OR WAIT null SECS
September 01, 2011
The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.
Clarifying GMPs for excipients used as actives.
August 02, 2011
The authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.
O-arylation and O-alkylation, a one-pot protein synthesis, a combined approach in continued and chemocatalysis, and green-chemistry applications are the target of some recent advances in API synthesis.
Terry Novak, president of Norwich Pharmaceuticals, on recent industry trends.
August 01, 2011
The article examines a cross-functional supplier integration model to facilitate project management.
Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.
The article examines the drivers of customer perception of contract service providers of pharmaceutical development and manufacturing.
An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.
July 02, 2011
FDA, in cooperation with IPEC, is building a spectral library of excipients to detect improper ingredients within a drug product on site.