Drug Quality: If you can't measure it, it doesn't count

The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards — a further sign of the agency’s commitment to using quality metrics. The proposed projects, announced Friday, will evaluate batch-to-batch and unit-to-unit variability of companies’ products, capturing data on such quality chemical and physical attributes as tablet weight, assay, content uniformity and dissolution. The data will be used to create a risk-based lifecycle approach that measures quality over every step of the manufacturing process, Peter Pitts, president and founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner, tells DID.
Source: drugwonks.com Blog - Category: Pharmaceuticals Source Type: blogs