C3p Analysis

Our facility provides a range of services including: · pharmaceutical analysis · blood sample analysis · pharmacokinetic-pharmacodynamic study design · pharmacometric modelling of data obtained · drug stability/compatibility testing · phthalate/bisphenol A leaching studies · phthalate/bisphenol A biomonitoring Our laboratory is equipped with specialised HPLC and LC/MS/MS equipment. We are experienced in the development of de novo LC and sample extraction methods for the analysis of drugs in biological fluids. We have a considerable library of validated methods. We are highly experienced in developing/performing stability-indicating LC analyses to investigate issues of drug stability, new drug formulations and new drug combinations. We can advise on developing pragmatic sampling schemes for pharmacokinetic studies, designed to enhance the robustness of the resulting pharmacokinetic parameter estimates. This maximises the amount of kinetic information that can be gained from blood sampling regimes (and allows for the use of sparse sampling regimes). We use NONMEM version 7 (the industry gold standard) and PLT Tools software for constructing mixed-effects models. As well as providing a statistically superior method of analysis, mixed effects modelling can deal with practical problems that may occur frequently in pharmacokinetic studies, such as missed blood samples.