期刊
JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS
卷 32, 期 4, 页码 387-402出版社
WILEY
DOI: 10.1111/j.1365-2710.2007.00835.x
关键词
bioequivalence; biologicals; botulinum toxin type A; safety margin; Summary of Product Characteristics; therapeutic margin
Background and objective: Because of the unique pharmacology and clinical versatility of botulinum toxin (BoNT), particularly BoNT serotype A (BoNTA), a need exists for discussion of the current data on similarities and differences between two BoNTA products, BOTOX and Dysport. Methods: We compared the physiochemical and pharmacological properties of BOTOX and Dysport using information from the Summary of Product Characteristics (SmPC) documents from a number of countries around the world. Results and discussion: Our analysis based on the SmPC documents demonstrated distinct differences in physical characteristics, breadth of approved indications, dosing and administration, and the incidence and severity of adverse events. Conclusion: BOTOX and Dysport are not bioequivalent. Many of the differences between BOTOX and Dysport discussed within are probably related to the differences in their physical characteristics.
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