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Wise L David - - 2013
Relying on previous regulatory guidelines from multiple countries, the ICH S5(R2) guideline outlines the preclinical safety studies needed for registration of new medicinal products in the member countries (European Union, Japan, and the United States). The primary purpose of the guideline is to provide a testing strategy to detect and ...
Anguish Lynne - - 2013
The visualization of subcellular organelles and structures is a valuable tool for understanding cellular changes that occur in oocytes and early embryos as a result of genetic alterations, incubation conditions, drug treatments, and many other manipulations. Preparing oocytes for transmission electron microscopic analysis can be challenging as these cells cannot ...
Vasquez Sergio X - - 2013
Micro-computed tomography imaging technology allows for the whole-mount investigation of skeletal structures in preclinical specimens at both fetal and postnatal time points. The imaging process is nondestructive to the specimen and can be performed at various resolutions to derive the region of interest information most relevant to individual researchers. In ...
Brannen Kimberly C - - 2013
As a model for teratogenicity research, zebrafish are gaining popularity and creditability. Zebrafish embryos have been proven to be a highly valuable tool in genetics and developmental biology research and have advanced our understanding of a number of known developmental toxicants. It has yet to be determined conclusively how reliably ...
Leroy Mariline - - 2013
This chapter describes methods for the examination of fetal abdominal and thoracic soft tissues by microdissection on either fresh (non-rodent) or fixed (rodent) specimens in order to detect structural abnormalities. With hundreds of fetuses examined for each species (rodent and non-rodent) in regulatory reproductive toxicity assessments (ICH, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M3_R2/Step4/M3_R2__Guideline.pdf, 2009; ICH, ...
Riris Solon - - 2013
Understanding how human oocytes execute chromosome segregation is of paramount importance as errors in this process account for the overwhelming majority of human aneuploidies and increase exponentially with advancing female age. The spindle is the cellular apparatus responsible for separating chromosomes at anaphase. For accurate chromosome segregation, spindle microtubules must ...
Marangos Petros - - 2013
Gene silencing techniques have brought new insights into mammalian oocyte and embryo development. More specifically, the use of Morpholino oligonucleotides which sterically inhibit translation from target mRNAs thereby compromising gene function, allowed the identification of important oocyte regulators and especially factors involved in meiotic cell cycle control. Here we describe ...
Barrow Paul C - - 2013
The developmental and reproductive toxicity testing (including teratogenicity) of new foods and food additives is performed worldwide according to the guidelines given in the FDA Redbook. These studies are not required for substances that are generally recognized as safe, according to the FDA inventory. The anticipated cumulated human exposure level ...
Mizutani Eiji - - 2013
The nuclear transfer (NT) technique in the mouse has enabled us to generate cloned mice and to establish NT embryonic stem (ntES) cells. Direct nuclear injection into mouse oocytes with a piezo impact drive unit can aid in the bypass of several steps of the original cell fusion procedure. It ...
Piersma Aldert H - - 2013
Toxicological hazard assessment currently finds itself at a crossroads where the existing classical test paradigm is challenged by a host of innovative approaches. Animal study protocols are being enhanced for additional parameters and improved for more efficient effect assessment with reduced animal numbers. Whilst existing testing paradigms have generally proven ...
Kim James H - - 2013
The current political and societal climate is driving the science of toxicology towards developing non-animal testing methodologies. Though alternative and in vitro tests have always been a mainstay for toxicological testing, technological advances in the last decade have allowed toxicologists to move rapidly towards a better understanding of the relevance ...
Rao K S - - 2013
India and China have booming chemical, agrochemical, and pharmaceutical industries. Both countries also represent expanding markets for foreign chemical and healthcare companies. All such products require reproductive toxicity testing before marketing. The ICH testing guidelines for medicinal products are not applicable in China and India. Nonetheless, reproductive toxicity studies designed ...
Swann Karl - - 2013
At fertilization mammalian eggs are activated by a prolonged series of oscillations in the intracellular free Ca(2+) concentration. These oscillations can be monitored with any number of Ca(2+)-sensitive fluorescent dyes. The oscillations last for several hours at fertilization and so there are some considerations with mammalian eggs that make them ...
