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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Cmax and AUC are the two key pharmacokinetic measures used to prove generic drugs work the same as brand-name versions. Cmax shows peak concentration, while AUC measures total exposure. Both must fall within 80%-125% of the original for approval.
Published ON: 30 DecThe first generic drug company to file a patent challenge gets 180 days of exclusive sales rights. But this rule, meant to lower drug prices, is often manipulated-delaying competition and keeping patients from affordable medicines.
Published ON: 15 DecPost-market surveillance uncovers hidden side effects of drugs and medical devices after approval, using real-world data from millions of users. Learn how systems like MedWatch and AI-powered analytics catch dangers clinical trials miss.
Published ON: 5 DecDrug interactions occur when medications, foods, or health conditions change how a drug works in your body-potentially causing serious harm or reducing effectiveness. Learn what causes them, who's at risk, and how to prevent dangerous combinations.
Published ON: 3 DecLithium carbonate generics require careful serum level monitoring due to their narrow therapeutic window. Switching between brands can alter blood levels, risking toxicity or relapse. Learn safe targets, testing schedules, and how to avoid dangerous interactions.
Published ON: 1 Dec