scholarly journals Principles for Assessing Adversity in Toxicologic Clinical Pathology

2017 ◽  
Vol 45 (2) ◽  
pp. 260-266 ◽  
Author(s):  
Lila Ramaiah ◽  
Lindsay Tomlinson ◽  
Niraj K. Tripathi ◽  
Laura C. Cregar ◽  
Allison Vitsky ◽  
...  
Keyword(s):  
Clinical Pathology ◽  
Integrated Approach ◽  
Data Interpretation ◽  
Weight Of Evidence ◽  
Regulatory Guidance ◽  
Regulatory Affairs ◽  
Safety Studies ◽  
American Society ◽  
The Impact

There is limited direction in the literature or regulatory guidance on determination of adversity for clinical pathology (CP) biomarkers in preclinical safety studies. Toxicologic clinical pathologists representing the American Society for Veterinary Clinical Pathology—Regulatory Affairs Committee and Society of Toxicologic Pathology—Clinical Pathology Interest Group identified principles, overall approach, and unique considerations for assessing adversity in CP data interpretation to provide a consensus opinion. Emphasized is the need for pathophysiologic context and a weight-of-evidence approach. Most CP biomarkers do not have the potential to be adverse in isolation, regardless of magnitude of change. Rather, they quantify or describe the impact of effects, provide adjunct or supportive information regarding a process or pathogenesis, and provide translational biomarkers of effect. Most often, CP changes are part of a constellation of findings that collectively are adverse. Thus, most CP changes must be interpreted in conjunction with other study findings and require contextual and integrative interpretation. Exceptions include critical CP changes without correlates that indicate a health risk in the tested species. Overall, CP changes should not be interpreted in isolation and their adversity is best addressed with an integrated approach.

Clinical Pathology Testing Recommendations for Nonclinical Toxicity and Safety Studies

1992 ◽  
Vol 20 (3-2) ◽  
pp. 539-543 ◽  
Author(s):  
Kurt Weingand ◽  
John Bloom ◽  
Michael Carakostas ◽  
Robert Hall ◽  
Maria Helfrich ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Clinical Pathology ◽  
Regulatory Agencies ◽  
Blood Collection ◽  
Safety Studies ◽  
Safety Assessments ◽  
American Society ◽  
Clinical Laboratory Testing ◽  
Technical Recommendations

Clinical pathology testing in nonclinical toxicity and safety studies is an important part of safety assessment. In recent years, clinical laboratory testing has rapidly expanded and improved. Some government regulatory agencies provide guidelines for clinical pathology testing in nonclinical toxicity and safety studies. To improve these testing guidelines and the resultant safety assessments, the American Association for Clinical Chemistry's Division of Animal Clinical Chemistry and the American Society for Veterinary Clinical Pathology formed a joint committee to provide expert recommendations for clinical pathology testing of laboratory species involved in subchronic and chronic nonclinical toxicity and safety studies. These recommendations include technical recommendations on blood collection techniques and hematology, serum chemistry, and urinalysis tests.

scholarly journals STP Best Practices for Evaluating Clinical Pathology in Pharmaceutical Recovery Studies

2016 ◽  
Vol 44 (2) ◽  
pp. 163-172 ◽  
Author(s):  
Lindsay Tomlinson ◽  
Lila Ramaiah ◽  
Niraj K. Tripathi ◽  
Valerie G. Barlow ◽  
Allison Vitsky ◽  
...  
Keyword(s):  
Best Practices ◽  
Vaccine Development ◽  
Clinical Pathology ◽  
Data Interpretation ◽  
Recovery Phase ◽  
Development Programs ◽  
Toxicity Studies ◽  
Delayed Toxicity ◽  
American Society ◽  
Pathology Data

