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Tag: bioequivalence
Cmax and AUC in Bioequivalence: What Peak Concentration and Total Exposure Really Mean
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Cmax and AUC are the two key pharmacokinetic measures used to prove generic drugs work like brand-name versions. Cmax shows peak concentration, AUC shows total exposure-both must fall within 80%-125% for approval.
Therapeutic Failures: When a Generic Drug Doesn't Work as Expected
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Generic drugs are supposed to be safe and effective alternatives to brand-name medications, but when they fail to work as expected, the consequences can be serious. Learn why some generics don't deliver the same results-and what you can do about it.
Medical Education on Generics: Do Doctors Learn Equivalence?
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Doctors prescribe generics for 90% of medications, but many lack training on bioequivalence. Learn why knowledge gaps persist, how real-world feedback changes prescribing, and what's being done to fix it.
Modified-Release Formulations: Key Bioequivalence Requirements You Need to Know
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Modified-release formulations require special bioequivalence testing to ensure generics work as safely and effectively as brand-name drugs. Learn the key regulatory requirements, common pitfalls, and why standard tests aren't enough.
