| | | | | | | | | | | | | | | | |
| | |
 | Issue Date FY: 2025 ( Subtotal = $248,087 ) |
| | 2025 | 2025 | SIMULATIONS PLUS INC | 800 PARK OFFICES DR STE 401 | RESEARCH TRIANGLE PARK | NC | 27709-1014 | DURHAM | USA | U01FD008388 | From Bench to Bioequivalence: In Vitro Mechanistic Understanding of ASD Drug Products in Simulated Gastrointestinal Conditions | 000 | 2 | FDA | 8/27/2025 | $249,485 |
| | 2025 | 2024 | SIMULATIONS PLUS INC | 800 PARK OFFICES DR STE 401 | RESEARCH TRIANGLE PARK | NC | 27709-1014 | DURHAM | USA | U01FD007906 | Development and validation of a workflow to conduct virtual bioequivalence studies using PBBM-PBPK models | 000 | 2 | FDA | 6/19/2025 | $0 |
| | 2025 | 2024 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 000 | 3 | FDA | 2/10/2025 | $0 |
| | 2025 | 2023 | SIMULATIONS PLUS INC | 800 PARK OFFICES DR STE 401 | RESEARCH TRIANGLE PARK | NC | 27709-1014 | DURHAM | USA | R44TR003535 | Software for predicting liver injury from biologics drug candidates using data from a human liver microphysiology system | 000 | 4 | NIH | 6/26/2025 | -$1,398 |
| | 2025 | 2022 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD007320 | Dermal Drug Product Quality and Bioequivalence Assessment through Advanced MAM and PBPK Simulation | 000 | 2 | FDA | 3/19/2025 | $0 |
|
| Issue Date FY: 2024 ( Subtotal = $905,749 ) |
| | 2024 | 2024 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 004 | 3 | FDA | 2/20/2024 | $0 |
| | 2024 | 2024 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 002 | 3 | FDA | 1/18/2024 | $100,000 |
| | 2024 | 2024 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD008388 | From Bench to Bioequivalence: In Vitro Mechanistic Understanding of ASD Drug Products in Simulated Gastrointestinal Conditions | 000 | 1 | FDA | 9/2/2024 | $249,485 |
| | 2024 | 2024 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | R43GM156103 | Improving Similarity Scoring in Drug Discovery: Solving by Solvating | 001 | 1 | NIH | 9/24/2024 | $0 |
| | 2024 | 2024 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD007906 | Development and validation of a workflow to conduct virtual bioequivalence studies using PBBM-PBPK models | 000 | 2 | FDA | 8/28/2024 | $249,392 |
| | 2024 | 2024 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | R43GM156103 | Improving Similarity Scoring in Drug Discovery: Solving by Solvating | 000 | 1 | NIH | 9/6/2024 | $306,872 |
| | 2024 | 2023 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 001 | 3 | FDA | 1/9/2024 | $0 |
| | 2024 | 2023 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 003 | 3 | FDA | 1/24/2024 | -$100,000 |
| | 2024 | 2023 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 000 | 3 | FDA | 11/20/2023 | $100,000 |
| | 2024 | 2022 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 005 | 3 | FDA | 6/7/2024 | $0 |
|
| Issue Date FY: 2023 ( Subtotal = $1,084,044 ) |
| | 2023 | 2023 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD007906 | Development and validation of a workflow to conduct virtual bioequivalence studies using PBBM-PBPK models | 000 | 1 | FDA | 9/12/2023 | $249,640 |
| | 2023 | 2023 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | R44TR003535 | Software for predicting liver injury from biologics drug candidates using data from a human liver microphysiology system | 000 | 4 | NIH | 5/5/2023 | $834,404 |
| | 2023 | 2022 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | R44TR003535 | Software for predicting liver injury from biologics drug candidates using data from a human liver microphysiology system | 001 | 3 | NIH | 8/21/2023 | $1 |
| | 2023 | 2021 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | R43TR003535 | Software for Predicting Liver Injury from Biologics Drug Candidates Using Data from a Human Liver Microphysiology System | 002 | 2 | NIH | 8/21/2023 | -$1 |
| | 2023 | 2019 | SIMULATIONS PLUS INC | 42505 10TH ST W STE 103 | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006526 | Assessment of Transdermal Drug Product Quality and Performance Attributes via Enhanced Virtual Bioequivalence Simulations | 000 | 2 | FDA | 12/5/2022 | $0 |
|
| Issue Date FY: 2022 ( Subtotal = $1,297,307 ) |
| | 2022 | 2022 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD007320 | Dermal Drug Product Quality and Bioequivalence Assessment through Advanced MAM and PBPK Simulation | 000 | 2 | FDA | 7/22/2022 | $250,000 |