The Society of Toxicologic Pathology formed a working group in collaboration with the American Society for Veterinary Clinical Pathology to provide recommendations for the appropriate inclusion of clinical pathology evaluation in recovery arms of nonclinical toxicity studies but not on when to perform recovery studies. Evaluation of the recovery of clinical pathology findings is not required routinely but provides useful information on risk assessment in nonclinical toxicity studies and is recommended when the ability of the organ to recover is uncertain. The study design generally requires inclusion of concurrent controls to separate procedure-related changes from test article–related changes, but return of clinical pathology values toward baseline may be sufficient in some cases. Evaluation of either a select or full panel of standard hematology, coagulation, and serum and urine chemistry biomarkers can be scientifically justified. It is also acceptable to redesignate dosing phase animals to the recovery phase or vice versa to optimize data interpretation. Assessment of delayed toxicity during the recovery phase is not required but may be appropriate in development programs with unique concerns. Evaluation of the recovery of clinical pathology data for vaccine development is required and, for efficacy markers, is recommended if it furthers pharmacologic understanding.

scholarly journals Haematological reference intervals of sows at end gestation in ten French herds, the impact of parity on haematological parameters and the consequences on reproductive performance

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Gwenaël Boulbria ◽  
Charlotte Teixeira Costa ◽  
Valérie Normand ◽  
Véronique Bachy ◽  
Daphné Rochel ◽  
...  
Keyword(s):  
Reproductive Performance ◽  
White Blood Cells ◽  
Clinical Pathology ◽  
Reference Intervals ◽  
Production Performance ◽  
Haematological Parameters ◽  
Haematological Parameter ◽  
Haematological Values ◽  
American Society ◽  
The Impact

Abstract Background Changes in haematological values occur during the reproductive cycle. In veterinary swine practice, haematological reference intervals for this period are scarce. Over past decades, there has been a remarkable increase in reproductive prolificacy, possibly making previously established haematological reference intervals for sows outdated. Objectives The aim of this study was to provide updated haematological reference intervals for sows at end-gestation, to study the influence of parity on those haematological parameters and to evaluate the impact of haemoglobin levels on production performance. Methods The data presented in this article were obtained using blood samples from 198 apparently healthy and conventionally managed group-housed sows at end-gestation from ten breeding herds located in France. The samples were analysed for haematological variables using impedance technique on Horiba ABX analyser (Horiba, Kyoto, Japan). The reference intervals were calculated according to the guidelines of The American Society for Veterinary Clinical Pathology using SUMMARY procedure in R Studio. Analysis of variance (ANOVA) models were used to evaluate the influence of parity on each haematological parameter and the impact of haemoglobin values on production performances at farrowing. Differences were considered as significant if p < 0.05. Results Reference intervals produced in this study were similar to previously published references but we noticed marked differences in white blood cell values. The study of the impact of parity revealed significant changes for gilts and parity 5 + sows regarding haematological values. Gilts had higher red and white blood cells counts, haemoglobin values and haematocrit values. Regarding haemoglobin values, the higher the number of liveborn and weaned piglets per litter, the lower the haemoglobin value at end-gestation. For sows of fifth or higher gestation, we found that the higher the percentage of stillborn piglets, the lower the haemoglobin value at end-gestation. Conclusions This study provides haematological reference intervals for sows at end-gestation. These will be useful for swine veterinarians and researchers for a better understanding of the influence of parity on haematological parameters and haemoglobin values and their relation to reproductive performance.

scholarly journals Recommendations for Clinical Pathology Data Generation, Interpretation, and Reporting in Target Animal Safety Studies for Veterinary Drug Development

2017 ◽  
Vol 36 (4) ◽  
pp. 293-302 ◽  
Author(s):  
William Siska ◽  
Aradhana Gupta ◽  
Lindsay Tomlinson ◽  
Niraj Tripathi ◽  
Barbara von Beust
Keyword(s):  
Clinical Pathology ◽  
Veterinary Drug ◽  
Product Regulatory ◽  
Limited Attention ◽  
Data Generation ◽  
Scientific Review ◽  
Target Animal ◽  
Regulatory Affairs ◽  
Safety Studies ◽  
Animal Safety

Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article–related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.

