PK/PD Analysis
PK/PD analysis is employed to quantitatively elucidate the impact of drugs on the human body, as well as the pharmacological or toxicological effects of the drugs. The team members at the GoBroad Clinical Research Center provide comprehensive support throughout the research process, starting from protocol design and real-time analysis during the study to final data analysis and reporting, and extending to regulatory communication or inspection. Utilizing Non-Compartmental Analysis (NCA) or modeling methods integrated with statistics and programming to deliver standardized analytical data, the team has amassed continuous experience and successful cases in clinical trials of chemical drugs, therapeutic proteins, and cellular immunotherapy products. This includes a range of studies such as innovative drug Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) studies, Food Effect studies, Drug-Drug Interaction studies, Thorough QT/Concentration-QT (TQT/CQT) studies, Human Radiolabeled Mass Balance/BA Studies, Bioequivalence (BE), Biosimilar assessment, as well as Population Pharmacokinetic (PopPK) studies. Drawing upon the team's rich experience in bioanalysis and laboratory audits, laboratory monitoring services are also available to ensure the reliability of PK or PD sample analysis data.