We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Article |

White Paper on the Therapeutic Equivalence of Chemically Equivalent Drugs Prepared by a Subcommittee of the Policy Advisory Committee, Drug Efficacy Study

W. B. Castle, MD; E. B. Astwood, MD; Maxwell Finland, MD; Chester S. Keefer, MD
JAMA. 1969;208(7):1171-1172. doi:10.1001/jama.1969.03160070049012.
Text Size: A A A
Published online


Recent reports of considerable variation in the serum levels, and therefore in the probable biological activities, of equal doses of certain drugs marketed by different manufacturers, focus attention upon an important determinant of drug efficacy. These variations indicate that therapeutic equivalence, or equal biological activity, cannot necessarily be inferred from equivalence in the chemical constitution of different formulations of the same drug. In the Drug Efficacy Study, it has been found that, in many cases, no data bearing on biological activity of chemically equivalent drugs are available other than those submitted by the manufacturer who originally filed a New Drug Application for his product. For this reason, the following qualifying addendum was approved by the Policy Advisory Committee of the Drug Efficacy Study and was forwarded to the Food and Drug Administration with each of the 26 groups:

Drugs of identical chemical composition (so-called generic drugs) formulated and marketed by


Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?




Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


Some tools below are only available to our subscribers or users with an online account.

0 Citations

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.