The road to market for new drugs and pharmaceutical products is long and complicated. Each stage of drug development is highly scrutinized by the FDA, enabling patient populations and providers to confidently rely on the product.
Parenteral drugs broadly defines a category of medication that is delivered via injection. New drugs typically come to market as parenteral because they are highly reliable in dosage precision and are administered by a professional. Injections also allow for rapid onset of the drug’s effectiveness. When a drug is delivered directly into the bloodstream without having to be absorbed through the stomach, as with oral medications, there are increased safety considerations and patient risks. Injection risks include potential contamination or unanticipated changes in the drug’s chemistry since the bloodstream has minimal natural barriers to protect from damaging side effects. Due to risks, developing parenteral drugs presents significant manufacturing challenges.