Case 3 “Drug Delivery & Release”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion


vivaglobin releaseLet’s take a look at the next case. Number three is drug delivery or a different kind of drug release. The brand examples here are Vivaglobin, an IVIg product, and the octreotide implant that was a growth hormone inhibitor product in development at a major pharma company.

The key claim for both of these is that there would be no more roller coaster of drug effects, either over delivery of the drug, which would cause untoward side effects, or, along the way, a roller coaster down of loss of effect and even under-protection because the product went below the therapeutic window.

Overall, the theme for both of these would be something like smoother is better, smoother drug levels rather than the constant up and down could be better for the patient and could be realized with the drug delivery and release profiles of both of these brands.

The lesson learned was that the therapeutic window must be demonstrated in clinical results. If the drug release was too high, would you see side effects from an over-dosage of medication? If the medication was below the therapeutic window, would you see worsening of symptoms or even breakthrough clinical disease effects?

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