Qualification opinion in-vitro hollow fiber system model of tuberculosis (HSF-TB)
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Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool.
The first nonclinical drug development tool (DDT) advanced by the Critical Path to TB Drug Regimens (CPTR) Initiative through a regulatory review process has been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbiological outcomes are needed to support decision making. Regulatory endorsement of these DDTs is critical for drug d...
متن کاملForecasting Accuracy of the Hollow Fiber Model of Tuberculosis for Clinical Therapeutic Outcomes.
BACKGROUND The hollow fiber system model of tuberculosis (HFS-TB), in tandem with Monte Carlo experiments, represents a drug development tool (DDT) with the potential for use to develop tuberculosis treatment regimens. However, the predictive accuracy of the HFS-TB, or any other nonclinical DDT such as an animal model, has yet to be robustly evaluated. METHODS To avoid hindsight bias, a liter...
متن کاملHollow Fiber System Model for Tuberculosis: The European Medicines Agency Experience.
The in vitro hollow fiber system model has been qualified by the European Medicines Agency as a methodology for use in support of selection and development of antituberculosis regimens. More data are expected to be generated in the future to further characterize its value.
متن کاملThe Hollow Fiber System Model in the Nonclinical Evaluation of Antituberculosis Drug Regimens.
Tuberculosis remains a serious public health challenge, with the global prevalence of active disease estimated at 8.6 million and the mortality rate at 1.3 million deaths per year [1]. In 2012, the Centers for Disease Control and Prevention reported approximately 10 000 cases in the United States, of which approximately 1% were resistant to both rifampin and isoniazid [2]. These epidemiologic d...
متن کاملAmikacin Optimal Exposure Targets in the Hollow-Fiber System Model of Tuberculosis
Aminoglycosides such as amikacin are currently used for the treatment of multidrug-resistant tuberculosis (MDR-TB). However, formal pharmacokinetic/pharmacodynamic (PK/PD) studies to identify amikacin exposures and dosing schedules that optimize Mycobacterium tuberculosis killing have not been performed. It is believed that aminoglycosides do not work well under acidic conditions, which, if tru...
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