Use of probabilistic modeling within a physiologically based pharmacokinetic model to predict sulfamethazine residue withdrawal times in edible tissues in swine.
(9/18)
The presence of antimicrobial agents in edible tissues of food-producing animals remains a major public health concern. Probabilistic modeling techniques incorporated into a physiologically based pharmacokinetic (PBPK) model were used to predict the amounts of sulfamethazine residues in edible tissues in swine. A PBPK model for sulfamethazine in swine was adapted to include an oral dosing route. The distributions for sensitive parameters were determined and were used in a Monte Carlo analysis to predict tissue residue times. Validation of the distributions was done by comparison of the results of a Monte Carlo analysis to those obtained with an external data set from the literature and an in vivo pilot study. The model was used to predict the upper limit of the 95% confidence interval of the 99th percentile of the population, as recommended by the U.S. Food and Drug Administration (FDA). The external data set was used to calculate the withdrawal time by using the tolerance limit algorithm designed by FDA. The withdrawal times obtained by both methods were compared to the labeled withdrawal time for the same dose. The Monte Carlo method predicted a withdrawal time of 21 days, based on the amounts of residues in the kidneys. The tolerance limit method applied to the time-limited data set predicted a withdrawal time of 12 days. The existing FDA label withdrawal time is 15 days. PBPK models can incorporate probabilistic modeling techniques that make them useful for prediction of tissue residue times. These models can be used to calculate the parameters required by FDA and explore those conditions where the established withdrawal time may not be sufficient. (+info)
Occupational zoonoses in animal husbandry and related activities.
(10/18)
The fact that people working with animals or their products may contract some infections has been known for centuries, before the introduction of the concept of zoonoses. Only recently, at least in Italy, was the prevention of occupational risks taken into account by legislation in spite of the fact that some zoonoses of livestock are of noticeable socio-economic importance. Nowadays some factors such as new production technologies, trade globalization, movements of people, changes in working conditions, are generating new zoonotic and occupational risks, some of which are considered re-emerging. The prevention of occupational zoonoses must be implemented jointly by both veterinary and medical services through prevention and epidemiological surveillance of human and animal health, risk evaluation, diagnosis of infections and working safety. Hopefully, we expect that in the future there will be better interdisciplinary collaboration and that legislation be timely tailored to the need to safeguard working health and safety. (+info)
An overview of patent law as applied to the field of veterinary medicine.
(11/18)
Using foresight to prepare animal health today for tomorrow's challenges.
(13/18)
Foresight has been introduced in Canada in the area of animal health as a process to broaden thinking about the future and inform policy development. Its initial use and evolution through projects and studies over the past decade are described, demonstrating real action in animal health. Despite positive, continuing, and exciting results in animal health policy development, foresight's widespread acceptance and use thus far have been limited. Critical components for success, drawn from the Canadian experience, are described, and recommendations are offered for further action in animal health. (+info)
Salmonella in pigs and animal feeding stuffs in England and Wales and in Denmark.
(14/18)
A comparison has been made between the incidence of salmonellas in pigs and feeding stuffs in England and Wales and in Denmark. In Denmark there is veterinary legislation requiring the sterilization of imported and home produced feed ingredients of animal origin. There is no such legislation in England and Wales. In Denmark 0.3% of resterilized imported meat and bone meal was contaminated with salmonellas. This compared with 23% of meat and bone meal in England and Wales and 20-27% of other ingredients of animal origin. In England and Wales salmonellas were isolated from 7% of caecal samples and 6% of lymph node samples, while in Denmark they were isolated from 3% of caecal samples and 4% of lymph node samples. In England and Wales 25 serotypes were found in both pigs and feeds and these included nearly all the most prevalent human pathogens. In Denmark four of the six serotypes in pigs had been found in resterilized feed. One notable difference between the two studies was the very wide range of serotypes found in pigs in England and Wales and the narrow range in Denmark. A second was that Salmonella typhimurium formed 15% of all Salmonella strains isolated from pigs in England and Wales, and 60% of those in Denmark.It is concluded that sterilization of animal raw ingredients in Denmark has reduced pig infections with types other than S. typhimurium that are found in England and Wales, but not with S. typhimurium. It is possible that this is because S. typhimurium once introduced into pigs is able to establish itself more easily than other serotypes. (+info)
Misuse of drugs act 1971.
(15/18)
An attempt is made to explain the provisions of the Misuse of Drugs Act 1971 stressing, where possible, those portions of the Act which affect members of the medical profession. (+info)
Regulation of animal care and research. The final order on Good Laboratory Practices.
(16/18)
On June 20, 1979, the Food and Drug Administration (FDA) enacted all aspects of its Good Laboratory Practices (GLP) program. The program was instituted to ensure the quality and integrity of the safety data submitted to FDA in support of the approval of regulated products, including human and animal drugs, food additives, biologicals, radiation-emitting products and human medical devices. Moreover, these considerations include all safety data submitted to support applications for research and marketing permits. These steps were taken in response to the appalling circumstances uncovered in a limited series of inspections of laboratories that was performed during 1975. FDA found careless experimentation, improperly trained employees, unreviewed data, omitted data, improper laboratory and animal care procedures and improperly monitored contract studies, including the failure of sponsors to validate the data appearing in the final study reports. The Congress responded to this situation by allocating FDA 600 new positions and .$16 million to remedy the problems that were evident. In their final form, the GLP's represent regulations fine tuned to assure proper safety testing with a minimum of increased cost. It is hoped that these regulations will increase public confidence in FDA decision making and will help to ensure that safe products are approved for marketing. (+info)