Displaying 126–150 of 156 results for USP

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PAT in Perspective: Safe? Yes. Effective? Not So Much.

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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.

Therapeutic Dose: Avoiding "Cool Hand Luke" Syndrome: Part II

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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?

Understanding Variability, its Sources and its Impact on the Pharma Supply Chain

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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.

PAT in Perspective: Drugs Are Not Potato Chips

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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?

Dismantling the Gray Maze

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A bureaucratic drug regulatory system — once referred to as a “gray maze” — has long isolated the world’s second largest pharmaceutical market from the rest of the world. Japan’s regulators are moving toward an international, science-based framework. Can they move fast enough? Agnes Shanley talks...

Aseptic Processing, the Japanese Way

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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 Biken’s vaccine facility for a look at what the future may have in store for more ...

PAT in Perspective: Do We Need Final Release Tests with PAT?

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NIR expert Emil Ciurczak asks whether PAT will eliminate the need for traditional USP product release tests…and concludes that they’re still essential as a reference method and important in minimizing liability.

Chromatography Roundup

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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.

Could Your Next Employer Be Based in India?

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A skilled and tenacious workforce is allowing India to expand globally and move rapidly into R&D.

USP India’s New Facility Opens its Doors

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AstraZeneca India's former president oversees the operation, which includes a business office and testing laboratories.

Will USP and FDA Reach Consensus on Stability Testing?

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Editor in Chief Agnes Shanley observes that standards will guide drug manufacturing's future, if everyone can agree on what's important.

IFPAC 2006 Under the Microscope

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"NIR person" and physical chemist Emil Ciurczak provides a thorough analysis of this year's IFPAC conference, held Feb. 21-23 in Arlington, Va.

PAT: The Cat’s Out of the Bag

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FDA’s Watts and Afnan assured us that PAT is in good hands — the industry’s.

Interphex 2006 Preview: The Best of the “Phex”

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This year's event builds upon the success of the 2005 show, with increases in both exhibitors and educational sessions.

Rapid Microbiological Methods for a New Generation

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These are exciting times, says author Michael J. Miller, as 19th-century microbiological methods make way for rapid detection, quantification and characterization technologies.

What is Advanced Aseptic Processing?

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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 Future of Barrier Packaging

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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.

Putting WFI to Work in Juncos

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Amgen process engineers share Water-for-Injection expertise from the ever-expanding facilities in Juncos.

IQPC’s Philly Conference Focuses on ROI, Management Issues

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Emil Ciurczak reviews December’s conference, which broke with tradition by focusing more on the business than the technical side of PAT.

Applying PAT Principles to Blister Packaging

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FEA Modeling, 3-D Scanning, and SEM are all part of a “right first time” approach to pharmaceutical packaging.

The Desired State: PAT and the Road to Enlightenment

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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.

Events Calendar

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Drug Industry Calendar: When and where are the key conferences, excellent expos and seminal seminars in the pharmaceutical industry? Find out here!

Nutri Granulations: Validating the Team Concept

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At Nutri Granulations, a team of 20 runs an entire drug-licensed facility — and loves it.

Assure Batch Uniformity for Freeze-Dried Products

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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.

Explorations in Effusivity

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