Displaying 1–19 of 19 results for Emil W. Ciurczak, Cadrai Technology Group

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Therapeutic Dose: The Importance of Design Qualification

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The DQ is a critical, yet often overlooked part of the process of developing and validating any new pharmaceutical PAT process. It is a strategically important time, where process engineers, material scientists and physical chemists can get together to develop meaningful materials ...

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: Buying Sneakers Isn’t Running the Marathon

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Columnist Emil Ciurczak cautions that it’s time for the pharma industry to emphasize the “P,” and de-emphasize the “A” and the “T” in PAT

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?

Therapeutic Dose: Avoiding the “Cool Hand Luke” Effect

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Loners make for fascinating drama, but they’ll doom any process analytical technology (PAT) project. Triage and communication are essential, Ciurczak argues, and cross-functional training’s value can far exceed its costs.

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?

Silencing the cGMP Priesthood

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cGMPS are essential, but when cGMP dogma triumphs over common sense and prevents innovation, we’re all in trouble, says NIR expert and pharmaceutical industry consultant, Emil Ciurczak. He offers some tips for drawing the line between compliance and absurdity.

PAT in Perspective: Are We Being Spoiled by Success and the Internet?

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NIR expert Emil Ciurczak thinks prosperity and the Internet are making today's graduates far too complacent and out of touch for their own good. Networking and professional societies are at risk, he says, and drug manufacturing will be worse off for it.

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.

PAT in Perspective: “One Size Fits All” Software May Not Fit PAT

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Beware of process control software that is not PAT-specific, cautions Emil Ciurczak. He cites Excel, with its rounding errors, as a prime example of software written without the input of “science-types.”

PAT in Perspective: Give Credit Where Credit is Due

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PAT and analytical services don’t always mix, as PAT columnist Emil Ciurczak relates. His advice: Don’t allow your PAT group to become a stepchild. Ensure that it receives credit for PAT-based improvements.

Ciurczak Analyzes IFPAC '06

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NIR expert and Pharmaceutical Manufacturing columnist Emil Ciurczak discusses this year's conference in this downloadable audio file. For his article discussing highlights and key developments, see "IFPAC 2006 Under the Microscope."

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 in Perspective: Headcount and PAT—Fact and Fiction

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Attention, corporate bean counters: PAT is not a magic bullet for reducing QC headcounts. In fact, it may require hiring more people, but the efforts will pay off in improved efficiencies and lower costs.

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.

PAT in Perspective: Estimate PAT’s Real Costs

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Don’t be “penny-wise but pound-foolish” during early planning and budgeting stages, and never base decisions on equipment sticker prices without considering savings in time to market.

PAT in Perspective: To Outsource or Not to Outsource . . .

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Pharmaceutical processing & engineering: A consultant ponders the question, as it relates to NIR and pharmaceutical process analytical technology (PAT) projects that require a high level of hard-to-find technical expertise.

PAT in Perspective: Preaching to the Wrong Choir

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Pharmaceutical processing & engineering: Last year at the IFPAC conference, NIR guru Emil Ciurczak bemoaned the fact that PAT was being promoted by geeks for geeks. Now, however, he notes that an upcoming summit may lead the charge toward a new emphasis on convincing corporate and financial ...

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