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February 01, 2006
Though dissolution testing has been under scrutiny, it is still a powerful test method.
Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study.
January 01, 2006
Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.
November 01, 2005
Coordinating validation efforts throughout an organization requires an accurate and timely overview and a validation master plan (VMP).
Risk analysis and evaluation of software and computer systems is a good tool to optimize validation costs by focusing on systems with high impact on both the business and compliance.
October 02, 2005
A radiotracer technique is a simple, fast, and sensitive technique for analyzing the integrity of clinical supply packages to water.
June 01, 2005
Glossary of computer and software terms.
March 02, 2005
As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.
February 02, 2005
Analytical instrument suppliers are developing manufacturing-tailored tools that are small, precise, and easy to use.
September 02, 2004
A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.
