Daily Archives: April 7, 2016

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

Let’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 […]