Zhang Cindy - - 2013
The rat whole embryo culture (WEC) system has been used extensively for characterizing teratogenic properties of test chemicals. In this chapter, we describe the methodology for culturing rat embryos as well as a new morphological score system, the Dysmorphology Score (DMS) system for assessing morphology of mid gestation (gestational day ...
Hazelden Keith P - - 2013
The characteristics of biologic drugs, as compared with small molecules, confer significant advantages for both the drug developer and the prospective patients. The necessity for, and the timing of, developmental toxicity testing in the preclinical program must be considered. Choice of an appropriate test system is of particular importance, one ...
Chiang Teresa - - 2013
Chromosomal spreads are an established method to assess ploidy in different cell types. However, many traditional chromosome-spreading techniques require dissolution of the cell and can only be used to assess hyperploidy because of potential chromosome loss inherent in the procedure. Here we describe a method to evaluate chromosome numbers in ...
Baltz Jay M - - 2013
Radiolabeled compounds that are substrates for transmembrane transporters can be used to study transport and metabolism in mammalian oocytes and preimplantation embryos. Because even very small amounts of radioisotopes can be detected, these techniques are feasible to use with only a few oocytes or embryos, even down to the level ...
Prutner Wiebke - - 2013
In 2007, a new European chemicals legislation was implemented: Regulation (EC) No. 1907/2006, also known as "REACH." It obliges companies to take the main responsibility for the valid information on the safe use of the chemicals they manufacture and/or place on the European market. So they must, for example, register ...
He Jing - - 2013
The development of primordial germ cells into oocytes within primordial follicles involves a complex sequence of proliferation, developmental commitment, entry and arrest in meiosis, and association with surrounding somatic cells. These processes occur over the first few months of development in the human, with multiple stages of development present at ...
Leroy Mariline - - 2013
The rat is the rodent species of choice for the regulatory safety testing of xenobiotics, such as medicinal products, food additives, and other chemicals. Many decades of experience and extensive data have accumulated for both general and developmental toxicology investigations in this species. The high fertility and large litter size ...
de Boer Esther - - 2013
During meiosis, homologous chromosomes (homologs) undergo recombinational interactions, resulting in the formation of crossovers (COs) or noncrossovers (NCOs). Both COs and NCOs are initiated by the same event: programmed double-strand DNA breaks (DSBs), which occur preferentially at hotspots throughout the genome. COs contribute to the genetic diversity of gametes and ...
Allais Linda - - 2013
The rabbit is generally the non-rodent species or second species after the rat recommended by the regulatory authorities and is part of the package of regulatory reproductive studies for the detection of potential embryotoxic and/or teratogenic effects of pharmaceuticals, chemicals, food additives, and other compounds, including vaccines (see Chapters 1-7).Its ...
Schneider Steffen - - 2013
The assessment of developmental toxicology data is a critical aspect of hazard evaluation for pharmaceuticals and environmental chemicals. Skeletal examination is an essential part of prenatal developmental toxicity studies of chemicals as well as pesticides and comprises evaluation of both cartilaginous and ossified skeletal components. Various techniques are published in ...
Stein Paula - - 2013
RNA interference (RNAi) is an evolutionary conserved gene-silencing pathway that can be efficiently utilized as a tool to study gene function. RNAi is initiated by long double-stranded RNAs (dsRNAs), which are processed into small duplexes called small-interfering RNAs (siRNAs). In turn, these duplexes target mRNAs for degradation in a sequence-specific ...
Marks Leonard - - 2013
Prostate cancer (CaP) may be detected on MRI. Fusion of MRI with ultrasound allows urologists to progress from blind, systematic biopsies to biopsies, which are mapped, targeted and tracked. We herein review the current status of prostate biopsy via MRI/ultrasound fusion. Three methods of fusing MRI for targeted biopsy have ...
Ge Lili - - 2013
Our purpose was to investigate the role of the axial resolution of optical coherence tomography (OCT) on the measurement of corneal and epithelial thickness by evaluating the repeatability and agreement among different OCT devices with different axial resolutions. twenty right eyes of 20 healthy subjects (AGE: 22.3 ± 1.3 years) ...
Gucer Patricia W - - 2013
To determine associations between long-term care powered mechanical lift (PML) availability and mobility-related resident outcomes. Long-term care directors of nursing (N = 271) nationwide gave facility information on the PML availability and the lifting policy to which we linked data on mobility-related resident outcomes from the Centers for Medicare & ...
