Determination of the lipid composition of human tissues for PBPK model
Research type
Research Study
Full title
Determination of the lipid composition of human tissues for physiologically-based pharmacokinetic models v1.
IRAS ID
256575
Contact name
David Hallifax
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 9 months, 17 days
Research summary
Physiologically-based pharmacokinetic (PBPK) models are used by pharmaceutical companies and regulators in making predictions and decisions about how a drug will act in the body, whether that person is healthy or has an underlying disease that may affect drug action, and what adjustments to dosing may be required as a result. Current, state of the art predictions of how a new drug will distribute throughout the body rely on tissue composition data, including detailed lipid composition data which is lacking in availability in the literature.
This study will determine the lipid composition for three critical tissues in the prediction of distribution, liver, adipose and muscle. Since human tissue is difficult to obtain, and the cost implications for analysis, three donors will be used for each tissue, with comparisons then drawn from the limited existing data. The tissues will be provided by a US supplier, BioIVT, that collects tissues for research from the deceased, and imported for analysis.In order to have confidence in the results of the lipid analysis, the lipid composition will be outsources and determined using well-established chromatography methods by a commercial lipid analysis facility, Mylnefield Lipid Analysis, based in Dundee, Scotland.
Following the determination of the composition, the data will be compared to the existing data, and applied in established PBPK models to predict the distribution of drugs where data is already available for validation.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
19/NW/0211
Date of REC Opinion
2 May 2019
REC opinion
Further Information Favourable Opinion