ABSTRACT
Colloidal gold, a traditional alchemical preparation, was turned into a suspension of gold nanoparticles, and colloidal drug-delivery systems became nanodrug delivery systems. The Holy Grail of any drug delivery system, whether it is nanoscale or not, is to deliver to a patient the correct dose of an active agent to a specific disease or tissue site while simultaneously minimizing toxic side effects and optimizing therapeutic benefit. The Drug Enforcement Administration is the ultrasounds (US) agency tasked with overseeing the dangerous products and enforcing the controlled substances laws. The prohibitive costs of most biologics and some small-molecule drugs have led to increased scrutiny on the US government’s role in the development of costly novel drug products. Drug development can be conceptualized as a process leading from basic research through a series of developmental steps to a commercial product. Biologics are a distinct regulatory category of drugs that differ from conventional small-molecule drugs by their manufacturing processes.
