(pharmacology)

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Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.[1] It is a standard measurement in pharmacokinetics. Cmax is the opposite of Cmin, which is the minimum (or trough) concentration that a drug achieves after dosing. The related pharmacokinetic parameter tmax is the time at which the Cmax is observed.[2]

After an intravenous administration, Cmax and tmax are closely dependent on the experimental protocol, since the concentrations are always decreasing after the dose. But after oral administration,Cmax and tmax are dependent on the extent, and the rate of drug absorption and the disposition profile of the drug. They could be used to characterize the properties of different formulations in the same subject.[3]

Short term drug side effects are most likely to occur at or near the Cmax, whereas the therapeutic effect of drug with sustained duration of action usually occurs at concentrations slightly above the Cmin.

The Cmax is often measured in an effort to show bioequivalence (BE) between a generic and innovator drug product.[4] According to the FDA, drug quality bioavailability (BA) and BE rely on pharmacokinetic measurements such as AUC and Cmax that are reflective of systemic exposure.[5]

References[edit]

  1. ^ Tracy TS (2004). "Pharmacokinetics". In Stitzel RE, Craig CF. Modern pharmacology with clinical applications. Hagerstwon, MD: Lippincott Williams & Wilkins. p. 49. ISBN 0-7817-3762-1. 
  2. ^ Amy Newlands. "Statistics and Pharmacokinetics in Clinical Pharmacology Studies" (PDF). 
  3. ^ Urso R, Blardi P, Giorgi G (March 2002). "A short introduction to pharmacokinetics". Eur Rev Med Pharmacol Sci. 6 (2-3): 33–44. PMID 12708608. 
  4. ^ Midha KK, Rawson MJ, Hubbard JW (October 2005). "The bioequivalence of highly variable drugs and drug products". Int J Clin Pharmacol Ther. 43 (10): 485–98. doi:10.5414/cpp43485. PMID 16240706. 
  5. ^ "Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations" (PDF). FDA. Retrieved 13 December 2013.