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Module 5_Human PK Clinical Study Reports - Coggle Diagram
Module 5_Human PK
Clinical Study Reports
5.1 Table of Contents of Module 5
5.2 Tabular Listing of All Clinical Studies
5.3 Clinical Study Reports
5.3.1 Reports of
Biopharmacertic
Studies
5.3.1.1 Bioavailability (ΒA) study Reports
5.3.1.2 Comparative ΒA and Bioequivalence (BE) reports
5.3.1.3 In Vitro- In Vivo Correlation Study Reports
5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using
Human Biomaterials
5.3.2.1 Plasma Protein Binding Study Reports
5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies
5.3.2.3 Reports of Studies Using Other Human Biomaterials
5.3.3 Reports of
Human Pharmacokinetic (PK)
Studies
5.3.3.1 Healthy Subject PK and Initial Tolerability study reports
5.3.3.2 Patient PK and Initial Tolerability Study Reports
5.3.3.3 Intrinsic Factor PK Study Reports
5.3.3.4 Extrinsic Factor PK Studies Reports
5.3.3.5 Population PK Study Reports
5.3.4 Reports of Human
Pharmacodynamic (PD)
Studies
5.3.4.1 Healthy Subject PD and PK/PD Study
5.3.4.2 Patient PD and PK/PD Study Reports