FDA Issues Guidance on Bioequivalence Studies - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Issues Guidance on Bioequivalence Studies


ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

This month, FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). The guidance is meant to clarify the requirements for the submission of bioequivalence data that were published in 2009 (1). Federal regulations require that all bioequivalence studies performed for a given agent be submitted as part of the ANDA, regardless of whether the study confirms that the product is equivalent to the reference listed drug (RLD).

FDA believes that review of both positive and negative data may be “important in our determination of whether a product is bioequivalent to the RLD and are relevant to our evaluation of generic products in general,” according to the guidance. “These data will increase our understanding of generic drug development and how changes in components and composition may affect formulation performance, as well as promote further development of science-based bioequivalence policies,” says the guidance.

The guidance consists of two sections. The first section clarifies what types of ANDAs must include all bioequivalence studies and specifies the necessary format for a summary report. The second section clarifies what the meaning of “the same product formulation” for immediate-release drug forms, extended-release drug products, semisolid dosage forms, and other complex dosage forms. This section also contains examples of slightly different formulations that would be considered the same product, and of other formulations that would be considered different.

Reference

1. FDA, “Requirements for Submission of Bioequivalence Data; Final Rule.” Fed. Regist. 74(11), 2849–2862 (Jan. 16, 2009).

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
43%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here