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[资源] 药物暴露-反应关系的实验设计、数据分析和常规处理——FDA

Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory
Applications

TABLE OF CONTENTS

I.  INTRODUCTION............................................................. 1
II.  BACKGROUND ....................................................................... 2
III.  DRUG DEVELOPMENT AND REGULATORY APPLICATIONS.............................. 2
A.  Information to Support the Drug Discovery and Development Processes ..... 3
B.  Information to Support a Determination of Safety and Efficacy.... 3
IV. DOSE-CONCENTRATION-RESPONSE RELATIONSHIPS
AND EFFECTS OVER TIME..................... 8
A.  Dose and Concentration-Time Relationships ........................... 8
B.  Concentration-Response Relationships:  Two Approaches ............................ 9
V. DESIGNS OF EXPOSURE-RESPONSE STUDIES ................................... 9
A.  Population vs. Individual Exposure -Response ........................................... 10
B.  Exposure-Response Study Design............................. 10
C.  Measuring Systemic Exposure ...................................... 12
D.  Measuring Response.......................................................... 15
VI.  MODELING OF EXPOSURE-RESPONSE RELATIONSHIPS ........... 17
A.  General Considerations ............................................. 17
B.  Modeling Strategy .............................................. 17
VII.  SUBMISSION INFORMATION:  EXPOSURE-RESPONSE STUDY REPORT... 19
REFERENCES......................................................... 21
APPENDIX A:  RELATED GUIDANCES ................................... 22
APPENDIX B:  PEDIATRIC DECISION TREE INTEGRATION OF PK-PD.................. 25

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