Drug Development

Angie Drakulich was editorial director of Pharmaceutical Technology.

Articles

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

USP Opens Door to Pending Monographs for Excipients

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

SOCMA Issues API Quality-Agreement Template

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

The biotechnology markets in the United States, Europe, and Canada, and Australia reached aggregate profitability in 2009, according to Ernst & Young.

US, European, Canadian, and Australian Biotechnology Markets Reach Aggregate Profitability in 2009

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

Week Of May 3, 2010: Company And People Notes: FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

Michelle Hoffman, editorial director of Pharmaceutical Technology.

FDA wants industry to talk to them about the science underlying process innovations-really.

A Very Brady FDA

Chemocatalysis and biocatalysis are important elements of an effective strategy for improving yield and stereoselectivty.

Exploring Catalysis in API Synthesis

The growth of Brazil's generic-drug market is on a fast track, but what are the projections for the sector's future?

Report from Brazil May 2010

Enterprise-Level Change Control

When vessels, seals, and cooling units go haywire, operators must get in the mix.

Ingredients