Facing still-sluggish market conditions and a changing world order in fine chemicals, the large Western custom manufacturers are responding by building their toolboxes in specialized technologies in chiral chemistry, catalysis, and biosciences and by adjusting their manufacturing networks via streamlining or investment in Asia.
Flu vaccines. Dow veterinary vaccine made in plants. $1.95 billion FDA budget focuses on high-profile programs. Non-injectable insulins win approval. FDA releases guides to dissolution testing, quality overall summary, and new drug-label formats.
Adding a cleaning step to the field-testing protocol, and combining it with the data generated to register sanitizing and disinfectant agents under FIFRA and the CEN TC 216 work program, produces a sanitation-and-disinfection validation methodology that is cost-effective, simple, and time-saving.
Polymorph farming on a chip is a promising strategy for rapid polymorph discovery by transforming crystallization?crystal isolation?characterization into one time-efficient step.
A modified modular high-pressure system can form nanosuspensions of model compounds by individually controlling cavitation, impact, and shear forces.
Quantitative data from the literature show strong relationships among average particle size, powder densification, tensile strength, and hardness.
Madness in March: lost ingredients, missed lot numbers, and a million-dollar photo.
USP's proposed General Chapter 1226 "Verification of Compendial Procedures" aims to provide guidance about the verification process.
Transdermal matrix-type patches of Nefopam hydrochloride with a combination of pressure-sensitive adhesives were developed. The polymeric composition provided a controlled and sustained release of the drug from the patches and demonstrated favorable physicochemical characteristics.
Pharmaceutical companies are seeing the development process in a new way, and that has major implications for service providers.
Analytical tools and methods that require less water and detergent are gaining interest for faster, more efficient cleaning.
The authors encourage the investigation into whether the occurrence of grow-through and the diminution in the size of certain organisms when in contact with given liquids are the same phenomenon manifested under different circumstances.
PDA's Technical Report No. 39 provides guidance for protecting temperature-sensitive products.
A new FDA policy emphasizes quality control over GMP compliance in producing clinical trial supplies.
Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for both regulatory and production purposes. This article describes one approach to identifying and validating the materials used in a disposable filling process.
FDA's 2007 budget request funds homeland security and pandemic preparedness by reducing support for the agency’s core mission.
Secondary sensors help protect feedback control systems from the effects of sensor drift.
The outcomes of complex chains of reactions are hard to predict. Hindsight being 20–20, I can tell you that implementing the prohibition of alcohol in the 1920s-which was intended to reduce corruption and social problems, but actually lead to a rise in organized crime-was a bad idea.
