The Current Scientific and Legal Status of Alternative Methods to the LD50 Test for Botulinum Neurotoxin Potency Testing

Author:

Adler Sarah1,Bicker Gerd2,Bigalke Hans3,Bishop Christopher4,Blümel Jörg5,Dressler Dirk6,Fitzgerald Joan7,Gessler Frank8,Heuschen Heide9,Kegel Birgit10,Luch Andreas111,Milne Catherine12,Pickett Andrew13,Ratsch Heidemarie14,Ruhdel Irmela15,Sesardic Dorothea16,Stephens Martin17,Stiens Gerhard18,Thornton Peter D.19,Thürmer René9,Vey Martin5,Spielmann Horst120,Grune Barbara1,Liebsch Manfred1

Affiliation:

1. Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET), Federal Institute for Risk Assessment (BfR), Berlin, Germany

2. University of Veterinary Medicine Hannover, Division of Cell Biology, Hannover, Germany

3. Institute of Toxicology, Medical School of Hannover, Hannover, Germany

4. Wickham Laboratories, Wickham, Hampshire, UK

5. Merz Pharmaceuticals GmbH, Frankfurt (Main), Germany

6. Department of Neurology, Rostock University, Germany

7. Allergan, Inc., Irvine, CA, USA

8. Institute for Applied Biotechnology in the Tropics at the University of Göttingen, Göttingen, Germany

9. Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany

10. Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany

11. Department of Product Safety, Federal Institute for Risk Assessment, Berlin, Germany

12. European Directorate of the Quality of Medicines and Health Care (EDQM), Strasbourg, France

13. Ipsen Biopharm Limited, Wrexham, UK

14. Landesamt für Gesundheit und Soziales Berlin (LAGeSo), Berlin, Germany

15. Akademie für Tierschutz, Neubiberg, Germany

16. National Institute for Biological Standards and Control (NIBSC), Health Protection Agency (HPA), Potters Bar, Hertfordshire, UK

17. The Humane Society of the United States (HSUS), Washington, USA

18. Federal Ministry of Food, Agriculture and Consumer Protection (BMELV), Bonn, Germany

19. Home Office, ASPI, London, UK

20. Free University Berlin, Berlin, Germany

Publisher

SAGE Publications

Subject

Medical Laboratory Technology,Toxicology,General Biochemistry, Genetics and Molecular Biology,General Medicine

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