This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|February 2, 2005
- Pharmaceutical Technology-02-02-2005
- Volume 29
- Issue 2
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.
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Articles in this issue
over 21 years ago
Correcting the Courseover 21 years ago
February 2005over 21 years ago
Good Work and True: USP Prepares for Convention 2005over 21 years ago
Contract Manufacturers Getting Squeezedover 21 years ago
In the Spotlight-February 2005over 21 years ago
Emerging Analytical Technology: Moving from the Lab to the Lineover 21 years ago
Drug Safety Fears May Limit Reimporting and Shape R&Dover 21 years ago
In Defense of USP Singlet TestingAdvertisement
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