Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations

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Items 101–200 of 232

1. Feasibility of Using Population Pharmacokinetics‐Based Virtual Control Groups in Organ Impairment Studies
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2. The use of extrapolation based on modeling and simulation to support high‐dose regimens of ceftaroline fosamil in pediatric patients with complicated skin and soft‐tissue infections
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3. Analysis of the pharmacokinetics and efficacy of RBD1016 – A GalNAc-siRNA targeting Hepatitis B Virus X gene using semi-mechanistic PK/PD model
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4. Model-informed drug development in pediatric, pregnancy and geriatric drug development: States of the art and future
   Yue‐E Wu, Yuanyuan Zheng, Qiu‐Yue Li, Bu‐Fan Yao, Jing Cao, Huixin Liu, Guo‐Xiang Hao, John van den Anker, Yi Zheng, Wei Zhao · 2024 · Advanced Drug Delivery Reviews
5. A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1: First time in man to phase II
   Jane Knöchel, Catarina A.M. Nilsson, Björn Carlsson, Linda C Wernevik, Alexis Hofherr, Peter Gennemark, Rasmus Jansson‐Löfmark, Rikard Isaksson, Tina Rydén‐Bergsten, Bengt Hamrén et al. · 2022 · CPT Pharmacometrics & Systems Pharmacology
6. PBPK-based dose finding for sildenafil in pregnant women for antenatal treatment of congenital diaphragmatic hernia
   Julia Macente, Nina Nauwelaerts, Francesca Maria Russo, Jan A. Deprest, Karel Allegaert, Bart Lammens, Rodolfo Hernandes Bonan, Jessica Turner, Sailesh Kumar, Andréa Diniz et al. · 2023 · Frontiers in Pharmacology
7. In silico trial for the assessment of givinostat dose adjustment rules based on the management of key hematological parameters in polycythemia vera patients
   Elena Maria Tosca, Alessandro De Carlo, Roberta Bartolucci, Francesco Fiorentini, Silvia Di Tollo, Maurizio Caserini, Maurizio Rocchetti, Paolo U. Bettica, Paolo Magni · 2024 · CPT Pharmacometrics & Systems Pharmacology
8. In Silico Modeling of Fabry Disease Pathophysiology for the Identification of Early Cellular Damage Biomarker Candidates
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9. Pharmacokinetic/Pharmacodynamic Modeling of the Anti-Cancer Effect of Dexamethasone in Pancreatic Cancer Xenografts and Anticipation of Human Efficacious Doses
   Ye Yao, Qingyu Yao, Yu Fu, Xiuyun Tian, Qiming An, Liang Yang, Hong Su, Wei Lu, Chunyi Hao, Tianyan Zhou · 2019 · Journal of Pharmaceutical Sciences
10. Finding new edges: systems approaches to MTOR signaling
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11. Modeling the disruption of respiratory disease clinical trials by non-pharmaceutical COVID-19 interventions
    Simon Arsène, Claire Couty, Igor Faddeenkov, Natacha Go, Solène Granjeon-Noriot, Daniel Šmít, Riad Kahoul, Ben M. W. Illigens, Jean‐Pierre Boissel, Aude Chevalier et al. · 2022 · Nature Communications
12. Longitudinal Meta‐Analysis of Historical Parkinson's Disease Trials to Inform Future Trial Design
    Usman Arshad, Fatima Rahman, Nathan Hanan, Chao Chen · 2023 · Movement Disorders
13. Model-Informed Approach Supporting Approval of Nexviazyme (Avalglucosidase Alfa-ngpt) in Pediatric Patients with Late-Onset Pompe Disease
    Ruo‐Jing Li, Lian Ma, Katarzyna Drozda, Jie Wang, Ann R. Punnoose, Linda Jo Bone Jeng, Janet W. Maynard, Hao Zhu, Michael A. Pacanowski · 2023 · The AAPS Journal
14. Sex as a Biological Variable in Early-Phase Oncology Clinical Trials: Enhancing the Path to Personalised Medicine
    Lydia Sutherland, Louise Carter · 2024 · Heliyon
15. Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region
