Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation
Therapeutic monoclonal antibodies (mAbs) have been a promising therapeutic approach for several diseases and a wide variety of mAbs are being evaluated in clinical trials. To accelerate clinical development and improve the probability of success, pharmacokinetics and pharmacodynamics (PKPD) in human...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-04-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/15/5/508 |
| _version_ | 1827667456696516608 |
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| author | Kenta Haraya Haruka Tsutsui Yasunori Komori Tatsuhiko Tachibana |
| author_facet | Kenta Haraya Haruka Tsutsui Yasunori Komori Tatsuhiko Tachibana |
| author_sort | Kenta Haraya |
| collection | DOAJ |
| description | Therapeutic monoclonal antibodies (mAbs) have been a promising therapeutic approach for several diseases and a wide variety of mAbs are being evaluated in clinical trials. To accelerate clinical development and improve the probability of success, pharmacokinetics and pharmacodynamics (PKPD) in humans must be predicted before clinical trials can begin. Traditionally, empirical-approach-based PKPD prediction has been applied for a long time. Recently, modeling and simulation (M&S) methods have also become valuable for quantitatively predicting PKPD in humans. Although several models (e.g., the compartment model, Michaelis–Menten model, target-mediated drug disposition model, and physiologically based pharmacokinetic model) have been established and used to predict the PKPD of mAbs in humans, more complex mechanistic models, such as the quantitative systemics pharmacology model, have been recently developed. This review summarizes the recent advances and future direction of M&S-based approaches to the quantitative prediction of human PKPD for mAbs. |
| first_indexed | 2024-03-10T03:10:55Z |
| format | Article |
| id | doaj.art-df203e4d65ad459ea3bf350d1e9f8b11 |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-10T03:10:55Z |
| publishDate | 2022-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-df203e4d65ad459ea3bf350d1e9f8b112023-11-23T12:33:39ZengMDPI AGPharmaceuticals1424-82472022-04-0115550810.3390/ph15050508Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and SimulationKenta Haraya0Haruka Tsutsui1Yasunori Komori2Tatsuhiko Tachibana3Discovery Biologics Department, Research Division, Chugai Pharmaceutical Co., Ltd., 1-135 Komakado, Gotemba 412-8513, JapanDiscovery Biologics Department, Research Division, Chugai Pharmaceutical Co., Ltd., 1-135 Komakado, Gotemba 412-8513, JapanPharmaceutical Science Department, Translational Research Division, Chugai Pharmaceutical Co., Ltd., 1-135 Komakado, Gotemba 412-8513, JapanPharmaceutical Science Department, Translational Research Division, Chugai Pharmaceutical Co., Ltd., 1-135 Komakado, Gotemba 412-8513, JapanTherapeutic monoclonal antibodies (mAbs) have been a promising therapeutic approach for several diseases and a wide variety of mAbs are being evaluated in clinical trials. To accelerate clinical development and improve the probability of success, pharmacokinetics and pharmacodynamics (PKPD) in humans must be predicted before clinical trials can begin. Traditionally, empirical-approach-based PKPD prediction has been applied for a long time. Recently, modeling and simulation (M&S) methods have also become valuable for quantitatively predicting PKPD in humans. Although several models (e.g., the compartment model, Michaelis–Menten model, target-mediated drug disposition model, and physiologically based pharmacokinetic model) have been established and used to predict the PKPD of mAbs in humans, more complex mechanistic models, such as the quantitative systemics pharmacology model, have been recently developed. This review summarizes the recent advances and future direction of M&S-based approaches to the quantitative prediction of human PKPD for mAbs.https://www.mdpi.com/1424-8247/15/5/508therapeutic monoclonal antibodiespharmacokineticspharmacodynamicsmodeling and simulationhuman predictionTMDD |
| spellingShingle | Kenta Haraya Haruka Tsutsui Yasunori Komori Tatsuhiko Tachibana Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation Pharmaceuticals therapeutic monoclonal antibodies pharmacokinetics pharmacodynamics modeling and simulation human prediction TMDD |
| title | Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation |
| title_full | Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation |
| title_fullStr | Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation |
| title_full_unstemmed | Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation |
| title_short | Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation |
| title_sort | recent advances in translational pharmacokinetics and pharmacodynamics prediction of therapeutic antibodies using modeling and simulation |
| topic | therapeutic monoclonal antibodies pharmacokinetics pharmacodynamics modeling and simulation human prediction TMDD |
| url | https://www.mdpi.com/1424-8247/15/5/508 |
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