Don't Just Launch Your Molecule. Protect It

The ultimate goal is to bring a combination product to market that is both safe and effective, while also meeting regulatory requirements and fulfilling the needs of patients.

There are challenges, however, such as the complexity of regulations surrounding combination products, the potential incompatibility between drugs and devices, the possibility of analytical testing failures, the lack of sufficient human factors evidence, the presence of inadequate manufacturing environments, and the fragility of supply chains.

Explore the significance of carefully choosing a drug-delivery device and safeguarding the molecule in order to achieve success in the market. Review the potential risks and unforeseen challenges that can arise from delaying the selection of a delivery system.