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Quality by design with a focus on biosimilars

Pharmaceutical Technology

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.

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Jailed pharma exec fined £47m and banned from industry

pharmaphorum

The company was slammed for restricting distribution of its drug so generic drug manufacturers couldn’t conduct bioequivalence tests or access a key ingredient used in the drug’s production. Toxoplasmosis results from infection with the toxoplasma gondii parasite, one of the world’s most common parasites.

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Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

In vitro release testing to demonstrate bioequivalence. Products must also be tested for bioburden to demonstrate that they do not harbour microbial contaminants. Even the smallest details can have a big impact on the end result, especially when it comes to the sensory characteristics and the bioequivalence of a topical product.