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.
|Articles|October 2, 2003
- Pharmaceutical Technology-10-02-2003
- Volume 27
- Issue 10
Process Analytical Technology Concepts and Principles
Author(s)Mark L. Balboni
This article outlines the key concepts that define process analytical technology and emphasizes the relevant theory and applications of chemometrics.
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Articles in this issue
almost 23 years ago
Designing a New Drug Packagealmost 23 years ago
GMP Update: Reducing Obstacles to Innovationalmost 23 years ago
Filling the Void: PAT in a Connected Manufacturing Environmentalmost 23 years ago
October 2003almost 23 years ago
Outsourcing is Front Page News in 2003almost 23 years ago
October 2003almost 23 years ago
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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.
The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.
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.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
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