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Module 4_Animal PK Nonclinical study reports - Coggle Diagram
Module 4_Animal PK
Nonclinical study reports
4.1 Table of Contents of Module 4
4.2 Study Reports
4.2.1 Pharmacology
4.2.2
Pharmacokinetics
4.2.2.1 Analytical Methods and Validation Reports
4.2.2.2 Absorption
Single Dose PK
Cmax ,Tmax, AUC, t1/2, Vd, CL
Multiple Dose PK
Accumulation ratio (R)
Single/Mutiple Dose Escalation (劑量遞增）
Dose proprtionality
Bioavailability (生體可用率）
Relative bioavailability
Absolute bioavailability
4.2.2.3 Distribution
PK parameters-
Volume Distribution (Vd)
WBA
Brain drug accumulation
Placental transfer
Milk secretion
Plasma protein binding (%) at various species
Red blood cell distribution
4.2.2.4 Mrtabolism
Clearance (CL)
Liver microsomal stability-species comparison
Metabolic pathway identification
Metabolitu(s) identification
Inhibitor/inducer for human CYP isozymes
4.2.2.5 Excretion
Haif life
Renal clearance
Mass balance
Renal or biliary excretion
4.2.2.6 Pharmacokinetic Drug Interactions (nonclinical)
4.2.2.7 Other Pharmacokinetic Studies