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September 02, 2011
The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.
Internal and external Web-based communities are changing how pharma companies can innovate.
The author offers perspectives on ways in which pharmaceutical companies and other stakeholders in the supply chain can confront the threat of counterfeit products, cargo theft, illegal diversion, and economically motivated adulteration.
Might European officials reverse their position on acceptable production methods?
The third in a series of eight case studies from the Product Quality Research Institute focuses on facility biocontainment and inactivation.
Biocatalysis, chemocatalysis, and other chiral technologies continue to attract the investment dollars of CMOs and fine-chemical companies.
September 01, 2011
Direct dosing APIs during R&D studies can reduce the overall testing time of a drug candidate by allowing for a greater throughput of compounds through the R&D department.
The increasing cost of crucial manufacturing input factors, such as energy and raw materials, has been a severe threat to several companies.
Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.
The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.