The Experts below are selected from a list of 171 Experts worldwide ranked by ideXlab platform
D.m. Gatewood - One of the best experts on this subject based on the ideXlab platform.
-
Rabies vaccine standards: Comparison of the 5th and 6th WHO international reference standards to the USDA Veterinary reference standard
Vaccine, 2012Co-Authors: J.r. Hermann, A.m. Fry, M.m. Reising, P. Patterson, D. Siev, D.m. GatewoodAbstract:Ensuring rabies vaccines are potent and effective is paramount in preventing transmission of this deadly disease and safeguarding public health. Efficacy of human and Veterinary vaccines is ensured by evaluating relative potency estimates of the vaccine compared to a rabies reference standard using the National Institutes of Health (NIH) test. Reference vaccines are based on the International Standard for Rabies Vaccine provided by the World Health Organization (WHO). A comparison study was conducted to determine the relative potency of the 5th WHO, 6th WHO, and United States Department of Agriculture's (USDA) 08-14 reference standards using the NIH test. Results from the study demonstrate that the 6th WHO reference standard is approximately twice as potent as the 5th WHO reference when reconstituted to contain 1 IU per ml. Based on these results, the Center for Veterinary Biologics (CVB) doubled the reconstitution volume of USDA Veterinary reference 08-14 from 13 ml to 26 ml, for an initial use dilution of 0.7 IU per ml for use by Veterinary Biologics manufacturers in the NIH test. This study emphasizes the importance of reference standard calibration for use in the National Institutes of Health test.
J.r. Hermann - One of the best experts on this subject based on the ideXlab platform.
-
Rabies vaccine standards: Comparison of the 5th and 6th WHO international reference standards to the USDA Veterinary reference standard
Vaccine, 2012Co-Authors: J.r. Hermann, A.m. Fry, M.m. Reising, P. Patterson, D. Siev, D.m. GatewoodAbstract:Ensuring rabies vaccines are potent and effective is paramount in preventing transmission of this deadly disease and safeguarding public health. Efficacy of human and Veterinary vaccines is ensured by evaluating relative potency estimates of the vaccine compared to a rabies reference standard using the National Institutes of Health (NIH) test. Reference vaccines are based on the International Standard for Rabies Vaccine provided by the World Health Organization (WHO). A comparison study was conducted to determine the relative potency of the 5th WHO, 6th WHO, and United States Department of Agriculture's (USDA) 08-14 reference standards using the NIH test. Results from the study demonstrate that the 6th WHO reference standard is approximately twice as potent as the 5th WHO reference when reconstituted to contain 1 IU per ml. Based on these results, the Center for Veterinary Biologics (CVB) doubled the reconstitution volume of USDA Veterinary reference 08-14 from 13 ml to 26 ml, for an initial use dilution of 0.7 IU per ml for use by Veterinary Biologics manufacturers in the NIH test. This study emphasizes the importance of reference standard calibration for use in the National Institutes of Health test.
Richard Hill - One of the best experts on this subject based on the ideXlab platform.
-
Translating Research into Licensed Vaccines and Validated and Licensed Diagnostic Tests
Developments in biologicals, 2013Co-Authors: Richard Hill, N. E. Clough, P.l. Foley, L.r. Ludemann, D.c. MurtleAbstract:The USDA Center for Veterinary Biologics (CVB) has the regulatory authority to issue licenses and permits that allow the marketing of pure, safe, potent, and effective Veterinary biological products. Under the standard licensing or permitting process, a manufacturer develops, characterizes, and evaluates a product prior to licensure. The CVB evaluates the submitted information, inspects the manufacturing facilities and methods of production and testing, and confirms key product test results through independent testing. This complete and comprehensive evaluation may not be possible during the emergence of a new animal disease or in response to an introduction of a significant transboundary animal disease agent. Processes are in place in the US that allow for more rapid availability of Veterinary products in an emerging or emergency animal health situation. But, it can be advantageous to attain preapproval of products prior to their anticipated need. In this article, issues associated with obtaining approval for use of a biological product under emerging or emergency conditions are discussed.
-
Alternative Methods to Reduce, Refine, and Replace the Use of Animals In the Development and Testing of Veterinary Biologics in The United States; a Strategic Priority.
