Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products
Bibliographic record
Abstract
Although this book will be an invaluable tool for anyone looking to set up a pharmacovigilance reporting program or who needs in-depth information on the regulatory aspects of veterinary adverse reaction reporting, it will not be useful for the general practitioner looking for information on the frequency and types of reported adverse reactions to veterinary vaccines and drugs. The book’s high cost will also make it prohibitive for anyone with less than a devoted interest in veterinary pharmacovigilance. The focus of this book is on the European regulation of veterinary medicinal products and the regulatory aspects of veterinary adverse reaction reporting. While there are 8 separate chapters devoted to veterinary pharmacovigilance regulation in the European Union, the regulation of veterinary pharmacovigilance in Canada, the United States, and Australia are all covered together in one short chapter. However, there are many similarities between the regulatory requirements for adverse reaction reporting in Europe and North America and so general topics can be applied to multiple regions even though the specific regulations governing those regions will be different. Understanding government regulations can sometimes be quite challenging and so one of the major strengths of this book is its tables and figures. Pertinent European regulations and guidelines are clearly listed and several flowcharts illustrate the interrelationships between different groups and how information flows from one area to another and is analyzed. The chapters devoted to industry will be very useful to those companies looking to set up a pharmacovigilance program. Topics covered include: inspections, preclinical safety testing of drugs and vaccines, reaction causality determination, maximum residue limits for livestock, residue surveillance, and withdrawal periods (drugs only as there are no withdrawal periods in Europe for vaccines). One topic that I was happy to see was not forgotten was human reactions to veterinary medicinal products caused by inadvertent exposure to the drugs or vaccines. Two chapters are devoted to these types of reaction. Given the general good quality of the information available in this book, I was very surprised to read about the “anthrax virus” in one place in the book. Such a basic mistake should never have made it into a published veterinary textbook. In summary, I highly recommend this book to anyone working for industry or for a governmental regulatory agency, and who is involved in veterinary adverse reaction reporting.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.046 | 0.027 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".