Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

Discover how early CMC, process optimization, and formulation strategy drive scalable, commercially viable drugs.

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Explore how patient experience data shapes regulatory drug decisions, enhancing the patient-focused drug development initiative for better treatment outcomes. Patient experience data are critical to ...

Solubility is an essential characteristic for any oral medication, directly governing the drug’s bioavailability and efficacy. However, this requirement is running up against the growing ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

As drug costs rise and public trust falls, A.I. may transform the economics of clinical trials—and reshape the future of pharma. Unsplash+ Sixty percent of the total U.S. population takes at least one ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...