Quality Systems

Articles

The authors discuss the statistical tools used in experimental planning and stategy and how to evaluate the resulting design space and its graphical representation.

Statistical Considerations in Design Space Development (Part II of III)

In 2009, the European Commission (EC) Customs Union seized 11,462,533 medicines and medical products for suspected violations of intellectual property (IP), according to the Commission's annual report on EU Customs Enforcement of Intellectual Property Rights, which was published last week.

European Commission Releases Report on Customs Interventions

Angie Drakulich was editorial director of Pharmaceutical Technology.

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced earlier this week that John J. Castellani will replace Billy Tauzin as President and Chief Executive Officer.

Castellani to Replace Tauzin as Head of PhRMA

Podcasts

Podcast: Powder Dynamics and QbD

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

A Technical Forum featuring representatives from Dow Chemical, ISP, and DMV-Fonterra Excipients. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Applying QbD to Excipient Formulation and Development

The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Flexible Approaches to Accommodate Excipient Variability Using the Principles of QbD

INTERPHEX 2010 will take place this week at the Jacob K. Javits Center in New York.

INTERPHEX Comes to New York

President Obama signed into law major healthcare reform following the passage of the bill by the House of Representatives.

Healthcare Reform Draws Mixed Reviews from Pharmaceutical and Biotechnology Industries

In the final phase of its transparency initiative, the US Food and Drug Administration seeks additional public comments about how it can increase its interactions with regulated industry.

FDA Transparency Initiative Moves to Phase Three

The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.

Quality by Design