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Related Experiment Video

Updated: May 7, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Confidence in generic drug substitution.

R Lionberger¹, W Jiang, S-M Huang

¹Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA.

Clinical Pharmacology and Therapeutics

|September 20, 2013

Summary

Patients can trust generic drugs in the US. The Food and Drug Administration (FDA) uses new study designs and post-approval monitoring to ensure generic drugs are safely substitutable for brand-name medications.

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Last Updated: May 7, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump

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Published on: March 11, 2017

Area of Science:

Pharmaceutical Sciences
Regulatory Science
Drug Efficacy

Background:

Ensuring patient confidence in generic drug substitution is crucial for medication adherence and public health.
Generic drugs must demonstrate bioequivalence to their brand-name counterparts for safe and effective use.
Regulatory oversight is essential to maintain the quality and interchangeability of pharmaceutical products.

Purpose of the Study:

To assure patients that generic drugs are therapeutically equivalent to brand-name drugs in the United States.
To outline the US Food and Drug Administration's (FDA) strategies for ensuring generic drug substitution.
To address the specific challenges of generic substitution for narrow therapeutic index (NTI) drugs.

Main Methods:

Implementing novel bioequivalence study designs tailored for narrow therapeutic index (NTI) drugs.
Conducting post-approval studies to monitor the real-world performance of generic drug substitutions.
Leveraging ongoing regulatory science initiatives by the FDA.

Main Results:

New bioequivalence study designs are being developed for NTI drugs.
Post-approval studies will provide data on the success of generic substitutions.
FDA's regulatory science activities aim to guarantee generic substitution for all drug products.

Conclusions:

The FDA's comprehensive approach enhances confidence in generic drug substitution.
Advanced study designs and post-approval monitoring ensure the safety and efficacy of generic medications.
These efforts support the availability of high-quality generic drugs for all patients.