    Mohammed S. Alasmari, Salwa Albusaysi, Marwa Elsaeed Elhefnawy, Ali Mohamed Ali, Khalid Altigani, Mohammed Almoslem, Mohammed Alharbi, Jahad Alghamdi, Abdullah Alsultan · 2024 · Saudi Pharmaceutical Journal
16. Straight to Phase III : Model‐Informed Approach Speeds Depemokimab Clinical Development in Interleukin‐5‐Driven Diseases
    Chiara Zecchin, Stein J. Schalkwijk, Isabelle J. Pouliquen, Aliénor Berges, Nicholas Bird, Richard Follows, Daren J. Austin · 2026 · Clinical Pharmacology & Therapeutics
17. Characterizing the exposure–response relationship of idecabtagene vicleucel in patients with relapsed/refractory multiple myeloma
    Jamie N. Connarn, Han Witjes, Mariëlle van Zutphen‐van Geffen, Rik de Greef, Timothy Campbell, Kristen M. Hege, Simon Yuji Zhou, Manisha Lamba · 2023 · CPT Pharmacometrics & Systems Pharmacology
18. Industry Perspective on Using MIDD for Pediatric Studies Requiring Integration of Ontogeny
    Solange Corriol‐Rohou, S. Y. Amy Cheung · 2019 · The Journal of Clinical Pharmacology
19. Evaluation and Mitigation of Time‐Dependent Confounding Effects in Conventional Exposure‐Response Analyses for Oncology Drugs
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20. Artificial intelligence assessment of the potential of tocilizumab along with corticosteroids therapy for the management of COVID-19 evoked acute respiratory distress syndrome
    Cristina Segú-Vergés, Laura Artigas, Mireia Coma, Richard Peck · 2023 · PLoS ONE
21. Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary
    Eleftheria Tsakalozou, Mohamed‐Eslam F. Mohamed, Sebastian Polak, Tycho Heimbach · 2023 · The AAPS Journal
22. Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
    Lora Hamuro, Zheyi Hu, Julie Passarell, Heather Barcomb, Joshua Zhang, Shay Goldstein, Akintunde Bello, Amit Roy, Li Zhu · 2022 · Clinical Cancer Research
23. Population pharmacokinetic/pharmacodynamic joint modeling of ixazomib efficacy and safety using data from the pivotal phase III TOURMALINE‐MM1 study in multiple myeloma patients
    Jaydeep K. Srimani, Paul M. Diderichsen, Michael J. Hanley, Karthik Venkatakrishnan, Richard Labotka, Neeraj Gupta · 2022 · CPT Pharmacometrics & Systems Pharmacology
24. How to select the initial dose for a pediatric study?
    Jingjing Ye, Youwei Bi, Naitee Ting · 2022 · Journal of Biopharmaceutical Statistics
25. Optimizing the Dosing Regimen of Cetuximab and Ramucirumab Using the Model‐Informed Drug Development Paradigm
    Lan Ni, Azhar Zaman Khan, Amanda J. Long, Ling Gao, Nikki Toms, Elena González-Gugel, Susan Holsmer‐Brand, Yong Qiang Lin, Paolo Abada, Sandra Dickin et al. · 2023 · Clinical Pharmacology & Therapeutics
26. More Than a Gut Feeling─A Combination of Physiologically Driven Dissolution and Pharmacokinetic Modeling as a Tool for Understanding Human Gastric Motility
    Michał Romański, Marcela Staniszewska, Justyna Dobosz, Daria Myslitska, Jadwiga Paszkowska, Bartosz Kołodziej, Svitlana Romаnova, Grzegorz Banach, Grzegorz Garbacz, Inese Sarceviča et al. · 2024 · Molecular Pharmaceutics
27. Recommendations for a standardized publication protocol for a QSP model
    Jared C. Weddell, Abhishek Gulati, Akihiro Yamada · 2024 · Journal of Pharmacokinetics and Pharmacodynamics
28. Longitudinal model–based meta-analysis for survival probabilities in patients with castration-resistant prostate cancer
    Wenjun Chen, Liang Li, Shuangmin Ji, Xuyang Song, Wei Lu, Tianyan Zhou · 2020 · European Journal of Clinical Pharmacology
29. Concordance of Exposure Changes Because of Renal Impairment Between Results of Dedicated Renal Impairment Studies and Population Pharmacokinetic Predictions
    Mariam Ahuoiza AHMED, Shamir N. Kalaria, Islam Rasem Younis · 2021 · The Journal of Clinical Pharmacology