Sun Xianfei X Department of Biomedical Sciences, Cornell University, Ithaca, NY, - - 2013
Meiosis is the specialized cell division in sexually reproducing organisms in which haploid gametes are produced. Meiotic prophase I is the defining stage of meiosis, when pairing and synapsis occur between homologous chromosomes, concurrent with reciprocal recombination (or crossing over) events that arise between them. Any disruption of these events ...
Kim Ji-hye JH Laboratory of Chromosome Dynamics, Institute of Molecular and Cellular Biosciences, University of Tokyo, Tokyo, - - 2013
Distinct meiotic cohesin complexes play fundamental roles in various meiosis-specific chromosomal events in spatiotemporally different manners during mammalian meiotic prophase. Immunostaining is one of the essential methods to study meiotic cohesin dynamics. For the study of cohesins in the meiotic prophase of oocytes, ovaries should be taken from the embryos ...
McDonell Michael G MG Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. - - 2013
The primary objective of this study was to determine whether contingency management was associated with increased abstinence from stimulant drug use in stimulant-dependent patients with serious mental illness treated in a community mental health center. Secondary objectives were to determine whether contingency management was associated with reductions in use of ...
Gauthier Cindy C Pathokinesiology Laboratory, Center for Interdisciplinary Research in Rehabilitation of Greater Montreal, Institut de réadaptation Gingras-Lindsay-de-Montréal, Montreal, - - 2013
To compare multidirectional seated postural stability between individuals with spinal cord injury and able-bodied- individuals and to evaluate the impact of abdominal and low back muscle paralysis on multidirectional seated stability. Case-control study. Fifteen individuals with complete or incomplete spinal cord injury affecting various vertebral levels participated in this study ...
Rushton Paula W PW Rehabilitation Sciences Graduate Program, University of British Columbia, T325 - 2211 Wesbrook Mall, Vancouver, British Columbia V6T 2B5, - - 2013
To evaluate the measurement properties of the Wheelchair Use Confidence Scale for manual wheelchair users version 2.1 (WheelCon-M 2.1). Cohort study. Volunteer sample of 83 community-dwelling, experienced manual wheelchair users. Participants completed the WheelCon-M 2.1 twice to assess retest reliability. Validity was assessed by evaluating hypothesized relationships between the WheelCon-M ...
Lala A A Department of Medicine, Division of Cardiovascular Medicine, New York University School of Medicine, New York, NY 10016, - - 2013
The CYP2C19 genotype is a predictor of adverse cardiovascular events in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) treated with clopidogrel. We aimed to evaluate the cost-effectiveness of a CYP2C19*2 genotype-guided strategy of antiplatelet therapy in ACS patients undergoing PCI, compared with two 'no testing' strategies (empiric ...
Adeyemo Adebowale A Center for Research on Genomics and Global Health, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, - - 2013
Research in industrialized countries has demonstrated that a key factor limiting the control of hypertension is poor patient adherence and that the most successful interventions for long-term adherence employ multiple strategies. Very little data exist on this question in low-income countries, wherein medication-taking behavior may be less well developed. We ...
Eto Hitomi H Department of Plastic Surgery, University of Tokyo School of Medicine, Tokyo, - - 2013
Adipose tissue (AT) is composed of mature adipocytes and stromal vascular fraction (SVF) cells, including adipose stem/stromal cells (ASCs). We characterized hematopoietic cells residing in human nonobese AT by analyzing the SVF isolated from human lipoaspirates and peripheral blood (PB). Flow cytometry revealed that AT-resident hematopoietic cells consisted of AT-resident ...
Rosengart Todd K TK Division of Cardiothoracic Surgery, Department of Surgery, Stony Brook University Medical Center, Stony Brook, NY 11794, - - 2013
On the basis of studies in experimental animals demonstrating that AdVEGF121, an E1(-)E3(-) serotype 5 adenovirus coding the 121 isoform of vascular endothelial growth factor (VEGF), could mediate the generation of new blood vessels and reverse coronary ischemia, a clinical study of direct myocardial administration of AdVEGF121 was initiated in ...
