Pharmaceutical Technology-07-02-2006

Pharmaceutical Technology
From The Editor

July 02, 2006

From RFID and pedigrees to PAT and process understanding, industry professionals are eying the growing gap between ambitious high-level guidance and current practice, and wondering how they can bridge this new space and keep in compliance with the untested rules.

Pharmaceutical Technology
Outsourcing

July 02, 2006

China is on the rise as a center for pharmaceutical R&D, but companies are still getting their footing for operating in China and the services industry has some maturing to do.

Pharmaceutical Technology
Washington Report

July 02, 2006

FDA is conducting laboratory research to understand better the ability of preclinical screening tests to identify potential risks and toxicities of nanotechnology-based drugs.

Pharmaceutical Technology

Select large custom manufacturers expand capacity, private equity firms buy companies in transition, and players from India and China build their positions.

A cleverly developed patent portfolio can block or minimize competition long past a patent's 20-year lifespan.

Pharmaceutical Technology

Pharmaceutical Technology provides perspective on pharmaceutical manufacturing activity, assessing the product portfolios, prescription volumes, revenues, and capital spending plans of more than 500 drug-makers. Novartis leads in diversity, with 889 products; Pfizer leads in number of scrips (352 million) and revenue ($44 billion). And generics companies are coming up on the inside.

In the Field
Pharmaceutical Technology

July 02, 2006

Pharmaceutical Science & Technology News

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.

Pharmaceutical Technology
Agent-In-Place

July 02, 2006

My audit host clearly knew and lied about the planned changes.

Pharmaceutical Technology
This Time Around

July 02, 2006

We can learn a lot about today's regulatory environment as a whole if we take it all in.