Motor symptoms are a core feature of Parkinson’s disease (PD) and cause a significant burden on patients’ quality of life. Oral levodopa is still the most effective treatment, however, the motor benefits are countered by inherent pharmacologic limitations of the drug. Additionally, with disease...
Lisa Conte is the founder, president, and chief executive officer, and a member of the board of directors, of Jaguar. Mytesi®, the company’s FDA-approved drug product indicated for the symptomatic relief of noninfectious diarrhea in adults with HIV/AID...
these results in clinical practice is challenging, and substantial differences in trial design impede cross-trial comparisons. Recent PARP inhibitor approvals (olaparib, niraparib) in the newly diagnosed EOC setting have provided new maintenance treatment options for a broader patient population. The ...
Guidance for Industry, Bioavailability and Bioequivalence Studies Submitted in NDAs or—General Considerations; US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research. 2014. Available online: https://www.fda.gov/media/88254/download (accessed on ...
US FDA Guidance describes the model-independent mathematical approach proposed by Moore and Flanner for calculating a similarity factor (f2) of dissolution testing of immediate-release solid oral dosage forms describes that drug dissolution may be the rate-limiting step for drug absorption in the ...