The specifics of shadow economic activity in Russia

2020 ◽  
Vol 19 (10) ◽  
pp. 1896-1915
Author(s):  
E.R. Ermakova ◽  
O.M. Lizina
Keyword(s):  
Economic Activity ◽  
Shadow Economy ◽  
Integrated Approach ◽  
Economic Activities ◽  
Reproductive Process ◽  
Scientific Methods ◽  
Current Period ◽  
Russian Economy ◽  
Analysis And Synthesis ◽  
The Impact

Subject. The article addresses the specifics of shadow economic activities in reformed Russia in the context of systemic transformations. Objectives. We focus on determining the role of shadow economy in the reproductive process, identifying and understanding the specifics of underground economic activity of the Russian economy. Methods. The study rests on general scientific methods (scientific abstraction, unity of historical and logical, analysis and synthesis, induction and deduction, comparison and analogy) and special methods of cognition (monetary methods). We employ the systems and integrated approach. The official statistics, regulations, works of leading researchers on shadow economy expansion, resources of reference and legal systems like Garant and ConsultantPlus serve as the study's information base. Results. We present a retrospective rapid analysis of the extent of shadow economic activity in the domestic economy, establishing the relationships with the processes that take place at different stages of the country's development. We also reveal the specifics of shadow economy relations in Russia, factors that play a key role in expansion for a particular period, a shift to another form of shadow economy. The study characterizes the current period of development, assesses the impact of external shocks on shadow economy expansion. Conclusions. The current period is characterized by the digitization of shadow relations, the shift of corruption to the upper echelons of power, the continued outflow of capital abroad, and increased penalties for underground activities.

Assessing the sustainability of the Siberian Federal District regions

2020 ◽  
Vol 18 (5) ◽  
pp. 891-908
Author(s):  
T.A. Smirnova
Keyword(s):  
Sustainable Development ◽  
Environmental Factors ◽  
Regional Development ◽  
Federal District ◽  
Integrated Approach ◽  
Siberian Federal District ◽  
The Sustainable Development ◽  
The Impact ◽  
Empirical Analyses

Subject. This article deals with the issues of functioning of the region as a system. Objectives. The article aims to identify the problems of the region's functioning as a system, develop methodological tools to monitor the sustainable development of the Siberian Federal District territories, and determine the the impact of socio-economic and environmental factors on the sustainable development of the region as a whole. Methods. For the study, I used the methods of theoretical, statistical, and empirical analyses taking into account an integrated approach. Results. The article reveals the impact of some individual components of regional development on the sustainability of the territorial system as a whole. Relevance. The results of the study can be used to analyze the sustainability of regions' development.

Assessment of sensitivity of the efficiency of regional tax spending towards investment attractiveness of the types of economic activity carried out by the residents of advanced development territory

2020 ◽  
pp. 98-110
Author(s):  
Evgeniya Mikhailovna Popova ◽  
Guzel Mukhtarovna Guseinova ◽  
Sergei Borisovich Milov
Keyword(s):  
Economic Activity ◽  
Socioeconomic Development ◽  
Federal District ◽  
Tax Incentives ◽  
Capital Investments ◽  
The Subject ◽  
Investment Process ◽  
The Impact ◽  
Advanced Development

The deficit of subnational budgets and deceleration capital investments in multiple Russian regions increase the relevance of research aimed at improvement of tax incentivizing practice of the regional investment process. The studies focused on determination of the impact of socioeconomic and institutional factors upon the efficiency of investment tax expenses obtained wide circulation within the foreign scientific literature. The subject of this article is the assessment of sensitivity of the efficiency of regional tax expanses towards investment attractiveness of the types of economic activity carried out by the residents of territories of advanced socioeconomic development, created in the subjects of Far Easter Federal District. The scientific novelty and practical values of this research consists in substantiation of the reasonableness of assessment of investment attractiveness of the types of economic activity that are stimulated by tax incentives. Methodology for assessing investment attractiveness is proposed and tested. The conclusion is made that in case of low investment attractiveness of the type of economic activity, which was planned to support by tax incentives, it is required to conduct and additional analysis to avoid unjustified tax expanses.

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