Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...

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

There has been much discussion recently about how artificial intelligence and machine learning (AI/ML) will revolutionize pharmaceutical research. Substantial progress has been made in the discovery ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...

It’s always a high-stakes gamble in the pharmaceutical industry to develop a new drug. The process typically takes 10 to 15 years and requires extensive testing, regulatory approval, and clinical ...

In my previous article, I discussed how AI is rapidly transforming the drug discovery process, significantly accelerating timelines and reducing costs. However, while AI's potential in this domain is ...

The development of new medication by biotech and pharmaceutical companies, from target identification to marketing approval, is a time-consuming process with timelines extending to 12 years or more.

Small molecules like gabapentin, metformin and ibuprofen are still the mainstay of the pharmaceutical trade because they are easy to make and distribute and can get around the body. But they also have ...