Displaying 126–150 of 156 results for USP
PAT expert Emil Ciurczak points out that a repository of methods and standard practices, terms, units, etc. is critical to understanding (and thus controlling) the process of producing good, predictable, and reproducible solid dosage forms.
At a time when the amount of available data is increasing exponentially, why are we isolating ourselves from our brethren and the larger scientific community?
How one pharmaceutical company used the fundamentals of variability analysis to analyze release and stability failures, gain control of its supply chain, and save millions of dollars by identifying and eliminating the causes of those failures.
Although PAT and technologies like NIR are important, there still are things that they cannot do, concedes NIR expert Emil Ciurczak. Are advocates within the industry suspending rational and much needed skepticism, he asks, when they talk about eliminating final product stability testing altogether?
A bureaucratic drug regulatory system once referred to as a gray maze has long isolated the worlds second largest pharmaceutical market from the rest of the world. Japans regulators are moving toward an international, science-based framework. Can they move fast enough? Agnes Shanley talks...
With inspired robotics and isolation technology, Japan is pushing the aseptic processing envelope. James Akers and colleagues from Shibuya and Handai Biken assess what sets Japan apart, and take us inside Handai Bikens vaccine facility for a look at what the future may have in store for more ...
NIR expert Emil Ciurczak asks whether PAT will eliminate the need for traditional USP product release tests and concludes that theyre still essential as a reference method and important in minimizing liability.
While truly groundbreaking innovations in chromatography equipment happen every blue moon, there have been noteworthy gradual improvements in the areas of chromatography media, column packing and on-line buffer blending. Managing Editor Paul Thomas provides the big picture.
A skilled and tenacious workforce is allowing India to expand globally and move rapidly into R&D.
AstraZeneca India's former president oversees the operation, which includes a business office and testing laboratories.
Editor in Chief Agnes Shanley observes that standards will guide drug manufacturing's future, if everyone can agree on what's important.
"NIR person" and physical chemist Emil Ciurczak provides a thorough analysis of this year's IFPAC conference, held Feb. 21-23 in Arlington, Va.
FDAs Watts and Afnan assured us that PAT is in good hands the industrys.
This year's event builds upon the success of the 2005 show, with increases in both exhibitors and educational sessions.
These are exciting times, says author Michael J. Miller, as 19th-century microbiological methods make way for rapid detection, quantification and characterization technologies.
Authors James Agalloco, James Akers and Russell Madsen argue that only technologies that eliminate direct contact with operators should be considered advanced if the term is not to degenerate into a commercial catch phrase.
The need for increased barrier properties and a right first time approach to packaging is driving new technologies and an open, scientific approach to design and implementation.
Amgen process engineers share Water-for-Injection expertise from the ever-expanding facilities in Juncos.
Emil Ciurczak reviews Decembers conference, which broke with tradition by focusing more on the business than the technical side of PAT.
FEA Modeling, 3-D Scanning, and SEM are all part of a right first time approach to pharmaceutical packaging.
Pharmaceutical processing & engineering: By focusing on the pharmaceutical manufacturing process, ASTM standards for process analytical technology (PAT) promise to bring engineering rigor and proactive decisionmaking to pharmaceutical quality.
Drug Industry Calendar: When and where are the key conferences, excellent expos and seminal seminars in the pharmaceutical industry? Find out here!
At Nutri Granulations, a team of 20 runs an entire drug-licensed facility and loves it.
Freeze drying: Successful lyophilization requires precise control of process conditions, extensive equipment testing, and analysis of bulk solution, dry and reconstituted product; surrogates can be used for some tests.