The author reviews the types of reference-standard materials used in drug-product manufacturing, discusses current regulatory requirements, and outlines a reference-standard qualification program. The ...
This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from ...
Announcement on Updates to Secondary Refined Lead Price Standards and Methodology [SMM Announcement]
SMM Announcement]Announcement on Updates to Secondary Refined Lead Price Standards and Methodology On August 29, 2025, the ...
When patent protection for Lipitor expired in November 2011, generic drug manufacturers raced to capture a piece of the estimated $14 billion annual market for atorvastatin. Since 1996, Pfizer made ...
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