30. Can quantitative pharmacology improve productivity in pharmaceutical research and development?
    Mayankbhai Patel, Tjerk Bueters · 2020 · Expert Opinion on Drug Discovery
31. Integration of Clinical Pharmacokinetic Database With Compartmental Modeling and Regulatory Data Analysis
    Oluwaseun Emmanuel Agboola, Samuel S. Agboola, Anuoluwapo Bukola Shaleye, Aniefon Samuel Umoekam, Zainab Adenike Ayinla, Temitope Yinka Olasehinde · 2026 · Current Therapeutic Research
32. Flat dose regimen of toripalimab based on model-informed drug development approach
    Lili Li, Jianye Qu, Ming Song, Qun Zhao, Yonghua Yang, Xi Tan, Yanyan Hu, Jing Li, Yunfei Lin, Hui Feng et al. · 2023 · Frontiers in Pharmacology
33. Pharmacokinetic and Pharmacodynamic Modeling (PK/PD) in Pharmaceutical Research: Current Research and Advances
    Richa Sood, A. Anita · 2024 · BENTHAM SCIENCE PUBLISHERS eBooks
34. Role of Artificial Intelligence in Clinical and Hospital Pharmacy
    Sathvik Belagodu Sridhar, Mohammed Salim Karattuthodi, Sainul Abideen Parakkal · 2024 · Nutritional neurosciences
35. Application of Quantitative Systems Pharmacology Approaches to Support Pediatric Labeling in Rare Diseases
    Susana Zaph, Randolph J. Leiser, Mengdi Tao, Chanchala D. Kaddi, Christine R. Xu · 2024 · Handbook of experimental pharmacology
36. A Modern Curriculum for Training Scientists in Model‐Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists
    Jeffrey S. Barrett, Klaus Romero, Craig R. Rayner, Marc R. Gastonguay, Goonaseelan Colin Pillai, Stacey J. Tannenbaum, Steven E. Kern, Mark Selich, Dave Francisco · 2024 · Clinical Pharmacology & Therapeutics
37. Long-Acting Formulations for the Prevention and Treatment of Human Immunodeficiency Virus (HIV)-1 Infection: Strategic Leveraging and Integration of Multidisciplinary Knowledge to Advance Public Health
    Vikram Arya, Aimee C. Hodowanec, Stephanie B. Troy, Kimberly A. Struble · 2022 · Clinical Infectious Diseases
38. Requirements, expectations, challenges and opportunities associated with training the next generation of pharmacometricians
    Stephan Schmidt, Valvanera Vozmediano, Rodrigo Cristofoletti, Sarah Kim, Zhoumeng Lin, Natália Valadares de Moraes, Francine Johansson Azeredo, Brian Cicali, Hans Leuenberger, Joshua David Brown et al. · 2023 · CPT Pharmacometrics & Systems Pharmacology
39. Navigating Recent Changes in Dosing Information: Dynamics of FDA‐Approved Monoclonal Antibodies in Post‐Marketing Realities
    Nai Lee, Su‐jin Rhee, Seong Min Koo, So Won Kim, Gyo Eun Lee, Yoon A Yie, Yun Kim · 2025 · Clinical and Translational Science
40. Translational PK/PD and model‐informed development of JNJ‐67842125, a Fab reversal agent for JNJ‐64179375, a long‐acting thrombin inhibitor
    Vivaswath S. Ayyar, Pharavee Jaiprasart, Brian J. Geist, Zheng Huang Devine, Martin Case, Anasuya Hazra, Chyi‐Hung Hsu, Madhu S. Chintala, Weirong Wang · 2021 · British Journal of Pharmacology
41. Considerations for Regulatory Reusability of Dynamic Tools in the New Drug Development
    Jiang Liu, Yuching Yang, Jogarao V. S. Gobburu, Cynthia J. Musante, Martin Klein, Liang Yu Zhao, Rajanikanth Madabushi, Hao Zhu · 2025 · Pharmaceutical Research
42. Impact of Clinical Pharmacology on the Modernization of Drug Development and Regulation
    Liang Yu Zhao, Carl C. Peck · 2023 · AAPS introductions in the pharmaceutical sciences
43. Conditional Non-parametric Bootstrap for Non-linear Mixed Effect Models
    Emmanuelle Comets, Christelle Rodrigues, Vincent Jullien, Moreno Ursino · 2021 · Pharmaceutical Research
44. Revolutionizing Drug Discovery
    Anu Sayal, Janhvi Jha, N Chaithra, Atharv Rajesh Gangodkar, S. Shaziya Banu · 2024 · Wiley eBooks
45. Population Pharmacokinetics and Exposure‐Response Relationship of Hemoporfin in Pediatric Patients With Port‐Wine Stain
    Rong Chen, Bin Zhang, Jining Tao, Qingyu Yao, Tianyan Zhou, Lin Ma, Zigang Xu · 2025 · CPT Pharmacometrics & Systems Pharmacology
46. Broader Implications of Modeling and Simulation (M&S) Tools in Pharmacotherapeutic Decisions: A Cautionary Optimism
    Ayyappa Chaturvedula, Brittany N. Palasik, Hae Jin Cho, Navin Goyal · 2020 · Frontiers in Pharmacology
47. Beta-Lactam Probability of Target Attainment Success: Cefepime as a Case Study
    Daniel J. Selig, Adrian T. Kress, Robert J. Nadeau, Jesse P. DeLuca · 2023 · Antibiotics
48. Quantitative systems pharmacology model of erythropoiesis to simulate therapies targeting anemia due to chronic kidney disease
    Mrittika Roy, Shaifali Saroha, Uddipan Sarma, Harini Sarathy, Rukmini Kumar · 2023 · Frontiers in Pharmacology
