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PF-07302048 Biotransformation PF-07302048_05Aug20_ 043725 PFIZER CONFIDENTIA L Page 1of 34INVESTIGAT ION OF THE BIOTRANSF ORMATION OF ALC- 0159 AND ALC -0315 IN VITRO AND IN VIVO IN RATS This document contains confidential information belonging to Pfizer. Except as may be otherwise agreed to in writing, by acceptin g or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except where required by applicable law), nor to use it for…
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Medicilon Preclinical Research (Shanghai) LLC Test Article: ALC-0159 Study No.: 01049-20022 1 In Vitro Metabolic Stability of ALC -0159 in CD-1/ICR Mouse, Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey , and Human Hepatocytes Sponsor Acuitas Therapeutics Inc. 6190 Agronomy Road, Suite 402 Vancouver BC V6T 1Z3 Canada Testing Facility Medicilon Preclinical Research (Shanghai) LLC 585 Chuanda Rd, Pudong …
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Medicilon Preclinical Research (Shanghai) LLC Test Article: ALC-0159 Study No.: 01049-20021 1 In Vitro Metabolic Stability of ALC -0159 in CD -1/ICR Mouse, Sprague Dawley Rat, Cynomolgus Monkey, and Human Liver S9 Fractions Sponsor Acuitas Therapeutics Inc. 6190 Agronomy Road, Suite 402 Vancouver BC V6T 1Z3 Canada Testing Facility Medicilon Preclinical Research (Shanghai) LLC 585 Chuanda Rd, Pudong Shanghai 201299 China Study Monitor Acuitas…
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Medicilon Preclinical Research (Shanghai) LLC Test Article: ALC-0159 Study No.: 01049-20020 In Vitro Metabolic Stability of ALC -0159 in CD-1/ICR Mouse, Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey , and Human Liver Microsomes Sponsor Acuitas Therapeutics Inc. 6190 Agronomy Road, Suite 402 Vancouver BC V6T 1Z3 Canada Testing Fa cility Medicilon Preclinical Research (Shanghai) LLC 585 Chuanda Rd, Pudong …
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Medicilon Preclinical Research (Shanghai) LLC Test Article: ALC-0315 Study No.: 01049-20010 1 In Vitro Metabolic Stability of ALC -0315 in CD-1/ICR Mouse, Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey , and Human Hepatocytes Sponsor Acuitas Therapeutics Inc. 6190 Agronomy Road, Suite 402 Vancouver BC V6T 1Z3 Canada Testing Facility Medicilon Preclinical Research (Shanghai) LLC 585 Chuanda Rd, Pudong …
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Medicilon Preclinical Research (Shanghai) LLC Test Article: ALC-0315 Study No.: 01049-20009 1 In Vitro Metabolic Stability of ALC -0315 in CD -1/ICR Mouse, Sprague Dawley Rat, Cynomolgus Monkey, and Human Liver S9 Fractions Sponsor Acuitas Therapeutics Inc. 6190 Agronomy Road, Suite 402 Vancouver BC V6T 1Z3 Canada Testing Facility Medicilon Preclinical Research (Shanghai) LLC 585 Chuanda Rd, Pudong Shanghai 201299 China Study Monitor Acuitas Therapeutics …
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0HGLFLORQ 3UHFOLQLFDO 5HVHDUFK 6KDQJKDL //& 7HVW $UWLFOH $/& 6WXG\1R In Vitro Metabolic Stability of ALC-0315 in CD- 1/ICR Mouse, Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey, and Human Liver Microsomes Sponsor $FXLWDV7KHUDSHXWLFV ,QF $JURQRP\5RDG6XLWH 9DQFRXYHU%&97= &DQDGD Testing Facility 0HGLFLORQ3UHFOLQLFDO5HVHDUFK 6KDQJKDL //& &KXDQGD 5G 3XGRQJ 6KDQJKDL &KLQD Study Monitor $FXLWDV7KHUDSHXWLFV ,QF Study Director…
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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID- 19 Vaccine , mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
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Page 1 of 261 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1146 Site Name: (1146) Amici Clinical Research Subject No: 11461302 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:56 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
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Page 1 of 125 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1146 Site Name: (1146) Amici Clinical Research Subject No: 11461264 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:56 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
