Test Method Nomination to the ICCVAM Nomination of Alternative Methods to Replace the Mouse LD50 Assay for Botulinum Toxin Potency Testing
نویسنده
چکیده
منابع مشابه
Alternatives to the LD50 assay for botulinum toxin potency testing: Strategies and progress towards refinement, reduction and replacement
Therapeutic preparations of botulinum toxin products are calibrated by a mouse LD50 assay, and the labelled unit of activity is expressed in mouse LD50 units, defined as the median lethal intraperitoneal dose at a defined time-point. Potency and stability testing are required at several stages of the production process. Testing at the final lot stage requires high precision, so a large number o...
متن کاملNomination of the National Toxicology Program Rodent Bioassay for ICCVAM Review and Validation This nomination is made in accordance with Public Law 106–545 SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION OF ALTERNATIVE
SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION OF ALTERNATIVE METHODS. (b) PURPOSES.—The purposes of the ICCVAM shall be to— (1) increase the efficiency and effectiveness of Federal agency test method review; (2) eliminate unnecessary duplicative efforts and share experiences between Federal regulatory agencies; and (e) DUTIES.—The ICCVAM shall, consistent with the purposes descri...
متن کاملNomination of the National Toxicology Program Rodent Bioassay for ICCVAM Review and Validation This nomination is made in accordance with Public Law 106–545 SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION OF ALTERNATIVE
SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION OF ALTERNATIVE METHODS. (b) PURPOSES.—The purposes of the ICCVAM shall be to— (1) increase the efficiency and effectiveness of Federal agency test method review; (2) eliminate unnecessary duplicative efforts and share experiences between Federal regulatory agencies; and (e) DUTIES.—The ICCVAM shall, consistent with the purposes descri...
متن کاملNomination to ICCVAM: BoTestTM Botulinum Neurotoxin Detection Kits
Preamble: BioSentinel is submitting nominations for three different product typesthe BoTestTM BoNT Detection Kits, the BoTestTM Matrix BoNT Detection Kits, and the BoCellTM A Cell-based assay. These products differ in their BoNT sensitivity and tolerance to complex matrices. While an independent evaluation of each assay is required, these products should be considered a suite of solutions for d...
متن کاملThe Current Scientific and Legal Status of Alternative Methods to the LD50 Test for Botulinum Neurotoxin Potency Testing
An Expert Meeting on The Current Scientific and Legal Status of Alternative Methods to the LD50 Test for Botulinum Neurotoxin (BoNT) Potency Testing was organised by the Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET) at the Federal Institute for Risk Assessment (BfR), and took place on 27–28 April 2009, in Berlin, Germany. The goal of ZEBET is to promote p...
متن کامل