Pharmaceutical Technology-09-02-2004

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In the Spotlight-Pharmaceutical Science & Technology Innovations

FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.

Emerging high-tech solutions prepare to cater to industrial automation with promises of increased efficiencies, faster communications, and custom applications.

Pharmaceutical Science & Technology News

The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

In this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.

Early development services continue to be a sweet spot for contract R&D services. The big question is how soon the impact of early-development candidates will be felt in late development and commercialization.

Particulate generation and durability concerns are encouraging pharmaceutical manufacturers to seek alternatives to wood pallets.