Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches
The development of novel tuberculosis (TB) multi-drug regimens that are more efficacious and of shorter duration requires a robust drug development pipeline. Advances in quantitative modeling and simulation can be used to maximize the utility of patient-level data from prior and contemporary clinica...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2017-03-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971216311912 |
| _version_ | 1811263462210273280 |
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| author | Debra Hanna Klaus Romero Marco Schito |
| author_facet | Debra Hanna Klaus Romero Marco Schito |
| author_sort | Debra Hanna |
| collection | DOAJ |
| description | The development of novel tuberculosis (TB) multi-drug regimens that are more efficacious and of shorter duration requires a robust drug development pipeline. Advances in quantitative modeling and simulation can be used to maximize the utility of patient-level data from prior and contemporary clinical trials, thus optimizing study design for anti-TB regimens. This perspective article highlights the work of seven project teams developing first-in-class translational and quantitative methodologies that aim to inform drug development decision-making, dose selection, trial design, and safety assessments, in order to achieve shorter and safer therapies for patients in need. These tools offer the opportunity to evaluate multiple hypotheses and provide a means to identify, quantify, and understand relevant sources of variability, to optimize translation and clinical trial design. When incorporated into the broader regulatory sciences framework, these efforts have the potential to transform the development paradigm for TB combination development, as well as other areas of global health. |
| first_indexed | 2024-04-12T19:44:37Z |
| format | Article |
| id | doaj.art-cb74c0144f2142769bbf1252892b0361 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 1878-3511 |
| language | English |
| last_indexed | 2024-04-12T19:44:37Z |
| publishDate | 2017-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-cb74c0144f2142769bbf1252892b03612022-12-22T03:18:59ZengElsevierInternational Journal of Infectious Diseases1201-97121878-35112017-03-0156C20821110.1016/j.ijid.2016.10.008Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approachesDebra HannaKlaus RomeroMarco SchitoThe development of novel tuberculosis (TB) multi-drug regimens that are more efficacious and of shorter duration requires a robust drug development pipeline. Advances in quantitative modeling and simulation can be used to maximize the utility of patient-level data from prior and contemporary clinical trials, thus optimizing study design for anti-TB regimens. This perspective article highlights the work of seven project teams developing first-in-class translational and quantitative methodologies that aim to inform drug development decision-making, dose selection, trial design, and safety assessments, in order to achieve shorter and safer therapies for patients in need. These tools offer the opportunity to evaluate multiple hypotheses and provide a means to identify, quantify, and understand relevant sources of variability, to optimize translation and clinical trial design. When incorporated into the broader regulatory sciences framework, these efforts have the potential to transform the development paradigm for TB combination development, as well as other areas of global health.http://www.sciencedirect.com/science/article/pii/S1201971216311912Tuberculosis (TB)ModelingSimulationPharmacokinetic/pharmacodynamics (PK/PD)Drug developmentTranslational science |
| spellingShingle | Debra Hanna Klaus Romero Marco Schito Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches International Journal of Infectious Diseases Tuberculosis (TB) Modeling Simulation Pharmacokinetic/pharmacodynamics (PK/PD) Drug development Translational science |
| title | Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches |
| title_full | Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches |
| title_fullStr | Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches |
| title_full_unstemmed | Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches |
| title_short | Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches |
| title_sort | advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches |
| topic | Tuberculosis (TB) Modeling Simulation Pharmacokinetic/pharmacodynamics (PK/PD) Drug development Translational science |
| url | http://www.sciencedirect.com/science/article/pii/S1201971216311912 |
| work_keys_str_mv | AT debrahanna advancingtuberculosisdrugregimendevelopmentthroughinnovativequantitativetranslationalpharmacologymethodsandapproaches AT klausromero advancingtuberculosisdrugregimendevelopmentthroughinnovativequantitativetranslationalpharmacologymethodsandapproaches AT marcoschito advancingtuberculosisdrugregimendevelopmentthroughinnovativequantitativetranslationalpharmacologymethodsandapproaches |