Zidane Nora N Institut Pasteur, Unit of Molecular Prevention and Therapy of Human Diseases, Department of Infection and Epidemiology, rue du Dr. Roux, F-75015 Paris, - - 2013
The human RPSA [ribosomal protein SA; also known as LamR1(laminin receptor 1)] belongs to the ribosome but is also a membrane receptor for laminin, growth factors, prion, pathogens and the anticarcinogen EGCG (epigallocatechin-gallate). It contributes to the crossing of the blood-brain barrier by neurotropic viruses and bacteria, and is a ...
Ingole Nayana N Department of Microbiology, Seth G. S. Medical College & KEM Hospital, Mumbai, India. - - 2013
In HIV-infected individuals on antiretroviral therapy (ART), the decision on when to switch from first-line to second-line therapy is dictated by treatment failure, and this can be measured in three ways: clinically, immunologically, and virologically. While viral load (VL) decreases and CD4 cell increases typically occur together after starting ART, ...
McDonough C C Department of Health Sciences, University of Leicester, Leicester, - - 2013
The association between obesity and a poorer health-related quality of life (HRQL) has previously been explored. The influence of ethnicity on this relationship has less frequently been considered. We aimed to explore the relationship between body mass index (BMI) and HRQL in a mixed population of White European (WE) and ...
Sroczynski Maureen - - 2012
The Institute of Medicine report and the passage of the Patient Protection and Affordable Care Act present significant opportunities for the nursing profession. As the largest group of primary care providers, nurse practitioners are the critical element in the provision of comprehensive primary care, and a critical element to the ...
Roy Mangal - - 2012
Brushite (dicalcium phosphate dihydrate, DCPD) cement, owing to its high solubility in physiological condition and ability to guide new bone formation, is widely used to treat bone defects. In the present study, we have evaluated the effects of poly ethylene glycol (PEG) addition on the setting time, compressive strength and ...
Giarelli Ellen - - 2012
This article presents an argument for research on the practical outcomes of genetics education in professional nursing programs. Nurse educators should aggressively conduct educational outcomes research on the translation of genetics core competencies at all levels of clinical practice. There should be a systematic examination of the factors, that influence ...
Zhang G-Q - - 2012
Cynomolgus macaques (Macaca fascicularis, Mafa) have emerged as an important animal model for infectious disease and transplantation research. Extensive characterization of their major histocompatibility complex (MHC) polymorphism regions therefore becomes urgently required. In this study, we identified 41 MHC class I A nucleotide sequences in 34 unrelated cynomolgus macaques of ...
Dreher H Michael - - 2012
This article reports on a national study of doctoral nursing faculty, including both PhD and Doctor of Nursing Practice (DNP) faculty. Using a national sample of 624 doctoral nursing faculty, we surveyed individuals on a variety of issues, including succession planning, retirement, quality of life as a doctoral faculty member, ...
Balas A - - 2012
B*44:150 was identical to B*44:02:01:01 except at the 3'-end region of exon 3, where a B*07-specific sequence was identified.
Walsh Brennan Ann Marie - - 2012
This article examines current trends in nursing education and proposes undergraduate curriculum changes that are needed to meet the needs and goals of the Institute of Medicine Report: The Future of Nursing, Leading Change, Advancing Health, and The Patient Protection and Affordable Care Act. Curricular changes were developed and implemented ...
Liu Y - - 2012
This new HLA-B allele differs from the closest allele B*40:01:01 by two nucleotide changes at codons 102 and 267.
Mainous Rosalie O - - 2012
With the graying of the professoriate, many deans in nursing are moving toward retirement, which provides an opportunity for emerging leaders to move into deanships. New deans move through predictable stages and enjoy a honeymoon, allowing for some mistakes that might not be tolerated later. Early wins are essential in ...
Fontaine Dorrie K - - 2012
Promoting a healthy workplace in academic nursing settings is vital to recruit new faculty and enhance the work life of all faculty and staff for retention and happiness. When a healthy work environment is fostered, incivility becomes unacceptable, and individuals embrace a culture where all can flourish. This article addresses ...
Corsini Alberto - - 2012
Current key challenges and controversies encountered in the identification of potentially hepatotoxic drugs and the assessment of drug-induced liver injury (DILI) are covered in this article. There is substantial debate over the classification of DILI itself, including the definition and validity of terms such as 'intrinsic' and 'idiosyncratic'. So-called idiosyncratic ...
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