research (2018)
- The multistate tuberculosis pharmacometric model (2017)
- Assessing Pharmacodynamic Interactions in Mice using the Multistate Tuberculosis Pharmacometric and General Pharmacodynamic Interaction Models (2017)
- Analysis of opioid consumption in clinical trials (2017)
- The implications of model-informed drug discovery and development for tuberculosis (2017)
- Residual Spinal Cord Compression Following Hemilaminectomy and Mini-Hemilaminectomy in Dogs (2017)
- Improved power for TB Phase IIa trials using a model-based pharmacokinetic-pharmacodynamic approach compared with commonly used analysis methods (2017)
- A general pharmacodynamic interaction model identifies perpetrators and victims in drug interactions (2017)
- Population pharmacokinetics, optimised design and sample size determination for rifampicin, isoniazid, ethambutol and pyrazinamide in the mouse (2016)
- A multistate tuberculosis pharmacometric model (2016)
- A Pharmacokinetic-Pharmacodynamic Model of Morphine Exposure and Subsequent Morphine Consumption in Postoperative Pain (2016)
- Population Pharmacokinetics of Edoxaban in Patients with Non-Valvular Atrial Fibrillation in the ENGAGE AF-TIMI 48 Study, a Phase III Clinical Trial (2016)
- Edoxaban Exposure-Response Analysis and Clinical Utility Index Assessment in Patients With Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism (2016)
- Application of the Multistate Tuberculosis Pharmacometric Model in Patients With Rifampicin-Treated Pulmonary Tuberculosis (2016)
- A Recirculatory Model for Pharmacokinetics and the Effects on Bispectral Index After Intravenous Infusion of the Sedative and Anesthetic AZD3043 in Healthy Volunteers (2015)
- Performance of Nonlinear Mixed Effects Models in the Presence of Informative Dropout (2015)
- Population pharmacokinetics of morphine and morphine-6-glucuronide following rectal administration - A dose escalation study (2015)
- A pharmacometric pulmonary model predicting the extent and rate of distribution from plasma to epithelial lining fluid and alveolar cells-using rifampicin as an example (2015)
- Evaluation of optimized bronchoalveolar lavage sampling designs for characterization of pulmonary drug distribution (2015)
- Repeated Time-to-event Analysis of Consecutive Analgesic Events in Postoperative Pain (2015)
- Population pharmacokinetics of edoxaban and its main metabolite in a dedicated renal impairment study (2015)
- Population pharmacokinetics of edoxaban in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism-the Hokusai-VTE phase 3 study (2015)
- Intra- and Extracellular Activities of Trimethoprim-Sulfamethoxazole against Susceptible and Multidrug-Resistant Mycobacterium tuberculosis (2014)
- Population pharmacokinetics of rifampicin, pyrazinamide and isoniazid in children with tuberculosis (2014)
- Moxifloxacin Population Pharmacokinetics and Model-Based Comparison of Efficacy between Moxifloxacin and Ofloxacin in African Patients (2014)
- A Model Predicting Penetration of Rifampicin from Plasma to Epithelial Lining Fluid and Alveolar Cells (2013)
- D Optimal Designs for Three Poisson Dose-Response Models (2013)
- Model based design and analysis of phase II HIV-1 trials (2013)
- Evaluation of Initial and Steady-State Gatifloxacin Pharmacokinetics and Dose in Pulmonary Tuberculosis Patients by Using Monte Carlo Simulations (2013)
- A Semimechanistic Pharmacokinetic-Enzyme Turnover Model for Rifampin Autoinduction in Adult Tuberculosis Patients (2012)
- Model-based approach to dose optimization of lopinavir/ritonavir when co-administered with rifampicin (2012)
- Population pharmacokinetics of lopinavir and ritonavir in combination with rifampicin-based antitubercular treatment in HIV-infected children (2012)
- Moxifloxacin Population Pharmacokinetics in Patients with Pulmonary Tuberculosis and the Effect of Intermittent High-Dose Rifapentine (2012)
- Modelling of pain intensity and informative dropout in a dental pain model after naproxcinod, naproxen and placebo administration (2011)
- Population Pharmacokinetics of Ethambutol in South African Tuberculosis Patients (2011)
- Non-linear mixed effects modeling of antiretroviral drug response after administration of lopinavir, atazanavir and efavirenz containing regimens to treatment-naïve HIV-1 infected patients. (2011)
- Variability in the population pharmacokinetics of isoniazid in South African tuberculosis patients (2011)
