Pharmaceutical Technology-02-02-2002

EVA takes into account a project's schedule and budget to determine the true cost performance.

Low levels of some microorganisms that are present in oral solid dosage forms are unlikely to present a risk to patients. The amount of water activity in these products can help determine when microbiological testing should be conducted.

A combination of security technologies, infrastructures, and cryptographic product-services families can help companies satisfy the requirements of 21 CFR Part 11.

FDA's Center for Drug Evaluation and Research is driving efforts toward creating initiatives to streamline regulatory processes, speed up drug production, and reduce costs.

Computational fluid dynamics can be a valuable tool for analyzing the efficiencies and performances of process equipment, which can lead to potential cost savings.

Participants at a Pharmaceutical Research and Manufacturers of America workshop share their views about the acceptable analytical practices of conducting forced degradation studies.

The author discusses current economic times and conditions for large pharmaceutical companies.

By optimizing formulation and process varibles, pellets can be prepared that can release a poorly soluble drug for 12-24 h following zero-order kinetics.