Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products
The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.
Articles in this issue
Correcting the Course
Using Extrusion-Spheronization to Develop Controlled-Release Formulations of Azithromycin
Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products
February 2005
Good Work and True: USP Prepares for Convention 2005
Contract Manufacturers Getting Squeezed
In the Spotlight-February 2005
Emerging Analytical Technology: Moving from the Lab to the Line
Drug Safety Fears May Limit Reimporting and Shape R&D
In Defense of USP Singlet Testing
