scholarly journals Detection of Outlying Subjects in Bioequivalence Trials

2020 ◽  
Vol 35 (1-2) ◽  
Author(s):  
Mohd Harun ◽  
Sumeet Saurav ◽  
Cini Varghese ◽  
Seema Jaggi ◽  
Devendra Kumar
Keyword(s):  
Medicinal Products ◽  
Reference Formulation ◽  
Detection Problem ◽  
Outliers Detection ◽  
Bioequivalence Test ◽  
Veterinary Medicinal Products

Evaluation of veterinary medicinal products is one of the important areas where bioequivalence trials are conducted. One of the problems commonly encountered in bioequivalence trials is outlying subjects. These outlying data may occur either as unexpected observations or as the unusual subject who has extremely high or low bioavailability with respect to the reference formulation and may have dramatic effects on the bioequivalence test. Therefore, it is important to examine the data carefully for identification of outlying observations in bioequivalence studies. In this study we have developed another general approach, termed the Estimated Distance (ED), to the outliers’ detection problem.

scholarly journals The threat of veterinary medicinal products and biocides on pollinators: A One Health perspective

One Health ◽  
2021 ◽  
pp. 100237
Author(s):  
K.L. Mahefarisoa ◽  
N. Simon Delso ◽  
V. Zaninotto ◽  
M.E. Colin ◽  
J.M. Bonmatin
Keyword(s):  
One Health ◽  
Medicinal Products ◽  
Veterinary Medicinal Products

scholarly journals Dead in the water: comment on “Development of an aquatic exposure assessment model for imidacloprid in sewage treatment plant discharges arising from use of veterinary medicinal products”

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Rosemary Perkins ◽  
Martin Whitehead ◽  
Dave Goulson
Keyword(s):  
Sewage Treatment ◽  
Sewage Treatment Plant ◽  
Treatment Plant ◽  
Assessment Model ◽  
Implicit Assumption ◽  
Small Contribution ◽  
Medicinal Products ◽  
Ecotoxicological Thresholds ◽  
The Uk ◽  
Veterinary Medicinal Products

AbstractAnthe et al. (Environ Sci Eur 32:147, 2020. 10.1186/s12302-020-00424-4) develop a mathematical model to calculate the contribution of veterinary medicinal products (VMPs) to the levels of imidacloprid observed in the UK water monitoring programme. They find that VMPs make only a very small contribution to measured pollution levels, and that the estimated concentrations do not exceed ecotoxicological thresholds. However, shortcomings in methodology—including the implicit assumption that imidacloprid applied to pets is available for release to the environment for 24 h only and failure to incorporate site-specific sewage effluent data relating to measured levels—raise questions about their conclusions. Adjusting for these and other deficiencies, we find that their model appears consistent with the conclusion that emissions from VMPs may greatly exceed ecotoxicological thresholds and contribute substantially to imidacloprid waterway pollution in the UK. However, the model utilises imidacloprid emissions fractions for animals undergoing the different scenarios (for example, bathing) that are extrapolated from unpublished studies that do not clearly resemble the modelled scenarios, with insufficient evidence provided to support their derivation. As a result, we find that the model presented by Anthe et al. provides no reliable conclusions about the contribution of veterinary medicinal products to the levels of imidacloprid in UK waterways.

scholarly journals Reforming of legislation on the residues of veterinary medicinal products in foodstuffs of animal origin as a component of Ukraine food security

2020 ◽  
Vol 22 (100) ◽  
pp. 108-115
Author(s):  
I. Berezovska
Keyword(s):  
Food Security ◽  
Legal Regulation ◽  
Economic Security ◽  
Animal Origin ◽  
The European Union ◽  
Medicinal Products ◽  
Association Agreement ◽  
National Legislation ◽  
The Eu ◽  
Veterinary Medicinal Products

It is known that the food security of the state, aimed at providing the population with quality and healthy food, is an important component of economic security. Recent developments in the world and national security challenges posed by the Covid-19 virus pandemic necessitate a reassessment of approaches to the legal regulation of issues that significantly affect human health. Today, the reform of the relevant national legislation on FAR residues in food requires a systematic and holistic approach and the definition of its priorities in such a way as to promote food safety and the development of domestic business. The article is devoted to the analysis of the current Ukraine legislation concerning regulation of residues of veterinary medicinal products in foodstuffs of animal origin. It was shown that the formation of such legislation was due to the development of international trade, including the fulfilment of the European Union requirements for the safety of foodstuffs imported into its market. At the same time, the conclusion of the Association Agreement and the introduction of a Free trade zone with the EU was a significant impetus to the reforming of national legislation on residues. The analysis of EU regulations, which serves as a legal basis for the residues control at the EU level, was carried out. It is noted that today in the Ukrainian legislation, despite the introduction of annual national plans for state monitoring of residues of veterinary medicinal products and contaminants in live animals and unprocessed foodstuffs of animal origin, there are a number of gaps that require urgent legislative regulation. It was proved that the completion of the reform of the national legislation on residues will contribute to improving safety of domestic foodstuffs, and therefore, will have important positive consequences not only for the development of trade with the EU, but primarily for the food security of Ukraine and the protection of the health of Ukrainian citizens.

Growth promoters: reassessing the risk

1991 ◽  
Vol 1991 ◽  
pp. 43-43
Author(s):  
A.R. Peters
Keyword(s):  
Antimicrobial Activity ◽  
Feed Additives ◽  
Growth Promoter ◽  
Therapeutic Action ◽  
Medicinal Products ◽  
Growth Promoters ◽  
Consumer Concerns ◽  
Binding Agents ◽  
Veterinary Medicinal Products

Legislation to control veterinary medicinal products is undergoing continual development in the EEC and UK and therefore the risks are continually reassessed. In the present paper current and future legislation together with consumer concerns both real and imaginary are reviewed.Since the EEC ban on hormonal growth promoter implants in 1986 the remaining legal products are all feed additives. Registration of feed additives in the EEC is controlled under Directive 70/524 and its various amending directives. this directive is concerned with all products added to feed and mainly includes substances used to affect the quality of the feedstuff i.e., emulsifiers, stabilisers, antioxidants, colorants and binding agents and also vitamins and micronutrients. The majority of growth promoters exert their affects by antimicrobial activity and these and certain prophylactic medicinal products such as coccidiostats are also included. All products with a therapeutic action are controlled under the Veterinary Medicine Directives 81/851 and 81/852, quite separate legislation and under the responsibility of a different department within the EEC Coimdssion. However, there is provision under Directive 84/587 amending 70/524 to transfer the medicinal feed additives to 81/851 and 81/852.

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