Pharmacokinetics

Links to major regulatory information of pharmacokinetics.
 

Regulations and Notifications

Physiologically based Pharmacokinetic Models

• Guidelines for Analysis Reports Involving Physiologically based Pharmacokinetic Models[405.59KB]

December 21, 2020 PSEHB/PED Notification No. 1221-1

 

Exposure-Response Analysis of Drugs

• Guideline for Exposure-Response Analysis of Drugs[741.29KB]

June 8, 2020 PSEHB/PED Administrative Notice

 

Population Pharmacokinetic and Pharmacodynamic Analysis

• Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis[384KB]

June 19, 2019 PSEHB/PED Administrative Notice

 

Drug interaction

• Points to Consider for Clinical Evaluation of Drug-Drug Interactions using Endogenous Biomarker (Early consideration)[129.18KB]

February 14, 2025 Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
 

• Annex1 Guideline on drug interaction for drug development and appropriate provision of information,Annex2 Question and Answer for the “Guideline on drug interaction for drug development and appropriate provision of information”[1,095KB]

February 8, 2019 PSEHB/PED Administrative Notice

Bioanalytical Method

• Annex1 Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development,Annex2 Questions and Answers (Q&A) for the Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development[332KB]

May 30, 2014 PSEHB/PED Administrative Notice

 

• Annex1 Guideline on Bioanalytical Method Validation in Pharmaceutical Development,Annex2 Questions and Answers (Q&A) for the Guideline on Bioanalytical Method Validation in Pharmaceutical Development

September 13, 2013 PSEHB/PED Administrative Notice