Intraperitoneal Route of Drug Administration: Should it Be Used in Experimental Animal Studies?

Abstract For many endocrine-disrupting chemicals (EDCs) including Bisphenol A (BPA), animal studies show that environmentally relevant exposures cause harm; human studies are consistent with these findings. Yet, regulatory agencies charged with protecting public health continue to conclude that human exposures to these EDCs pose no risk. One reason for the disconnect between the scientific consensus on EDCs in the endocrinology community and the failure to act in the regulatory community is the dependence of the latter on so-called “guideline studies” to evaluate hazards, and the inability to incorporate independent scientific studies in risk assessment. The Consortium Linking Academic and Regulatory Insights on Toxicity (CLARITY) study was intended to bridge this gap, combining a “guideline” study with independent hypothesis-driven studies designed to be more appropriate to evaluate EDCs. Here we examined an aspect of “guideline” studies, the use of so-called “historical controls,” which are essentially control data borrowed from prior studies to aid in the interpretation of current findings. The US Food and Drug Administration authors used historical controls to question the plausibility of statistically significant BPA-related effects in the CLARITY study. We examined the use of historical controls on 5 outcomes in the CLARITY “guideline” study: mammary neoplasms, pituitary neoplasms, kidney nephropathy, prostate inflammation and adenomas, and body weight. Using US Food and Drug Administration–proposed historical control data, our evaluation revealed that endpoints used in “guideline” studies are not as reproducible as previously held. Combined with other data comparing the effects of ethinyl estradiol in 2 “guideline” studies including CLARITY-BPA, we conclude that near-exclusive reliance on “guideline” studies can result in scientifically invalid conclusions.

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Evaluation of the Impacts of Chemotherapeutics on Odontogenesis Process: Findings from a Systematic Review

Journal of Morphological Sciences ◽

10.1055/s-0039-1688810 ◽

2019 ◽

Vol 36 (03) ◽

pp. 210-218

Author(s):

Camila Valente Smith ◽

Grazyelle Sebrenski da Silva ◽

Felipe Rodolfo Pereira da Silva ◽

José Fernando Marques Barcellos ◽

Silvânia da Conceição Furtado

Keyword(s):

Systematic Review ◽

Experimental Animal ◽

Observational Studies ◽

Animal Studies ◽

Direct Analysis ◽

The Other ◽

Cochrane Library ◽

Oncology Patient ◽

Therapeutic Protocol ◽

The Individual

AbstractThis study aimed to examine and recognize the impacts of antinoplastic chemotherapeutics on the development of dental germ, employing a systematic review. A retrieving in the literature was carried out, using several medical and scientifical databases (ClinicalKey, Cochrane Library, Google Scholar, MedLine, PubMed, and ScienceDirect), by two investigators separately. In the end of this systematic search, eight articles met the required criteria for inclusion and, therefore, composed the results. Among these, four articles are about observational studies in humans, and the other four about experimental animal studies. In both cases and species, anomalies such as microdontia, hypodontia/agenesia, and root shortening were observed. The severity and frequency varied according to the nature of the chemotherapeutics applied as well as the administered dosage and the patient's age at the time of first exposure. Through the results, it was possible to show the direct impacts of chemotherapy on the odontogenesis process as well as factors such as the type of chemotherapy, the age of the individual at the time of first exposure and the dosage used. All of those should be taken into account when choosing a therapeutic protocol for an oncology patient. Besides, we observed the need for more studies in this area and that these should be standardized in order to allow an objective and direct analysis of comparable parameters, even when different approaches are used.

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The Determination and Evaluation of Capillary Resistance—A Review of Methodology

Blood ◽

10.1182/blood.v20.1.83.83 ◽

1962 ◽

Vol 20 (1) ◽

pp. 83-93 ◽

Cited By ~ 9

Author(s):

JENÖ KRAMÁR

Keyword(s):

Experimental Animal ◽

Clinical Studies ◽

Animal Studies ◽

Underlying Mechanism ◽

Short Intervals ◽

Pressure Method ◽

Capillary Resistance ◽

Erroneous Interpretation

Abstract In view of the uncertainty and inadequacy still prevailing in the routine determination and interpretation of capillary resistance, the problem has been analyzed in the hope of contributing to a much needed improvement. (1) The pressure and suction methods have been compared and a good correlation found. A study of the mechanisms involved reveals that both methods rest upon a common underlying mechanism. The suction method is in reality a miniature pressure method. (2) Scrutiny of the merits and shortcomings of the two methods leads to the conclusion that the pressure method can serve only for crude estimations of capillary resistance. Detailed clinical studies of capillary resistance requiring repeated accurate measurements at short intervals, as well as experimental animal studies, necessitate the suction method as the obvious method of choice. (3) The three main causes of the present undesirable situation in this field are discussed: lack of standardization; inadequate realization of the pitfalls of testing; and erroneous interpretation of findings.

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The complementary interaction of epidemiological and experimental animal studies: A key foundation of the preventive effort

Preventive Medicine ◽

10.1016/0091-7435(83)90175-5 ◽

1983 ◽

Vol 12 (1) ◽

pp. 84-99 ◽

Cited By ~ 3

Author(s):

R.W. Wissler ◽

D. Vesselinovitch

Keyword(s):

Experimental Animal ◽

Animal Studies ◽

Preventive Effort

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Sex and gender differences in hypertensive kidney injury

AJP Renal Physiology ◽

10.1152/ajprenal.00206.2017 ◽

2017 ◽

Vol 313 (4) ◽

pp. F1009-F1017 ◽

Cited By ~ 18

Author(s):

Jennifer C. Sullivan ◽

Ellen E. Gillis

Keyword(s):

Sex Differences ◽

Experimental Animal ◽

Animal Studies ◽

Molecular Mechanisms ◽

Kidney Injury ◽

Science Research ◽

The United States ◽

Sex And Gender ◽

Participation Of Women ◽

And Gender

Hypertension is a complex, multifaceted disorder, affecting ~1 in 3 adults in the United States. Although hypertension occurs in both men and women, there are distinct sex differences in the way in which they develop hypertension, with women having a lower incidence of hypertension until the sixth decade of life. Despite observed sex differences in hypertension, little is known about the molecular mechanisms underlying the development of hypertension in females, primarily because of their underrepresentation in both clinical and experimental animal studies. The first goal of this review is to provide a concise overview of the participation of women in clinical trials, including a discussion of the importance of including females in basic science research, as recently mandated by the National Institutes of Health. The remaining portion of the review is dedicated to identifying clinical and experimental animal studies that concentrate on gender and sex differences in hypertensive kidney disease, ending with a proposed role for T cells in mediating sex differences in blood pressure.

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Experimental animal studies of clip-induced microvascular trauma

Microsurgery ◽

10.1002/micr.20016 ◽

2004 ◽

Vol 24 (3) ◽

pp. 241-247 ◽

Cited By ~ 6

Author(s):

Thomas S. Kühnel ◽

Gottfried H. Müller

Keyword(s):

Experimental Animal ◽

Animal Studies

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