Daryl Drummond, Merrimack Pharmaceuticals, based on his experience developing nanomaterials for industry, more specifically, novel liposome products. The section identifiers noted in parentheses below refer to the corresponding section in the guidance where this topic is discussed. Dissolution/In Vitro ...
For example, liposome simulates the cell membrane for drug delivery. Human albumin is used in nanoparticle formulations (e.g., Abraxane®). Virus-like particles or cells are also important carriers for gene therapy. The first gene therapy named Kymriah® was approved by the FDA in 2017, ...
This figure depicts the types of nanoparticles that were used in FDA-approved medicine (since 2016). The most common were polymeric drugs (29%). The second most common were liposomal drugs (22%). However, lipid-based formulations appeared to be very close to liposomal drugs among FDA-...