49. FDA and EMA Oversight of Disruptive Science on Application of Finite Absorption Time (F.A.T.) Concept in Oral Drug Absorption: Time for Scientific and Regulatory Changes
    Elias Toulitsis, Athanasios A. Tsekouras, Panos E. Macheras · 2024 · Pharmaceutics
50. Why Collecting Pharmacokinetic Information After Intravenous Drug Administration Is Important
    Peter H. Hinderling, Thomas Papoian · 2020 · Clinical Pharmacology in Drug Development
51. Application of the Nested Enzyme‐Within‐Enterocyte (NEWE) Turnover Model for Predicting the Time Course of Pharmacodynamic Effects
    Hiroyuki Takita, Adam S. Darwich, Amais Ahmad, Amin Rostami‐Hodjegan · 2020 · CPT Pharmacometrics & Systems Pharmacology
52. In Vitro–In Silico Modeling of Caffeine and Diclofenac Permeation in Static and Fluidic Systems with a 16HBE Lung Cell Barrier
    Lukas Kovar, Lena Wien, Dominik Selzer, Yvonne Kohl, Robert Bals, Thorsten Lehr · 2022 · Pharmaceuticals
53. A Model‐Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk
    ChennaKeshava Reddy Sannala, Carol M. MacLean, Finn Larsen, Steve van Os, Pravin R. Jadhav, Neal D. Shore, Alicia Katherine Morgans, Tochukwu M. Okwuosa, Jogarao V. S. Gobburu · 2024 · Clinical Pharmacology in Drug Development
54. Driving Efficiency: Leveraging Model‐Informed Approaches in 505(b)(2) Regulatory Actions
    Vishnu Dutt Sharma, Venkatesh Atul Bhattaram, Kevin M. Krudys, Zhihua Li, Anshu Marathe, Nitin Mehrotra, Xiaofeng Wang, Jiang Liu, Ethan M. Stier, Jeffry A. Florian et al. · 2024 · The Journal of Clinical Pharmacology
55. Emerging clinical pharmacology topics in drug development and precision medicine
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56. Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development
    Mohamed‐Eslam F. Mohamed, Insa Winzenborg, Ahmed A. Othman, Patrick J. Marroum · 2022 · The AAPS Journal
57. Introductory Chapter: The Modern-Day Drug Discovery
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58. UV-Vis Spectrophotometric Method Development and Validation of Mirabegron Via Green Approach
    Chirag H. Dhamal, Kanji D. Kachhot, Foram H. Vaghela, H. S. Joshi · 2024 · Journal of Applied Spectroscopy
59. The Role of Cross-Institutional and Interdisciplinary Collaboration in Defining and Executing a Quantitative Systems Pharmacology Strategy
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60. Integrating Quantitative Methods & Modeling and Analytical Techniques in Reverse Engineering; A Cutting-Edge Strategy in Complex Generic Development
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61. Model‐Informed Paradigm in Drug Development—An End‐To‐End Case Study From Upadacitinib Development
    Sumit Bhatnagar, Sven Stodtmann, Yuli Qian, Patrick J. Marroum, Wei Liu, Mohamed‐Eslam F. Mohamed · 2025 · Clinical and Translational Science
62. Model‐Informed Drug Development for Ligelizumab in Patients With Chronic Spontaneous Urticaria
    Andrzej Bienczak, Aurélie Gautier, Eva Hua, Yan Ji, Emil Scosyrev, Serge J. Smeets, Thomas M. Severin, Anton Drollmann, Manmath Patekar, Marina Savelieva · 2025 · CPT Pharmacometrics & Systems Pharmacology
63. Simulation-based content uniformity engineering for drug development and manufacturing
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64. Evaluation of potential drug-drug interactions in the neonatal intensive care unit with two different decision support software: a retrospective study
    Yunus Emre Ayhan, Ercan Tutak, Burak ÖZDEMİR · 2025 · BMC Pediatrics
65. Model‐Informed Drug Development for Daprodustat Supports the Design of Individualized Dosing Regimens in Chronic Kidney Disease Patients With Anemia
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66. PKGPT: Expert-Orchestrated Recursive LLM Agent for Automated NONMEM PopPK Modeling with Human Benchmarking
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67. Lipid-based nanocarriers for anticancer drug delivery: Mechanistic advances, translational challenges, and implications for generic development
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68. Advancing Pediatric Dose Scaling: Strategies, Modeling Approaches, and Clinical Applications
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69. Trends in clinical pharmacology as represented by international and specialized journals
    А. С. Колбин, К. S. Radaeva, A. Sh. Motrinchuk, Свечкарева Изабелла Размиковна · 2024 · Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice
70. Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan
