In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer tha......more

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviat......more

A Western-Based Approach to Analyzing TCMs In recent years, many pharmaceutical companies and clinical research organiza......more

This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended ......more

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar prod......more

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviat......more

The US Food and Drug Administration s Report to the Nation in 2004 and 2005 indicated that one of the top reasons for d......more