Yousif S Alakeel, Emmanouil Rampakakis, Ali AlRumaih, Rana AlRuwaisan, Maha Abushal, Abdullah M AlDalaan, Majdy M Idrees, Zaid D Alanazi, Hanouf AlKoait, Abdulrahman Muaadi, Majed Ali M AlAfra, Shaya A AlShaya, Suliman AlHomida
In an era of cost pressure, substituting generic drugs represents one of the main cost-containment strategies of healthcare systems. Despite the obvious financial benefits, in a minority of cases, substitution may require caution or even be contraindicated. In most jurisdictions, to obtain approval, the bioequivalence of generic products with the brand-name equivalent needs to be shown via bioavailability studies in healthy subjects. Rare diseases, defined as medical conditions with a low prevalence, are a group of heterogenous diseases that are typically severe, disabling, progressive, degenerative, and life-threatening or chronically debilitating, and disproportionally affect the very young and elderly...
2024: Frontiers in Pharmacology