Video | Pharma QbD

Dr. Prabir Basu of NIPTE

Senior Editor Paul Thomas discusses education and training within the pharmaceutical industry with NIPTE Executive Director Dr. Prabir Basu.

Bayer's "Thinnest Needle" Combats MS Patients' Anxieties

Bayer HealthCare Pharmaceuticals Inc. today announced that Betaseron, its treatment for relapsing forms of multiple sclerosis (MS), will soon be available with a new 30-gauge needle, which will be the thinnest needle of any injectable disease-modifying therapy for people with MS.

Extending QbD to Patient Info: Pfizer's Web Site Focuses on Risk/Benefits and Drug Interactions

Pfizer's new Web site allows patients to check for drug interactions.

"PAT Talk": The Pharma Quality Lifeline

Pharma Quality is being redefined by ICH, linking quality to process efficiency. Now it must carry the industry into the era of personalized medicine. Tune in to Emil Ciurczak and Jack Carroll for some straight talk on benchmarking and legacies from Deming et al.

Video: Justin Neway on Process Development, QbD and Manufacturing

In this video interview taped at Interphex 2008, Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing with Editor-in-Chief Agnes Shanley.

Part Two: Justin Neway on Process Development, QbD and Manufacturing

In part two of a video interview taped at Interphex 2008, Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing with Editor-in-Chief Agnes Shanley.

Video: New Site Allows Patients To Research Drugs

Pfizer's new Web site allows patients to check for drug interactions.

What Do Pharmaceutical Manufacturers Really Need to Know about ICH Q8R?

Insights from our QbD Chat video series, with Bikash Chatterjee of Pharmatech Associates.

Got Goat? First Approved Drug from Engineered Animal

FDA recently approved the first biological product made from genetically engineered animals.

FDA's Helen Winkle on Quality by Design and the Need to Prioritize Information

At a panel discussion at Emerson's Users Exchange in September, Helen Winkle, Director of FDA's Office of Pharmaceutical Science at the Center for Drug Evaluation and Research, discussed the need for industry, and reviewers, to focus on information that is critical to product quality and safety.

Ali Afnan of FDA on QbD and the Need for New Science and a Change in Mindset

At a life sciences panel discussion during the 2009 Emerson Users Exchange, Ali Afnan, Senior Staff Fellow with the Office of Pharmaceutical Science, FDA's Center for Drug Evaluation and Research, discussed the issues slowing commercialization of drugs via QbD. It will take five to six years, he said, for drugs developed using a true QbD approach to reach the market.

Video: James Blackwell on QbD for Biopharmaceuticals

At Bioprocess International's 2009 conference, James Blackwell talked about QbD for smaller companies, and the importance of starting with the risk-management piece. Studying documented case studies from other industries can help professionals make a strong business case for QbD to senior management, he says.