Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals. There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines. This edition contains chapters discussing the unique requirements for the universal critical quality a...

This collection of twelve short stories and one essay by Vietnamese writers reveals the tragic legacy of Agent Orange and raises troubling moral questions about the physical, spiritual, and environmental consequences of war.Between 1962 and 1971, the U.S. military sprayed approximately twenty million gallons of Agent Orange and other chemical defoliants on Vietnam and Laos, exposing combatants and civilians from both sides to the deadly contaminant dioxin. Many of the exposed, and ...