PK/ADME
Seventh Wave provides expert strategic and technical guidance in the area of PK/ADME science at all stages of R&D, from due diligence evaluation of new ideas through regulatory document preparation and meetings with regulatory agencies. We help our clients plan and conduct the right studies and manage other activities to meet timelines to advance drug candidates through the development process. Seventh Wave can perform PK studies, including in-life conduct and quantitative analysis of test articles (small molecules and biotherapeutics) in biological samples, to fully assess the PK properties of experimental agents. A variety of protocols, described below, can be implemented to determine total and renal clearance, distribution volume, terminal half-life, bioavailability, and other PK parameters. Alternatively, we can receive bioanalytical data from client companies for interpretation and report preparation. Seventh Wave also has in place validated software, data handling SOPs, and internal audit capabilities to meet GLP and GCP requirements for toxicokinetic (TK) analysis in preclinical safety studies and clinical trials.