Richard Jaenisch weighs how FDA's new NAM rule could reshape preclinical testing and what CMC teams should do now, on Manufacturing Intelligence.
News|Articles|July 15, 2013
- Pharmaceutical Technology-07-15-2013
- Volume 2013 eBook
- Issue 1
Characterization with Atomic Force Microscopy, Topographic, and 3D Raman
The authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample.
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Highly specified drug-delivery systems require specific quality evaluation during the development stage. The authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample three-dimensionally, underneath, and at the surface in a nondestructive manner.
Articles in this issue
about 13 years ago
Identification and Quantification of Trace-Level Protein Impuritiesabout 13 years ago
Ultra-High-Speed Analysis of Ibuprofen Using HPLCAdvertisement
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In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss the implementation of risk-based approaches for CMC.
Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
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