Animal & Veterinary
Office of New Animal Drug Evaluation (ONADE): Upcoming Bioequivalence Workshop
By Dr. Marilyn Martinez, ONADE, with Contributions by Dr. Melanie Mclean, Senior Writer/Editor, Communications
Several members of CVM’s Office of New Animal Drug Evaluation (ONADE) will be presenting and chairing sessions at an upcoming workshop on bioequivalence issues in veterinary medicine. The workshop, sponsored by the American Academy of Veterinary Pharmacology and Therapeutics (AAVPT), will be held in Potomac, MD, from June 27 to 30, 2010.
The term “bioequivalence” reflects the pharmacological similarity of different drugs or different formulations of the same drug. Two drugs, or two formulations of the same drug, are “bioequivalent” if they are given at the same dose, contain the same active ingredient, and reach the same levels at the site of action.
The idea that bioequivalence is important in FDA’s drug review process goes back to the early 1970s, when the National Academy of Science held a bioequivalence symposium. Today, both CVM and the Center for Drug Evaluation and Research (CDER, the FDA Center that reviews drugs for people) have guidelines describing how FDA evaluates bioequivalence for animal and human drugs.
CVM looks at bioequivalence when reviewing generic animal drugs, which are copies of approved brand name animal drugs. CVM also looks at bioequivalence when a drug sponsor wants to change the formulation of an approved animal drug.
There are many situations where traditional approaches to assessing product bioequivalence may not be appropriate, such as for drugs that:
- Have highly variable absorption characteristics;
- Slowly release the active ingredient over months or years;
- Are given directly into an animal’s udder;
- Are given in feed; or
- Do not go through the bloodstream before reaching the site of action.
A review article that discusses many of these complex situations, co-authored by Drs. Marilyn Martinez (ONADE/CVM/FDA) and Robert Hunter (Elanco Animal Health), will appear in an upcoming issue of the Journal of Veterinary Pharmacology and Therapeutics.
The AAVPT Bioequivalence Workshop includes three days of discussion on new ways to evaluate bioequivalence in challenging cases. Before the workshop, AAVPT will be hosting a 2½ hour webinar to discuss the basics of how CVM traditionally evaluates bioequivalence. Also, following the workshop, task groups will be formed to write “White Papers” that present the best and most current scientific thinking on more than 12 complex bioequivalence issues.
For more information about the workshop or webinar or about how to be on a White Paper task force, please visit the following Web site: http://www.aavpt.org/BE_workshop.shtml.