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No More Tire Kicking: Chris Amstutz Shares Views on PAT’s Expansion Welcome ICH Q11 Framing a QbD Design Space with Tolerance Intervals Can QbD Get Its Definitions Straight?
 
No More Tire Kicking: Chris Amstutz Shares Views on PAT’s Expansion

No More Tire Kicking: Chris Amstutz Shares Views on PAT’s Expansion

There's been a shift in the industry in the past 18 months, says Emerson's life sciences expert, from experimentation to broad implementation.

Design of Experiments Helps Boost Key Intermediate Yield by 18%

How recent design of experiments work at Codexis Labs in Singapore led to an 18% increase in yield of a key intermediate.

Welcome ICH Q11

Welcome ICH Q11

The final document, pertaining to the development and manufacture of drug substance, is now available and moves Q11 into its implementation phase.

Framing a QbD Design Space with Tolerance Intervals

Framing a QbD Design Space with Tolerance Intervals

Via the response surface method, more conservative tolerance intervals can be imposed, and a more robust design space achieved. Mark Anderson of Stat-Ease demonstrates how.

Can QbD Get Its Definitions Straight?

Can QbD Get Its Definitions Straight?

After all these years, wonders Emil Ciurczak, why is there still so little agreement on basic terminology?

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

Pharma Faces a New Year: Will it Mirror, or Break Away From, the Past?

Pharma Faces a New Year: Will it Mirror, or Break Away From, the Past?

29 November 2011

Effective change in the pharmaceutical industry must improve business performance, and not just a process. Ali Afnan anticipates what must happen in 2012.

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Posted in Expert Insights, Opinion Editorial1 Comment

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