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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 Can Regulatory Harmonization Be More Effective, and Equitable?
 
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.

Can Regulatory Harmonization Be More Effective, and Equitable?

Can Regulatory Harmonization Be More Effective, and Equitable?

A new not-for-profit will champion global regulatory “capacity building,” and aims to correct what it views as failures by the established international regulatory community to address the needs of business and emerging nations.

Sampling at IFPAC: Will Pharma Move to Large N?

Sampling at IFPAC: Will Pharma Move to Large N?

27 January 2012

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

Read the full story

Posted in QbD News0 Comments

IFPAC 2012: The Club Opens Up

IFPAC 2012: The Club Opens Up

27 January 2012

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?

Read the full story

Posted in Opinion Editorial, QbD News0 Comments

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

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

19 January 2012

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

Read the full story

Posted in QbD News, Resources0 Comments

Case Studies: Multivariate Analysis at Novartis

Case Studies: Multivariate Analysis at Novartis

17 January 2012

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

Read the full story

Posted in Expert Insights, Resources0 Comments

Can Regulatory Harmonization Be More Effective, and Equitable?

Can Regulatory Harmonization Be More Effective, and Equitable?

13 January 2012

A new not-for-profit will champion global regulatory “capacity building,” and aims to correct what it views as failures by the established international regulatory community to address the needs of business and emerging nations.

Read the full story

Posted in Opinion Editorial, QbD News0 Comments

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.

Read the full story

Posted in Opinion Editorial0 Comments

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