Pharmaceutical Technology-09-02-2011

The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.

A Q&A with John Plachetka, chair, president, and CEO of POZEN, on recent industry trends.

A new, robust method for protein elution from ceramic hydroxyapatite.

PDUFA renewal legislation sets stage for new policies affecting revenue, resarch, and oversight.

Being aware of a forthcoming inspection or how a product was made can make a huge difference.

A report commissioned by FDA evaluates the QbD program.

Internal and external Web-based communities are changing how pharma companies can innovate.

Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.

Growth and change in Brazil and Mexico offer key opportunities for the region's pharmaceutical industry.

The EU debt crisis portends of possible negative repercussions for the dose CMO industry.

The author offers perspectives on ways in which pharmaceutical companies and other stakeholders in the supply chain can confront the threat of counterfeit products, cargo theft, illegal diversion, and economically motivated adulteration.

Smartphones could become the product-authentication tool of choice. Contains online bonus material.

A summary of the latest steering committee and expert working groups' meeting.

Might European officials reverse their position on acceptable production methods?

Reauthorization of pediatric exclusivity provisions looms in 2012 and debates begin anew.

International Federation of Pharmaceutical Manufacturers and Associations takes global action to improve public health.

Industry buy-in is increasing as pharma companies proceed with select projects and research.

New product reviews for September 2011 focusing on manufacturing.

Researchers at MIT and Harvard University report on new methods for producing microscale hydrogels.

After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.

The third in a series of eight case studies from the Product Quality Research Institute focuses on facility biocontainment and inactivation.

Biocatalysis, chemocatalysis, and other chiral technologies continue to attract the investment dollars of CMOs and fine-chemical companies.

Click the title above to open the Pharmaceutical Technology September 2011 issue in an interactive PDF format.