GB-Salisbury: Pharma in vitro metabolism

NOTE: This notice was updated on 28 August 2016 for the following reason: Description of requirements changed to the following and requirement to be GLP compliant now removed as a pre-requisite to submitting an Expression of Interest Dstl is developing a number of active pharmaceutical ingredients (API) as medical countermeasures. In vitro metabolism studies of three API are required as the project moves forwards. These include determination of metabolism kinetics, metabolite identification, metabolising enzyme identification, blood:plasma ratio determination and identification of efflux transporters. All requirements will need suitably qualified analytical chemistry methods to quantify the concentrations of the API being studied. Suitable controls and appropriate factors to enable in vitro in vivo extrapolation (IVIVE) of the outputs from the work will also be required. The information/data required is in support of clinical development programmes with the API and therefore must be completed to satisfactory quality standards which must be adequately demonstrated.In vitro metabolism of the API being developed by Dstl and how this will be used to improve the understanding of the drugs as the project moves forwards to clinical trials. API must be completed to Good Laboratory Practice (GLP). Only Suppliers that have the mandatory GLP systems in place should express interest in this requirement.