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October 16, 2023

Transforming Drug Development for Neurological Disorders: Proceedings from a Multidisease Area Workshop

Neurological disorders represent some of the most challenging therapeutic areas for successful drug approvals.

October 11, 2023

Applying propensity methods to the United States transplant registry for external real-world evidence control arms for 5-year survival in the BENEFIT study

To address the challenges of assessing the impact of a reasonably likely surrogate endpoint on long-term graft survival....

September 25, 2023

Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes

New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant.

September 25, 2023

Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes

New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant.

July 25, 2023

Longitudinal estimated glomerular filtration rate (eGFR) modeling in long-term renal function to inform clinical trial design in kidney transplantation

Kidney transplantation is the preferred treatment for individuals with end-stage kidney disease. From a modeling perspective...

July 25, 2023

Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development

July 20, 2023

Acute Rejection After Kidney Transplant—An Endpoint Not Predictive of Treatment Effect on Graft Survival

July 13, 2023

Diagnostic capacities and treatment practices on implantation mycoses: Results from the 2022 WHO global online survey

Between January and March 2022, WHO conducted a global online survey to collect data on diagnostic capacities and treatment...

Drug Repurposing for Pandemic Innovation: Establishing an Effective and Efficient Ecosystem

Effective treatments for both existing and emerging diseases may already be available on pharmacy shelves. Many approved drugs...

June 12, 2023

Fosfomycin for Non-Urinary Tract Infections: a systematic review

Although fosfomycin is currently approved for treating urinary tract infections, it is increasingly being used as salvage...

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