PharmaQbD

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

paulthomas — Thu, 19 Jan 2012 17:31:43 +0000

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

Case Studies: Multivariate Analysis at Novartis

paulthomas — Tue, 17 Jan 2012 21:57:53 +0000

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?

paulthomas — Fri, 13 Jan 2012 15:20:15 +0000

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.

The Regulatory Walls Are Falling Down

paulthomas — Tue, 10 Jan 2012 17:57:39 +0000

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

Simulation and Modeling: Is Pharma Light Years Behind Aerospace?

paulthomas — Mon, 09 Jan 2012 18:36:47 +0000

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.

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

paulthomas — Wed, 14 Dec 2011 20:51:04 +0000

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

Rethinking Time to Market

paulthomas — Fri, 09 Dec 2011 16:00:26 +0000

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

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

paulthomas — Tue, 06 Dec 2011 17:02:26 +0000

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.

LinkedIn LookIn: Eavesdropping on QbD Conversations

paulthomas — Fri, 02 Dec 2011 19:09:04 +0000

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

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

paulthomas — Tue, 29 Nov 2011 19:43:24 +0000

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