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In Vitro Metabolic Stability of ALC-0315 in CD- 1/ICR Mouse, 
Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey, and 
Human Liver Microsomes
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Study Identification 
Experimental Start Date 
Experimental Completion Date 
Number of Pages in Report 
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TABLE OF CONTENTS 
SUMMARY ................................................................................................................................... 3  
SIGNATURES............................................................................................................................... 4  
1. OBJECTIVE ............................................................................................................................. 5
2. MATERIALS ............................................................................................................................ 5
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5. DATA ANALYSIS .................................................................................................................... 8
6. RESULTS .................................................................................................................................. 9
7. CONCLUSION ....................................................................................................................... 108. APPENDICES ......................................................................................................................... 14
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SUMMARY
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Table 2. Summary of Liver Microsomal Stability of ALC-0315 and Ketanserin 
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Figure 1. Stability of ALC-0315 in Mouse, R at, Monkey and Human Liver Mic rosomes 
CD-1/ICR Mouse Sprague Dawley Rat Wistar Han Rat
Cynomolgus Monkey Human
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Figure 2. Stability of Ketanserin in Mouse , Rat, Monkey and Hum an Liver Microsomes 
CD-1/ICR Mouse Sprague Dawley Rat Wistar Han Rat
Cynomolgus Monkey Human
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8. APPENDICES
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APPENDIX 1 
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21090177e19493c690\Approved\Approved On: 05-Aug-2020 20:12 (GMT)
FDA-CBER-2021-5683-0709239
 
 
In Vitro Metabolic Stability of ALC-0315 in CD-1/ICR Mouse, 
Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey, and 
Human Liver Microsomes 
Testing F acility  
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Study Director 
Sponsor 
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CONTENTS 
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1. INTRODUCTION 
1.1. Study Number 

1.2. Study Title 
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1.3. Sponsor Representative 
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1.4. Objective  
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1.5. Compliance
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1.6. Testing Facility 
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(b) (6)
(b) (6)
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(b) (6)
FDA-CBER-2021-5683-0709242
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1.8. Study Sched
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2. MATERIALS 
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3. EXPERIMENTAL PROCEDURES 
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4. BIOANALYSIS 
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5. DATA ANALYSIS 
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FDA-CBER-2021-5683-0709246
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0709247