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PhD Research Project: Development of in vitro, in silico knowledge & tools to ensure appropriate pa

Employer
Global Academy Jobs
Location
United Kingdom
Closing date
Jan 31, 2017

Job Details

Details

Development of age-appropriate paediatric medicines take the same development resources as their adult counterparts yet the market is typically much smaller; therefore efforts are required to ensure the development of paediatric formulations is lean. The lack of guidance on labelling for paediatric products co-administered with food can lead to extensive testing. There is an opportunity to design a pathway to better understand and therefore predict the clinical risks associated with co-administration of food.

The lack of knowledge in paediatric biopharmaceutics due to the complexity in characterizing peadiatric gastrointestinal anatomy and physiology, plus the very limited pharmacokinetic data available has been well documented. The OrBiTo project sought to develop fundamental knowledge of the adult gastrointestinal environment yet paediatric populations were excluded. There is a real need to obtain key information about the paediatric GI tract (neonates to aged 12) which will be used to develop appropriate in vitro and in silico models to better predict the performance of paediatric products.

This project will characterize the gastrointestinal tract of children (with a focus on the “healthy GI tract”) with regard to fluid volumes, distribution and composition, transit time and the quantification of specific transporters on the intestinal tissue. The University will obtain access to images (Ultrasound, computer tomography, positron emission tomography, magnetic resonance imaging and Nuclear Medicine) from children who require gastro-intestinal imaging as part of their routine clinical care. From these images information on fluid volume and localization within the GI tract will be extracted. In addition, the University will recruit children with indwelling nasogastric, nasoduodenal or nasojejunal tubes to a study to enable withdrawal of small amount of resident intestinal fluid. These fluids will be characterized as completely as possible including osmolality, pH, bile salt concentration and viscosity. The University will also collect intestinal tissue from children having surgery and characterize the intestinal tissues for the presence of transporters. Alternatively endoscopy/colonoscopy can be considered for fluid collection, as this technique is suitable for neonates through to children aged 12. The data collected from the imaging and characterization of fluids and tissue will be fed into SimCYP to develop models giving a better prediction of drug behaviour in the paediatric population together with Population PK analyses to help capture/determine the ’real’ observed variability in some of the parameters.

This project will require an individual with knowledge about formulated medicinal products, specifically those designed for children as well as biopharmaceutics of drug products. The individual will be required to characterise GI fluids. All the equipment required is available within the pharmacy department at the University of Birmingham. Full training will be provided on this equipment.

Applications are invited for a 3-year fully-funded PhD Studentship starting between April and May 2017.

Person Specification
The ideal candidate will have a strong interest biopharmaceutics research; be enthusiastic about the development of age-appropriate medicines for children; be confident in working in the laboratory and possess clear communication skills. Applicants should have a strong background in pharmaceutical formulation or science. They should have a commitment to paediatric research and hold or realistically expect to obtain at least an Upper Second Class Honours Degree in a relevant subject (preferably in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or Engineering) relevant and recent experience of ethical approval processes is desirable.

This studentship will cover the University tuition fees and stipend for up to three years for British/EU citizens. Applications will be accepted until the 31st January 2017; however, the post will be filled as soon as a suitable candidate is found. The starting date can be between April and May 2017.

How to apply
Informal enquiries should be directed to Dr Hannah Batchelor (h.k.batchelor@bham.ac.uk)

Applications should be directed to Viktorija Ziabliceva (v.ziabliceva@bham.ac.uk). To apply, please send:
• A detailed CV, including your nationality and country of birth;
• Names and addresses of two referees;
• A covering letter highlighting your research experience/capabilities;
• Copies of your degree certificates with transcripts;
• Evidence of your proficiency in the English language, if applicable.

Funding Notes

British and EU nationality applicants are eligible for both the cost of tuition fees and a yearly stipend (at RCUK rate) over the course of the PhD programme.

References

1. H K Batchelor, N Fotaki and S Klein. (2014) Paediatric Biopharmaceutics. Advanced Drug Delivery Reviews. 73: 102-126 http://dx.doi.org/10.1016/j.addr.2013.10.006
2. H K Batchelor. (2015) Influence of food on paediatric gastrointestinal drug absorption following oral administration: a review. Children (2015) 2:244-271 doi:10.3390/children2020244
3. H K Batchelor and J F Marriott. (2015). Paediatric pharmacokinetics: key considerations. British Journal of Clinical Pharmacology. 79(3):395-404 DOI: 10.1111/bcp.12267 (IF = 3.58)
4. H K Batchelor, R Appleton, D B Hawcutt. (2015) Comparing paediatric intravenous phenytoin doses using physiologically based pharmacokinetic (PBPK) modelling software. Seizure. 2015 Dec;33:8-12. doi: 10.1016/j.seizure.2015.10.006

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