PhD Studentship in Pharmacometrics at The University of Manchester, Manchester UK

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http://www.findaphd.com/search/ProjectDetails.aspx?PJID=67654&LID=1030 Development of a precision dosing tool for simvastatin treatment in children and adolescents with dyslipidaemias Project Description Dyslipidaemia is an important etiologic factor in the development of cardiovascular disease. Simvastatin is a HMG-CoA reductase inhibitor, commonly used to treat lipid disorders and reduce the probability of a cardiovascular event. Simvastatin is administered as a lactone and requires conversion to simvastatin acid to become therapeutically active. Its complex pharmacokinetics is associated with inter-conversion between lactone-acid forms and affected by multiple metabolic enzymes (CYP3A4) and transporters (OATP1B1, BCRP). The objective of this project is to develop a mechanistic population PBPK model for simvastatin lactone and acid in children/adolescents with dyslipidaemia. The model will allow prediction of simvastatin concentration profiles in liver (efficacy) and muscle (toxicity) in this patient population group. Although widely used in adults, guidance on the individual dosage regimen of simvastatin in children and adolescents with dyslipidaemia is lacking. Mechanistic model that describes accurately complex simvastatin pharmacokinetics in children is essential as a precision dosing tool that would also minimise the risk of muscle toxicity (the most serious adverse effect). Model development will be based on our published mechanistic simvastatin model in adults and will account for physiological differences between populations and ontogeny of transporters/enzymes of relevance. Plasma concentrations of simvastatin acid and lactone measured in children/young adults will be analysed simultaneously with nonlinear mixed effect modelling approach in NONMEM. Clinical data will be provided from our collaborator at Children's Mercy Hospital and Clinics, University of Missouri, Kansas City. Information on patients' age, body mass index, LDL level and OATP1B1 genotype will be considered as covariates in the model development. Mevalonate will be measured in plasma samples as a biomarker of HMG-CoA reductase inhibition to allow comparison of pharmacodynamic effect in children relative to adults. The modelling aspects of this project have strong foundations and build upon previous and ongoing research in our group. This 3.5-year full-time MRC DTP studentship provides full support for tuition fees, annual tax-free stipend at Research Council UK rates (currently £14, 057) and conference/travel allowance. The project is due to commence October 2016 and is open to UK/EU nationals only due to the nature of the funding. The successful candidate will receive training in a wide range of research skills including quantitative techniques such as modelling and simulation. Applicants should hold (or be expected to obtain) a minimum upper-second class undergraduate degree in a related area. A relevant Masters degree or equivalent research experience would be an advantage. Any queries regarding the suitability of qualifications should be directed to the primary supervisor Please direct applications in the following format to Dr Kayode Ogungbenro ([email protected]): * Academic CV * Official academic transcripts * Contact details for two suitable referees * A personal statement (750 words maximum) outlining your suitability for the study, what you hope to achieve from the PhD and your research experience to date. Any enquiries relating to the project and/or suitability should be directed to Dr Ogungbenro. Applications are invited up to and including 25 November 2015. Further details on the MRC DTP scheme and additional PhD project opportunities can be found on our website: http://www.mhs.manchester.ac.uk/mrcdtp http://www.pharmacy.manchester.ac.uk/staff/18015 Kay Kayode Ogungbenro, PhD Lecturer in Cancer Pharmacometrics | Manchester Pharmacy School | The University of Manchester | Manchester M13 9PT | United Kingdom Tel : + 44(0)161 275 2399 Fax: +44(0)161 275 8349 Email: [email protected]<mailto:[email protected]> Web: http://www.pharmacy.manchester.ac.uk/staff/18015