Procedia in vaccinology, 2011Co-Authors: Richard HillAbstract:The Virus-Serum-Toxin Act of 1913 provides the legal basis for the regulation of Veterinary biological products in the United States, and the USDA's Center for Veterinary Biologics (CVB) has the authority to issue licenses and permits for such products. The law was intended to establish standards and control the importation of products into the United States as well as the domestic distribution of products, assuring the purity, safety, potency, and efficacy of Veterinary biological products. Prelicensing data evaluation procedures are designed to assess the quality of each product and support product label claims. Under the standard licensing process, this spectrum of evaluation includes complete characterization of seed material and ingredients, and laboratory- and host-animal safety and efficacy studies. Post-license testing includes batch tests for purity, safety, and potency. As part of the production and testing of regulated products, procedures involving animals are used to validate product requirements for safety, potency, and efficacy. Incorporating alternative methods to reduce, refine, and replace the use of animals in the development and testing of Veterinary biological products has been a strategic goal for the CVB for several decades, and current licensing processes and policies are designed to support and encourage the shift from animal-based methods to alternative practices while ensuring that regulated products continue to be safe and effective.
-
Regulatory issues with new and unlicensed Veterinary biological products
Biopharm International, 2004Co-Authors: Patricia L. Foley, Richard HillAbstract:Bringing Veterinary Biologics to full licensure can be a long process - too long if a new animal disease emerges or a foreign disease enters the US. The authors describe six mechanisms to bring a product into use more quickly and also discuss licensing challenges for innovative biological products.
-
Regulation of conditionally licensed biologicals in the United States.
Developments in biologicals, 2004Co-Authors: Richard HillAbstract:The Virus-Serum-Toxin Act of 1913 (21 US Code 151-159) provides the legal basis for the regulation of Veterinary biologicals in the United States and the United States Department of Agriculture's Center for Veterinary Biologics (CVB) has the regulatory authority for the issuing of licences and permits for such products. The law was intended to establish standards and control the importation of products into the United States and the distribution of products interstate assuring the purity, safety, potency, and efficacy of Veterinary biological products. Under certain specific circumstances, product licences may be issued in the United States under expedited procedures which assure purity, safety, and a "reasonable expectation" of efficacy. These conditional licences may be authorized to meet an emergency condition, limited market, local situation, or other special circumstances, and provide valuable tools for veterinarians and consumers in improving animal health.
L.a. Wilbur - One of the best experts on this subject based on the ideXlab platform.
-
Statistical methods for analysis of in vitro antigen quantification data for Veterinary biologic products.
Veterinary microbiology, 1993Co-Authors: L.a. WilburAbstract:Abstract In vitro assay systems that measure the antigen content of Veterinary biologic products use a statistical model for quantification. The most prevalent assay system for measuring Veterinary Biologics in the United States compares a reference, demonstrated to be protective in the host species, to the serial being tested. An ideal statistical model evaluates the similarity of response and compares the amount of antigen of a serial to the reference. This method is defined as the relative potency approach. Various statistical methods have been proposed for relative potency determinations. The standard curve, slope ratio assay, parallel line assay, four-parameter (logistics) fit, and intergration of the area under the curve have been used. Each statistical method has strenghts and weaknesses. The parallel line assay accepts data from assays with non-ideal dose response curves, provides a similarity comparison, and evaluates the relatice potency in the most linear portion of the curve. The parallel line method is recommended for evaluation of in vitro assays for potency determination of U.S. licensed Veterinary Biologics.
A.m. Fry - One of the best experts on this subject based on the ideXlab platform.
-
Rabies vaccine standards: Comparison of the 5th and 6th WHO international reference standards to the USDA Veterinary reference standard
Vaccine, 2012Co-Authors: J.r. Hermann, A.m. Fry, M.m. Reising, P. Patterson, D. Siev, D.m. GatewoodAbstract:Ensuring rabies vaccines are potent and effective is paramount in preventing transmission of this deadly disease and safeguarding public health. Efficacy of human and Veterinary vaccines is ensured by evaluating relative potency estimates of the vaccine compared to a rabies reference standard using the National Institutes of Health (NIH) test. Reference vaccines are based on the International Standard for Rabies Vaccine provided by the World Health Organization (WHO). A comparison study was conducted to determine the relative potency of the 5th WHO, 6th WHO, and United States Department of Agriculture's (USDA) 08-14 reference standards using the NIH test. Results from the study demonstrate that the 6th WHO reference standard is approximately twice as potent as the 5th WHO reference when reconstituted to contain 1 IU per ml. Based on these results, the Center for Veterinary Biologics (CVB) doubled the reconstitution volume of USDA Veterinary reference 08-14 from 13 ml to 26 ml, for an initial use dilution of 0.7 IU per ml for use by Veterinary Biologics manufacturers in the NIH test. This study emphasizes the importance of reference standard calibration for use in the National Institutes of Health test.
