News & Analysis on Clinical Trial Services & Contract Research And Development
Stability testing is, in essence, a quality control process and is therefore a vital component of every phase of clinical development for both large and small molecules – from early phase through to and including post approval. It should be treated as an ongoing program rather than as a periodic exercise.
Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed, proteins, given their chemistry, are the “most structurally complex and functionally sophisticated...
Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent of Phase III studies failed due to safety (compared to 55 percent for efficacy), down from 21...
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