    JPMA MIDD Task force, Tomohiro Sasaki, Takayuki Katsube, Seiichi Hayato, Shingo Yamaguchi, Jun Tanaka, Hiroki‎ Yoshimatsu, Yushi Nakanishi, Atsushi Kitamura, Hirotaka Watase et al. · 2025 · Journal of Pharmacokinetics and Pharmacodynamics
71. Artificial Intelligence-Based Medical Devices Revolution in Cancer Screening: Impact into Clinical Practice
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72. Pharmacometrics: The science applied from bench to bedside
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73. Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data
    Gerardus J. Hassing, Michiel Joost van Esdonk, Gerard J. P. van Westen, Adam F. Cohen, Jacobus Burggraaf, Pim Gal · 2022 · British Journal of Clinical Pharmacology
74. Global Trends in Integrating Machine Learning (ML) with Model-Informed Drug Development (MIDD): A Bibliometric and Systematic Review (2015–2025)
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75. Is It Time to Use Modeling of Cellular Transporter Homeostasis to Inform Drug-Drug Interaction Studies: Theoretical Considerations
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76. Current Status in PBPK Modeling
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77. Boundary Objects for Translating Pharmaceutical Innovations across Scientists, Engineers, Clinicians, and Regulators
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78. From Patient to Molecule: In Pursuit of Universal Treatments for TB
    Penny M. Heaton, Jeffrey S. Barrett · 2019 · Clinical and Translational Science
79. Design of clinical development programs
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80. Drug Development for New Psychiatric Drug Therapies
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81. Modelling and Simulations
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82. Special issue on applications of modeling and simulation in pharmaceutical drug development
    Venkatesh Pilla Reddy · 2021 · Biopharmaceutics & Drug Disposition
83. Translation of Pharmacodynamic Biomarkers of Antibiotic Efficacy in Specific Populations to Optimize Doses
    Manjunath P. Pai, Ryan L. Crass · 2021 · Antibiotics
84. Pharmacometrics to facilitate decision-making in pain research and perioperative management
    Nicolás Marco‐Ariño · 2022
85. Ontogeny of drug metabolism and transport: new data derived by innovative approaches
    Bianca D. van Groen, Karel Allegaert, Dick Tibboel, Saskia N. de Wildt · 2020
86. Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
    Lora Hamuro, Zheyi Hu, Julie A. Passarell, Heather Barcomb, Joshua H. Zhang, Shay Goldstein, Akintunde Bello, Amit Kumar Roy, Zhu Li · 2023
87. Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
    Lora Hamuro, Zheyi Hu, Julie A. Passarell, Heather Barcomb, Joshua H. Zhang, Shay Goldstein, Akintunde Bello, Amit Kumar Roy, Zhu Li · 2023
88. Where to from here: Advancing patient and public involvement in health technology assessment (HTA) following the COVID-19 pandemic
    2023 · Frontiers research topics
89. Simulation of optimal dose regimens of photoactivated curcumin for antimicrobial resistance pneumonia in COVID-19 patients: A modeling approach
    Teerachat Saeheng, Kesara Na‐Bangchang · 2023 · Infectious Disease Modelling
90. Consensus for international FDAs on definitions of “MAL-PD” and “Synergism”
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91. Concluding remarks
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92. MAL-PD advocacy: Public hearing, public comments and scientific recommendations
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93. Digital R&D approach to international FDA drug evaluation, clinical pharmacology, and clinical trial guidance
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94. Editorial: Pharmacometrics and systems pharmacology: Principles and applications
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95. Application of mathematical models in predicting drug dosage and its efficacy
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96. Introduction
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97. Novel biopharmaceuticals: Pharmacokinetics, pharmacodynamics, and bioanalytics
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98. Optimization of Drug Dosing Regimen
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99. How does mathematical modeling improve our understanding and design of biological immunomodulators?
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100. Pharmacodynamics‐informed Drug Discovery
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