We provide services to help clients identify key aspects in PK, PD and Metabolism to move projects forwards
Analytical and bioanalytical method development/validation
Analytical and bioanalytical analysis of samples in various in vitro, preclinical and clinical matrixes
Impurity and metabolite structure elucidation
Experimental evaluation of physical chemistry and pharmaceutical properties including drug metabolism, drug-drug interaction, protein binding, solubility, stability and formulations
Consulting Services:
Preclinical and clinical PK, PD, PK/PD and ADME study design, data analysis and report writing
Design and monitoring of IND-enabling toxicology studies and analysis of TK data
Preparation of study reports for regulatory filing
Review and preparation of clinical protocols and investigators brochures
First-in-Man dose selection, Ph II dose selection
Design and analysis of BA, BE, food effect and formulation studies
