The TB Alliance needed to characterize the dose- exposure-response relationship for pretomanid, an investigational TB antibiotic. Certara provided pharmacometrics expertise to facilitate programmatic decision-making and support the regulatory submission by utilizing popPK, PK/PD, and QTc modeling and analysis to inform dose/regimen selection and justification.

Using this information, a clinical trial was conducted for patients with XDR TB and treatment-intolerant or nonresponsive multidrug-resistant (TI/NR-MDR) TB. Approximately 90% of patients receiving this newly-approved regimen recovered after six months of treatment—almost 3X the success rate of prior treatment options. This groundbreaking work also resulted in the award of a tropical disease priority review voucher and sets the stage for a new approach to creating the next-generation of antibiotics for neglected diseases like TB.

Modeling and Analysis to support early decision making case study 1

The TB Alliance was the first not-for-profit organization to both develop and register an antibiotic. In 2019, the FDA approved pretomanid, only the third new drug for TB in almost 50 years.

TB Alliance is a not-for-profit organization dedicated to the discovery, development and delivery of better, faster-acting and affordable tuberculosis drugs that are available to those who need them.

Modeling and Analysis to support early decision making case study 2


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