The Journal of Clinical Pharmacology

http://jcp.sagepub.com/ Bioequivalence or Therapeutic Equivalence

SAGE Publications J Clin Pharmacol 1985 26: 1 The online version of this article can be found at: http://jcp.sagepub.com/content/26/1/1.citation

Published by:
http://www.sagepublications.com

On behalf of:

American College of Clinical Pharmacology

Additional services and information for The Journal of Clinical Pharmacology can be found at: Email Alerts: http://jcp.sagepub.com/cgi/alerts Subscriptions: http://jcp.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav

Downloaded from jcp.sagepub.com by ioana m on November 24, 2010

EDITORIAL

Bioequivalence Therapeutic

or Equivalence

recent increase in generic products and the economic pressures to reduce health care costs and thus mandate substitution laws have created a situation of considerable importance. These events may have outpaced the scientific communitys ability to carefully study the scientific indications. Clinical pharmacologists are well aware of difficulties in determining the bioavailability of generic as well as proprietary drugs. In fact, the concerns of the scientific community have been a principal impetus in the establishment of the bioavailability standards by the Food and Drug Administration. However, in the testing of generic products, bioequivalency studies are first conducted in vitro and then in healthy, young, male volunteers. This may not be an adequate evaluation. We are all aware of the possible exaggeration of pharmacokinetic differences in patients, especially in the elderly and those with impaired hepatic or renal function. When one deals with life-threatening conditions, pharmacokinetic differences in generic drugs may lead to serious clinical conseqUences. Additionally, the different excipients and binders that manufacturers of generic compounds use may yield untoward reactions in patients. To evaluate the possible pharinacokinetic differences in patients and also evaluate a drugs therapeutic equivalence, studies should be conducted expediently in patients and

T he

high-risk populations, such as elderly patients, approval is given to a generic compound. To evaluate the untoward reactions for excipients and binders, the clinical pharmacology community must take the lead in postmarketing surveillance. We hope that the brief reports section of THE JOURNAL OF CLINICAL PHARMACOLOGY will provide one forum for the timely reporting of such reactions. Generic drugs may offer a cOst advantage. In this era of spiraling health care #{244}osts, this is an important consideration. However, the health of our patients cannot permit a less-than-thorough evaluaticm of these new additions to the therapeutic armamentariurn. The challenge to the clinical pharmacologist is to insure that generic and proprietary drugs are truly therapeutically equivalent. We must form an adequate clinical information base so that we can make a scientifically reasonable assessment. Without this adequate supply of information, physicians treating patients cannot evaluate the therapeutic equivalence among the generics or between the generic and the proprietary product. We must know that in vitro bioequivalence is synonymous with clinical therapeutic equivalence. certain before John C. Somberg,

MD, FCP

Editor

EDITORIAL

Downloaded from jcp.sagepub.com by ioana m on November 24, 2010