Bioequivalence

Introduction

Bioequivalence (BE) is a critical aspect of ensuring the quality and efficacy of generic drugs. The National Agency for Food and Drug Administration and Control (NAFDAC) is committed to providing a framework for the evaluation and approval of bioequivalent products. This page serves as a resource for stakeholders, including pharmaceutical companies, researchers, and regulatory professionals, to access information on bioequivalence guidelines, regulations, and best practices.

What is Bioequivalence?

Bioequivalence is the absence of a significant difference in the rate and extent of absorption of an active ingredient from two or more formulations. This concept is essential in ensuring that generic drugs are as effective and safe as their reference products.

NAFDAC’s Bioequivalence Guidelines

NAFDAC has established guidelines for bioequivalence studies to ensure that generic drugs meet the required standards. These guidelines are based on international best practices and are designed to ensure that bioequivalence studies are conducted in a manner that is consistent with global regulatory expectations.

Relevant Links

NAFDAC Bioequivalence Guidelines

Bioequivalence Study Requirements

NAFDAC requires that bioequivalence studies be conducted in accordance with international standards and best practices. The following are some of the key requirements for bioequivalence studies:

• Study Design: Bioequivalence studies must be designed to demonstrate the absence of a significant difference in the rate and extent of absorption of the active ingredient.
• Study Population: The study population must be representative of the target population.
• Sampling and Analysis: Sampling and analysis must be conducted in accordance with established protocols.

Frequently Asked Questions (FAQs)

• What is the purpose of bioequivalence studies?: Bioequivalence studies are conducted to demonstrate that a generic drug is as effective and safe as its reference product.
• How are bioequivalence studies designed?: Bioequivalence studies are designed to demonstrate the absence of a significant difference in the rate and extent of absorption of the active ingredient.

Contact Us

For more information on bioequivalence guidelines, regulations, and best practices, please contact NAFDAC’s Regulatory Affairs Department.