Exploring Best-Practice Manufacturing Strategies For Highly Potent Oral Solid Dosage Forms

As the number of highly potent oral solid dose (HPOSD) drugs in development and on the market increase, regulatory expectations continue to evolve. The successful development of these drug products is challenged by several factors relative to occupational safety and health during development and manufacture, as well as downstream, when medications reach patients at the point of care.

To achieve and sustain compliance, drug developers and their partners must develop a clear understanding of HPOSD’s unique challenges to successfully navigate the complexities of its highly-regulated manufacturing environment.

Pfizer CentreOne examines the regulatory considerations for today’s HPOSD products.