Drug Development

Articles

The author describes key considertions for a complete risk-assessment model and provides insight into a pending IPEC guideline in this area.

Risk Assessment for Excipients for Enhanced Patient Safety

Many facilities buy compressed gas tanks or evaporate liquid nitrogen to supply processes with dry, high-purity nitrogen. An in-house nitrogen generator, however, provides several significant benefits.

In-House Nitrogen Generation Can Enhance Safety and Decrease Costs

The authors investigated the tableting properties of PanExcea MHC300G, a high-performance excipient.

Evaluation and Characteristics of a New Direct Compression Performance Excipient

A new audit guide aims to improve supply-chain security and supplier qualification practice.

Inside IPEC: IPEC–Americas Releases Good Distribution Practices Audit Guide

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The power of emerging markets is reflected in the pharma's sales and production positions.

A Focus on Emerging Markets

Will 2011 be a more promising year for new molecular entities? A review of Big Pharma's late-stage pipeline shows what might lie ahead.

Evaluating Late-Stage Pipelines and Potential

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

What's More Important, the Process or the Product?

During the past few years, we've seen a growing interest in direct oral application products, evidenced by the large amount of products already available on the market.

Using Excipients In Powder Formulations

Iain Moore explains what progress has been made so far regarding EU plans to regulate excipients.

An Update On The EU's Plans For Excipient Regulation

Biologics are large molecular weight molecules primarily formulated for parenteral administration; however, there are some smaller biomolecules that have been formulated for oral use.

APIs and Excipients