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®SCS Capabilities — Population PK Modeling and Analysis
Population PK analysis includes design of add-on sub-studies during proof-of-concept, Phase IIb, Phase III and Phase IV; data management; the analysis plan; population PK analysis; analytical reporting; and formal QC/QA checks.
Population PK analysis is critical to understanding the magnitude of patient variability in PK and elucidates intrinsic (patient covariates) and extrinsic causes of patient variability. Population PK analysis is performed in compliance with EMEA, FDA, ICH, and Japanese guidelines.
Increased understanding of population variability in response supports fewer failed studies and a more efficient development path.