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System for Efficacy and Cytotoxicity Screening of Inhibitors Targeting Intracellular Mycobacterium tuberculosis
Published on: April 5, 2017
Models and approaches for anti-TB drug testing
Yuliya Yasinskaya1, Leonard Sacks
1Office of Critical Path Programs in the Office of the Chief Scientist, US FDA, 10903 New Hampshire Avenue, Building 32, Silver Spring, MD 20993, USA. yuliya.yasinskaya@fda.hhs.gov
Expert Review of Anti-Infective Therapy
|August 4, 2011
Summary
Developing new tuberculosis (TB) drugs faces challenges due to high efficacy standards of current treatments and evolving regulatory demands. Innovative models are crucial for demonstrating the effectiveness of novel TB therapies.
Area of Science:
- Microbiology
- Pharmacology
- Clinical Trials
Background:
- Existing tuberculosis (TB) treatments are lengthy and pose adherence challenges, despite high efficacy.
- Regulatory standards for new TB drugs require rigorous characterization within combination regimens.
- Traditional biomarkers like mycobacterial cultures have limitations in predicting long-term treatment outcomes.
Purpose of the Study:
- To review nonclinical and clinical models for assessing the bactericidal and sterilizing activity of new anti-TB compounds.
- To discuss innovative approaches for evaluating drug efficacy in TB treatment development.
- To highlight the need for advanced models to support the development of new TB drugs.
Main Methods:
- Review of existing nonclinical models (in vitro, animal studies).
- Evaluation of clinical models and sensitive biomarkers.
- Discussion of novel clinical trial designs for TB drug development.
Main Results:
- Traditional methods for assessing drug efficacy in TB have limitations.
- Novel in vitro, animal models, biomarkers, and clinical trial designs offer improved characterization of drug activity.
- These innovative approaches are essential for meeting regulatory standards.
Conclusions:
- New models are essential to overcome challenges in developing effective TB drugs.
- Innovative approaches promise to expand the TB treatment armamentarium with potent drugs and shorter regimens.
- Advancements in preclinical and clinical evaluation are key to combating tuberculosis effectively.
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