Anti-abuse formulations
There are formulations created to reduce the possibility of drug abuse and misuse, making it difficult to administer it in conditions other than those approved. [...]
Dr. Roberto Gabach: “If it is difficult you plan, if it is impossible you try”
Dr. Gabach, our director & manager of New Projects, analyzes the present and gives us a preview of the future of Amarin and the transdermal market. [...]
505(b)(2) and Hybrid Pathways for Transdermal Drug Delivery: Strategy, Data Requirements, and Exclusivity
For a pharmaceutical company evaluating whether to develop a transdermal drug delivery system based on a molecule already approved in another dosage form, the regulatory pathway choice is one of the most consequential strategic decisions of the project. [...]