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Botulinum Neurotoxin Potency Testing
Medicinal products containing Botulinum Neurotoxin (BoNT) are used for treating a variety of medical disorders, such as e.g. blepharospasm or strabismus. BoNT products are also used in so-called "aesthetic medicine" to temporarily reduce facial lines. Each BoNT product is assayed using the mouse LD50 potency test as regulatory required. The end-point of the assay is based on measuring lethality rates in mice.
In 2009 the international Expert Working Group (BoNT EWG) was established at the BfR. The objective of the BoNT EWG is to provide advice and guidance on validation and implementation of alternative methods in BoNT potency testing. ZEBET in collaboration with the Federal Institute for Drugs and Medical Devices (BfArM) takes the chair of the BoNT EWG.
Scope and Objectives of the BoNT EWG 
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Terms of Reference of the BoNT EWG (38.3 KB)
Report and Recommendations of the public ZEBET Expert Meeting in April 2009 (376.1 KB)
BfR Press release "Fewer animals for the testing of botox medicinal products!"
Current developments towards in vitro potency testing of BoNT medicinial products
other
(3 documents)Press information
(1 document)| Date | Title | Keywords |
|---|---|---|
|
06.05.2009 07/2009 |
Fewer animals for the testing of botox medicinal products! |
