Drug Development

Articles

When I run a small production batch of a particular formulation with the same tablet press used to develop it, I get compressibility and disintegration issues. What am I doing wrong?

Scaling Up a Tableting Process

Letting contamination build up can cause multiple headaches.

Time is of the Essence

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

Knowing is Half the Battle

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.

FDA Perspectives: Understanding Challenges to Quality by Design

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

API Purification

Visiting a new site or going down memory lane may not get you where you want to go.

Movin' On Out

Quality management requires more effort in a complex supply chain.

Has Outsourcing Derailed PAT and QbD?

Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.

A Pharma Manufacturer's View of Quality by Design

The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.

Managing Technology Transfer: Developing a Complete CMC Package for an In-Licensed Product

An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.

Process and Scaling