J Korean Med Assoc Search

CLOSE


J Korean Med Assoc > Volume 45(1); 2002 > Article
Journal of the Korean Medical Association 2002;45(1):65-72.
Published online August 10, 2016.
DOI: https://doi.org/10.5124/jkma.2002.45.1.65   
Bioequivalence Test and Its Significance
Kyung Hwan Kim
Abstract
Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar experimental conditions in either a single dose or multiple doses in an appropriately designed study. If a drug is to be bioequivalent to the reference drug, the confidence interval for both pharmacokinetic parameters, AUC(area under the plasma concentration-time curve) and Cmax(maximal plasma concentration), must be entirely within the 80% to 125% of those of the reference drug. Underlying the concept of bioequivalence is the thesis that, if a drug product contains a drug substance that is chemically identical and is delivered to the site of action at the same rate and extent as another drug product, then it is equivalent and can be substituted for that drug product. The primary concern from the regulatory point of view is the protection of the patient against approval of products that are not bioequivalent. In this paper the general concept and the practical significance of the bioequivalence is described. The recently revised Korean guideline for bioequivalence test is also discussed.
Key Words: Bioequivalence, Generic substitution, Korean guideline for bioequivalence
 
TOOLS
Share :
Facebook Twitter Linked In Google+ Line it
METRICS Graph View
  • 1 Crossref
  •   Scopus
  • 400 View
  • 0 Download
Related articles in
J Korean Med Assoc


ABOUT
ARTICLE CATEGORY

Browse all articles >

ARCHIVES
FOR CONTRIBUTORS
Editorial Office
Samgu B/D 7F, 40 Cheongpa-ro, Youngsan-gu, Seoul 04373, Korea
Tel: +82-1566-2844    Fax: +82-2-792-5208    E-mail: jkmamaster@kma.org                

Copyright © 2022 by Korean Medical Association.

Developed in M2PI

Close layer
prev next