Tag: AUC

Cmax and AUC in Bioequivalence: What Peak Concentration and Total Exposure Really Mean

Cmax and AUC in Bioequivalence: What Peak Concentration and Total Exposure Really Mean
Posted by: Dorian Wellings in: Health and Medicine
30 Dec | 12:05 PM

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.

read more
Go!

recent posts

What Are Drug Interactions and Why They Matter for Medication Safety
What Are Drug Interactions and Why They Matter for Medication Safety

Drug 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 Dec
Replicate Study Designs for Bioequivalence Assessment: Advanced Methods for Highly Variable Drugs
Replicate Study Designs for Bioequivalence Assessment: Advanced Methods for Highly Variable Drugs

Replicate 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 Dec
Sleep Hygiene When Medications Disrupt Rest: Practical Steps to Reclaim Your Nights
Sleep Hygiene When Medications Disrupt Rest: Practical Steps to Reclaim Your Nights

Learn how to fix sleep disrupted by medications without adding more pills. Practical, science-backed sleep hygiene steps that work even when drugs interfere with your rest.

Published ON: 17 Dec
Documentation Requirements for Recording Generic Substitution Decisions in Pharmacy Practice
Documentation Requirements for Recording Generic Substitution Decisions in Pharmacy Practice

Learn the essential documentation requirements for recording generic drug substitutions in pharmacy practice. Understand state laws, what to log, common mistakes, and how to avoid errors that impact patient safety.

Published ON: 1 Dec
How to File a Direct Complaint with the FDA as a Patient
How to File a Direct Complaint with the FDA as a Patient

Learn how patients can file direct complaints with the FDA about adverse reactions, product failures, or safety issues with drugs, devices, and supplements. Step-by-step guide on using MedWatch and the Safety Reporting Portal.

Published ON: 25 Dec

categories

archives

tags

dietary supplement online pharmacy drug interactions health benefits medication safety generic drugs side effects dietary supplements physical therapy FDA MedWatch connection erectile dysfunction gut health management treatment role weight loss next big thing pain relief heart health