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Page 1 of 281 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1146 Site Name: (1146) Amici Clinical Research Subject No: 11461235 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:56 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
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VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY TITLE: Single -plex Luminex Assay for Qu antitation of IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human SerumDoc Number: VR-TM-10293 Version: 1.0 Doc. Alias: NA PFIZER CO NFIDENTIAL Page 1 TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 LIST OF FIGURES ................................ ................................…
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VACCINE RESEARCH SOP PEARL R IVER , NY TITLE: Data Review Procedures for Direct Luminex Immunoassays in VRD LabWare LIMSDoc. Number: VR-SOP-LC- 11120 Version: 4.0 Doc. Alia s: NA PFIZER CONFIDENTIAL Page 1 TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 1.HISTORICAL REVI SIONSUMMARY ................................ ................................ .............. 3 2.PURPOSE…
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VACCINE RESEARCH PEARL RIVER TITLE: Training Event Form Doc. Number: VR-SOP-QU-10321 -FM01 Vers ion: 8.0 Doc. Alias: SPI -1061A PFIZER CONFIDENT IAL Page 1 1. TRAINING EVENT Table 1. Training Event -Form Course Number VR-MVP -10074 Version # NA 1.0 Eff. Date NA (DD-MMM -YYYY) 16-NOV -2020 Course Title (Can be abbreviated) Validation Protocol for the SARS -CoV -2 mNeo nGreen Virus Microneutralization Assay Training Method Interactiv e…
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PF-07302048 : LOD Data Listing for VR-MVR-10083 VR-MVR-10083-ATT03, Ver. 1.0 PFIZER CONFIDENTIAL Page 1Title:LOD Data Listing for VR-MVR-10083 Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e1962be95b\Approved\Approved On: 09-Feb-2021 14:01 (GMT) FDA-CBER-2021-5683-0779521 PF-07302048 : LOD Data Listing for VR-MVR-10083 VR-MVR-10083-ATT03, Ver. 1.0 PFIZER…
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PF-07302048 : Precision Data Listing for VR -MVR-10083 VR-MVR-10083-ATT02, Ver. 1.0 PFIZER CONFIDENTIAL Page 1Title:Precision D ata Listing for VR-MVR-10083 Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e1962be280\Approved\Approved On: 09-Feb-2021 14:00 (GMT) FDA-CBER-2021-5683-0779504 PF-07302048 : Precision Data Listing for VR -MVR-10083 VR-MVR-10083-ATT02,…
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PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083 VR-MVR-10083-ATT01, Ver. 1.0 PFIZER CONFIDEN TIAL Page 1Title:Dilutional Linearity Data Listing for VR -MVR-10083 Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT) FDA-CBER-2021-5683-0779485 PF-07302048 : Dilutional Linearity Data Listing for…
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PF-07302048: Method Validation ofthe SARS -CoV-2 mNeonGreen Virus Microneutralization Assay VR-MVR-10083, Ver. 1.0 PFIZER CONFIDENTIAL Page 1Title:Method Validation of the SARS-CoV-2 mNeonGreen Virus Microneutralization Assay Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e196376ca2\Approved\Approved On: 09-Feb-2021 02:38 (GMT) FDA-CBER-2021-5683-0779463…
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PF-07302048 : Supportive Data for VR -MVR -10081 VR-MVR -10081-ATT01, Ver. 1.0 PFIZER CONFIDENTIAL Page 1Title: Supportive Data for VR -MVR -10081 Study Number: C4591001 Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e19487cfa1\Approved\Approved On: 31-Jul-2020 00:31 (GMT) FDA-CBER-2021-5683-0779449 PF-07302048 : Supportive Data for VR -MVR -10081 VR-MVR -10081-ATT01, Ver. 1.0…
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PF-07302048 : Method Validation Report for the Elecsys Anti -SARS -CoV- 2 Assay VR-MVR-10081 , Ver. 2.0 PFIZER CONF IDENTIAL Page 1 Title: Method Validation Report for the Elecsy s Anti- SARS -CoV -2 Assay Study Number: N/A Parent Compound Number(s): PF-07302048 Alterna tive Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl R iver, NY 090177e194c5df35\Approved\Approved On: 02-Sep-2020 18:27 (GMT) FDA-CBER-2021-5683-0779431 PF-07302048 : Method…