- A two-compartment effect site model describes the bispectral index after different rates of propofol infusion (2010)
- Population pharmacokinetics of lopinavir in combination with rifampicin-based antitubercular treatment in HIV-infected South African children (2010)
- An example of optimal phase II design for exposure response modelling (2010)
- Effects of Four Different Meal Types on the Population Pharmacokinetics of Single-Dose Rifapentine in Healthy Male Volunteers (2010)
- Population pharmacokinetics of nevirapine in combination with rifampicin-based short course chemotherapy in HIV- and tuberculosis-infected South African patients (2009)
- Blood–Brain Barrier Transport Helps to Explain Discrepancies in In Vivo Potency between Oxycodone and Morphine (2008)
- A model based assessment of the CYP2B6 and CYP2C19 inductive properties by artemisinin antimalarials (2008)
- Population Pharmacokinetics of Rifampin in Pulmonary Tuberculosis Patients Including a Semi-mechanistic Model to Describe Variable Absorption (2008)
- Artemisinin antimalarials moderately affect cytochrome P450 enzyme activity in healthy subjects. (2007)
- An integrated glucose-insulin model to describe oral glucose tolerance test data in type 2 diabetics (2007)
- Optimal adaptive design in clinical drug development (2007)
- An integrated model for glucose and insulin regulation in healthy volunteers and type 2 diabetic patients following intravenous glucose provocations (2007)
- In Vivo Blood-Brain Barrier Transport of Oxycodone in the Rat (2006)
- Enantiospecific separation and quantitation of mephenytoin and its metabolites nirvanol and 4'-hydroxymephenytoin in human plasma and urine by liquid chromatography/tandem mass spectrometry (2006)
- In vivo and mechanistic evidence of nuclear receptor CAR induction by artemisinin (2006)
- Variability in the population pharmacokinetics of pyrazinamide in South African tuberculosis patients (2006)
- Pharmacokinetics of Desmopressin Administrated as an Oral Lyophilisate Dosage Form in Children With Primary Nocturnal Enuresis and Healthy Adults (2006)
- Oxycodone Pharmacokinetics and Pharmacodynamics in the Rat in the Presence of the P-Glycoprotein Inhibitor PSC833 (2005)
- Population pharmacokinetics of rifapentine and its primary desacetyl metabolite in South African tuberculosis patients (2005)
- The Use of Liquid Chromatography/Mass Spectrometry for Quantitative Analysis of Oxycodone, Oxymorphone and Noroxycodone in Ringer Solution, Rat Plasma and Rat Brain Tissue (2004)
- Simultaneous enantiospecific separation and quantitation of mephenytoin and its metabolites nirvanol and 4'-hydroxymephenytoin in human plasma by liquid chromatography (2003)
- Artemisinin autoinduction is caused by involvement of cytochrome P450 2B6 but not 2C9 (2003)
- Characterisation of the human liver in vitro metabolic pattern of artemisinin and auto-induction in the rat by use of nonlinear mixed effects modelling. (2003)
- Population pharmacokinetic and pharmacodynamic modelling of artemisinin and mefloquine enantiomers in patients with falciparum malaria. (2002)
- In vitro evidence for auto-induction of artemisinin metabolism in the rat (2001)
- Quantitative in vivo and in vitro sex differences in artemisinin metabolism in rat (1999)
- A mechanism-based pharmacokinetic-enzyme model for cyclophosphamide autoinduction in breast cancer patients (1999)
- Stereospecific analysis of omeprazole supports artemisinin as a potent inducer of CYP2C19 (1999)
- Identification of the human cytochrome P450 enzymes involved in the in vitro metabolism of artemisinin (1999)
- High in situ rat intestinal permeability of artemisinin unaffected by multiple dosing and with no evidence of P-glycoprotein involvement (1999)
- High in situ rat intestinal permeability of artemisinin unaffected bymultiple dosing and with no evidence of P-glycoprotein involvement (1999)
- Artemisinin induces omeprazole metabolism in human beings (1998)
- Model-based effect evaluation of a novel Mmpl3 inhibitor in C3HeB/FeJ compared to BALB/c mouse models and translation to humans
- A model informed pre-clinical approach for identification of exposure-response and pharmacodynamic interactions in early tuberculosis drug development
- Model-based approaches to prospectively power pediatric pharmacokinetic trials with limited sample size
- Drug effect of clofazimine on persisters explain an unexpected increase in bacterial load from patients
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