Clinical Pharmacology
● Translational Pharmacology and ADME
● Clinical Pharmacology Study Design
○ Timing and strategy for study design
● Customize based on Drug Modality
○ Small molecule vs. large molecule
● Early vs. Late Phase Drug Development
● Clinical Pharmacology Gap Analysis and
Development Pathway Mapping in
support of Decision Making
● IND to NDA/BLA/MAA submission support
(briefing books, eCTD:2.7.1 and 2.7.2)
● iPSP and PIP for Phase 3 program
Pharmacokinetic Analysis
● Non-compartmental Analysis
● First-in-human Dose Selection
● Allometric Scaling and Dose Selection
● Dose Proportionality Assessment
● Bioequivalent and relative Bioavailability
Analysis
● Food effect and DDI Analysis
● CDISC PC/PP/IS and ADaM ADPC
/ADPP/ADIS
● PK Report and CSR Report
Modeling and Simulation
● Translational Pharmacokinetic/
Pharmacodynamic (PK/PD) Modeling
● Population PK dataset preparation
and Exploratory Data Analysis
● Population PK Modeling and Simulation
● Exposure-safety and Exposure-efficacy
(Exposure-response) Analysis
● PopPK/PD Report and Simulation Report
● Mechanistic Modeling and Sensitivity
Analysis
● PK/QTc Analysis
● DDI Modeling
● IVIVC to support Biopharmaceutical
Development
● Model Informed Drug Development and
Pediatric Dose/Extrapolation Framework