Drug Development

Articles

UK MHRA Okays Chiron Flu Vaccine Plant; FDA Approval Still to Come

FDA Approves Treatment for Smallpox Vaccination Side Effects

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients

In this time of liability reform, pharma deserves the chance to align its economic interests with its ethical obligations to the patient.

A “Disclosure Defense” in Liability Law

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.

Validating Automated Systems

The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study.

Implications of Photostability on the Manufacturing, Packaging, Storage, and Testing of Formulated Pharmaceutical Products

The author reviews dimensional analysis as a straight-forward approach to scale up.

How to Scale Up Scientifically

Bernard A. Olsen, PhD, is a research fellow at Lilly Research Laboratories, Eli Lilly and company, 1650 Lilly Road, DC TL12, Lafayette, IN 47909, tel. 765.477.4923, olsen_bernard_a@lilly.com.

The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.

Developing and Using Analytical Methods to Achieve Quality by Design and Efficiency in Drug Development

The author points out some major obstacles to effective scale-up and describes methods available to pharmaceutical scientists for addressing scalability issues.

Scale Up of Liquid and Semisolid Manufacturing Processes

In the manufacture of many pharmaceutical products, dry-particle blending is a critical step that directly affects content uniformity.

Process and Scaling