Drug Development

Articles

We're all familiar with traditional pills and medicines, but how about medicated chewing gum? Marc Ribe of Cafosa Gum explains how APIs can be incorporated into a novel dosage form that can aid patient compliance.

Chewing Over API Challenges

Angie Drakulich was editorial director of Pharmaceutical Technology.

Clarifying GMPs for excipients used as actives.

Atypical Actives Gain Attention

A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.

Addressing Ways to Improve Supply-Chain Security: A Perspective from Pfizer

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.

The Determination and Control of Genotoxic Impurities in APIs

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

A perspective from Pfizer on the lessons from small-molecule manufacturing that can be applied to biomanufacturing.

Manufacturing Perspectives: Lessons for Biomanufacturing from Small-Molecule Manufacturing

The author examines sample-preparations methods used in inductively coupled plasma–optimal emission spectroscopy for four test metals.

Sample Preparation for Quantitative Metal Impurity Testing

Achieving a consistent level of quality control could greatly reduce waste and save money for the pharmaceutical industry. But why has talk about Six Sigma died down at a time when it could be of great benefit?

Is Six Sigma Still Relevant for Drugmakers?

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The Society for Chemical Manufacturers & Affiliates commented on EPA's modifications to the Inventory Update Reporting rule, also broadly know as the Chemical Data Reporting rule. EPA issued the final rule earlier this month.

SOCMA Comments on EPA's Chemical Data Reporting Rule

Merck & Co. announced last week that it plans to reduce its global workforce, as measured by year-end 2009 levels, by an additional 12–13% by 2015. The company made the announcement as part of its second-quarter earnings release, which the company issued on July 29, 2011.