FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|February 1, 2003
- Pharmaceutical Technology-02-01-2003
- Volume 2003 Supplement
- Issue 1
Understanding and Implementing Efficient Analytical Methods Development and Validation
Author(s)Jay Breaux, PhD
Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.
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Articles in this issue
over 23 years ago
Implementing Successful Stability Testing Operationsover 23 years ago
Choosing a Contract Research Organization for Analytical Testingover 23 years ago
Challenges, Considerations, and Benefits of Raw Materials TestingAdvertisement
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