New Formulation & Vehicle Evaluation
In the context of new formulation evaluation projects assigned by sponsors, our work involves the Method development and validation for the analysis of biomolecules (such as peptides and small molecule drugs), using advanced analytical instrumentation, such as HPLC-MS/MS. We use our methods to perform release assay studies of drugs from novel particles (such as liposomes, PLGA particles, etc.) either in in-vitro appropriate medium simulating in vivo settings (e.g. different pH conditions, lysosomes, etc.) or in in-vivo suitable matrices (e.g. plasma or serum).
IWe then design Pharmacokinetic studies in appropriate animal models (e.g, mouse or rat) depending on the question that needs to be addressed. The process includes the identification of: i) the optimal route of administration (e.g., IP, IV or PO), ii) the proper protocol for sample collection (time points).Finally, upon execution of experiment and analysis we perform quantitative and statistical data analysis and generate reports for the new formulation.