Tag: cross-contamination
Contamination Controls: Preventing Adulteration in Generic Drug Manufacturing
Contamination controls in generic drug manufacturing prevent harmful residues and microbes from entering medicines. Learn how cleanrooms, real-time monitoring, and human factors impact drug safety-and what’s changing by 2025.
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Published ON: 9 DecPatent exclusivity and market exclusivity are two different legal tools that protect new drugs. One comes from the patent office, the other from the FDA. Understanding the difference explains why drug prices stay high-and who controls when generics arrive.
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Published ON: 1 DecReplicate study designs are essential for assessing bioequivalence of highly variable drugs. Learn how full and partial replicate methods reduce sample sizes, meet regulatory standards, and improve generic drug approval rates.
Published ON: 2 DecContamination controls in generic drug manufacturing prevent harmful residues and microbes from entering medicines. Learn how cleanrooms, real-time monitoring, and human factors impact drug safety-and what’s changing by 2025.
Published ON: 11 Dec