| | 2022 | 2022 | SIMULATIONS PLUS, INC. | 42505, 10TH STREET WEST | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 000 | 3 | FDA | 8/19/2022 | $40,000 |
| | 2022 | 2022 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | R44TR003535 | Software for predicting liver injury from biologics drug candidates using data from a human liver microphysiology system | 000 | 3 | NIH | 2/25/2022 | $862,693 |
| | 2022 | 2021 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | R43TR003535 | Software for Predicting Liver Injury from Biologics Drug Candidates Using Data from a Human Liver Microphysiology System | 001 | 2 | NIH | 11/13/2021 | $144,614 |
|
| Issue Date FY: 2021 ( Subtotal = -$522,155 ) |
| | 2021 | 2021 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 000 | 2 | FDA | 8/3/2021 | $180,000 |
| | 2021 | 2021 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD007320 | Dermal Drug Product Quality and Bioequivalence Assessment through Advanced MAM and PBPK Simulation | 000 | 1 | FDA | 9/2/2021 | $250,000 |
| | 2021 | 2017 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD005463 | Development of PBPK simulation for long-acting injectable microspheres | 000 | 3 | FDA | 7/8/2021 | -$159,183 |
| | 2021 | 2016 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD005211 | PBPK Modeling and Simulation for Ocular Dosage Forms | 002 | 3 | FDA | 8/16/2021 | -$200,000 |
| | 2021 | 2016 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD005211 | PBPK Modeling and Simulation for Ocular Dosage Forms | 003 | 3 | FDA | 9/13/2021 | -$200,000 |
| | 2021 | 2016 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD005211 | PBPK Modeling and Simulation for Ocular Dosage Forms | 001 | 3 | FDA | 7/8/2021 | -$200,000 |
| | 2021 | 2015 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD005211 | PBPK Modeling and Simulation for Ocular Dosage Forms | 000 | 2 | FDA | 7/8/2021 | -$192,972 |
|
| Issue Date FY: 2020 ( Subtotal = $180,000 ) |
| | 2020 | 2020 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006927 | Development and Validation of a PBPK/PD Modeling Strategy for Ophthalmic Drug Products to Support Translation from Preclinical Species to Human | 000 | 1 | FDA | 5/18/2020 | $180,000 |
| | 2020 | 2019 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006526 | Assessment of Transdermal Drug Product Quality and Performance Attributes via Enhanced Virtual Bioequivalence Simulations | 000 | 2 | FDA | 8/7/2020 | $0 |
|
| Issue Date FY: 2019 ( Subtotal = $250,000 ) |
| | 2019 | 2019 | SIMULATIONS PLUS, INC. | 42505 10TH ST W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006526 | Assessment of Transdermal Drug Product Quality and Performance Attributes via Enhanced Virtual Bioequivalence Simulations | 000 | 2 | FDA | 8/14/2019 | $250,000 |
|
| Issue Date FY: 2018 ( Subtotal = $253,440 ) |
| | 2018 | 2018 | SIMULATIONS PLUS, INC. | 42505 10TH STREET W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006526 | Assessment of Transdermal Drug Product Quality and Performance Attributes via Enhanced Virtual Bioequivalence Simulations | 001 | 1 | FDA | 8/29/2018 | -$253,440 |
| | 2018 | 2018 | SIMULATIONS PLUS, INC. | 42505 10TH STREET W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006526 | Assessment of Transdermal Drug Product Quality and Performance Attributes via Enhanced Virtual Bioequivalence Simulations | 001 | 1 | FDA | 8/29/2018 | $253,440 |
| | 2018 | 2018 | SIMULATIONS PLUS, INC. | 42505 10TH STREET W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD006526 | Assessment of Transdermal Drug Product Quality and Performance Attributes via Enhanced Virtual Bioequivalence Simulations | 000 | 1 | FDA | 8/28/2018 | $253,440 |
|
| Issue Date FY: 2017 ( Subtotal = $200,000 ) |
| | 2017 | 2017 | SIMULATIONS PLUS, INC. | 42505 10TH STREET W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD005463 | Development of PBPK simulation for long-acting injectable microspheres | 000 | 3 | FDA | 8/8/2017 | $200,000 |
| | 2017 | 2016 | SIMULATIONS PLUS, INC. | 42505 10TH STREET W | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD005211 | PBPK Modeling and Simulation for Ocular Dosage Forms | 000 | 3 | FDA | 8/24/2017 | $0 |
|
| Issue Date FY: 2016 ( Subtotal = $400,000 ) (Continued on the next page) |
| | 2016 | 2016 | SIMULATIONS PLUS INC | 42505 10TH STREET WEST | LANCASTER | CA | 93534-7059 | LOS ANGELES | USA | U01FD005211 | PBPK Modeling and Simulation for Ocular Dosage Forms | 000 | 3 | FDA | 8/24/2016 | $200,000 |
|
