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Memoirs from IFPAC 2012 Sampling at IFPAC: Will Pharma Move to Large N? IFPAC 2012: The Club Opens Up Peeling Back the Layers: FDA Posts Case Study on Modified Release Dosages Case Studies: Multivariate Analysis at Novartis
 
Memoirs from IFPAC 2012

Memoirs from IFPAC 2012

Contributor Emil Ciurczak gives a session-by-session account of last week's IFPAC meeting in Baltimore. It was, he says, not the usual "Trust me; it works!" type of meeting about PAT and QbD.

Sampling at IFPAC: Will Pharma Move to Large N?

Sampling at IFPAC: Will Pharma Move to Large N?

Will the move to PAT push pharma to more robust sampling?

IFPAC 2012: The Club Opens Up

IFPAC 2012: The Club Opens Up

If this conference was any indication, maybe more people are starting to see the benefit of modern control, and the three-letter acronyms are taking on new forms, PAT morphing into smarter process validation and QbD, into process knowledge. And wasn't that the goal anyway?

Peeling Back the Layers: FDA Posts Case Study on Modified Release Dosages

Peeling Back the Layers: FDA Posts Case Study on Modified Release Dosages

The document is daunting (159 pages) but wonderfully detailed and descriptive.

Case Studies: Multivariate Analysis at Novartis

Case Studies: Multivariate Analysis at Novartis

A new article sheds light on how Novartis is using PAT tools and multivariate data analysis in pharma and biopharma operations.

The Regulatory Walls Are Falling Down

The Regulatory Walls Are Falling Down

10 January 2012

Optimistic opinions on the state of regulatory harmonization, courtesy of Sparta Systems’ K.R. Karu.

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Posted in Opinion Editorial0 Comments

Simulation and Modeling: Is Pharma Light Years Behind Aerospace?

Simulation and Modeling: Is Pharma Light Years Behind Aerospace?

09 January 2012

If the drug industry is to take its moonshot, does it need its own NASA? A blogger says pharma simulation and modeling efforts pale when compared to aerospace, and explains why.

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Posted in Opinion Editorial, Readers' Choice0 Comments

Q-IWG Releases Three More “Points to Consider” Documents

Q-IWG Releases Three More “Points to Consider” Documents

14 December 2011

The ICH Quality Implementation Working Group puts forth more documents to help industry flesh out and implement pharmaceutical Quality by Design.

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Posted in QbD News0 Comments

Rethinking Time to Market

Rethinking Time to Market

09 December 2011

QbD “isn’t about getting to market fast,” writes J. Paul Catania. “QbD is about getting to market reliably."

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Posted in Expert Insights, Readers' Choice0 Comments

Pharma’s R&D Productivity Problem: “Worse Than We Thought”

Pharma’s R&D Productivity Problem: “Worse Than We Thought”

06 December 2011

Just how far has pharma R&D productivity fallen? According to a new report, very far indeed. We're in an "Era of Scarcity," and the way out is to rethink innovation and emphasize "smart" over "speed" in drug development.

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Posted in Expert Insights, Resources0 Comments

LinkedIn LookIn: Eavesdropping on QbD Conversations

LinkedIn LookIn: Eavesdropping on QbD Conversations

02 December 2011

Eavesdropping on some of the better QbD-related conversations happening on LinkedIn. Here are November's hot discussion threads.

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Posted in QbD News, Readers' Choice0 Comments

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