scholarly journals In vitro genotoxicity test package of antibiotics for human use submitted to the Japanese regulatory agency during 2004–2015

2017 ◽  
Vol 4 (5) ◽  
pp. 241-245
Author(s):  
Shin-ichi Sekizawa ◽  
Yukiko Hoshino ◽  
Aiko Takasu
Keyword(s):  
Regulatory Agency ◽  
Genotoxicity Test ◽  
Human Use ◽  
Test Package

scholarly journals Importance of color stability of the esthetic restoration materials

2021 ◽  
Vol 8 (12) ◽  
pp. 6096
Author(s):  
Thuraya Abdulrahim Basudan ◽  
Ibrahim Alhussain Bahshan ◽  
Mohammed Khashman Almutairi ◽  
Nwaf Ahmed Alkadi ◽  
Jehad Aymen Al Qiriaqri ◽  
...  
Keyword(s):  
Dental Care ◽  
Dental Health ◽  
Health Sector ◽  
Color Stability ◽  
Vital Role ◽  
Medical Treatments ◽  
The Public ◽  
Human Use

Color stability has a vital role in several factors. Including the cosmetic appearance, confidence while smiling, and facial emotions, and in some patients, it denoted healthy and vital dental health. Dental discoloration denotes the lack of dental care. This varies from excessive use of external artificial coloration materials such as coffee, tea, and fizzy drinks. Also, in some cases, the dental discoloration is due to internal pathological conditions or due to medical treatments usage. Radiation has been remarked as one of the causes that cause dental discoloration. In addition to that, chemotherapy was also associated with dental discoloration. Some medications, such as tetracycline and antihistamines, were linked to dental discoloration. The literature discussed in-vitro experiments for the substances affecting the teeth' color status. Coffee was the most significant cause for dental discoloration, either human use (in-vivo) or laboratory experiments (in-vitro). The sociodemographic status was linked to the variance of dental discoloration. Future recommendations are concerned about the public health sector. The WHO should offer comprehensive dental care for all people all over the world, and not exclusive for specific socioeconomic areas. Practical plans for screening dental pathologies should be investigated and for systematic pathologies that might be associated with dental issues.  

scholarly journals Limiting Ischemic Injury by Inhibition of Excitatory Amino Acid Release

1993 ◽  
Vol 13 (1) ◽  
pp. 88-97 ◽  
Author(s):  
Steven H. Graham ◽  
Jun Chen ◽  
Frank R. Sharp ◽  
Roger P. Simon
Keyword(s):  
Excitatory Amino Acid ◽  
Glutamate Release ◽  
Ischemic Injury ◽  
Retrosplenial Cortex ◽  
Mca Occlusion ◽  
Alternative Approach ◽  
Proximal Middle Cerebral Artery ◽  
Human Use ◽  
Unacceptable Toxicity

Excitatory amino acids (EAAs) are important mediators of ischemic injury in stroke. N-Methyl-d-aspartate (NMDA) receptor antagonists have been shown to be very effective neuroprotective agents in animal models of stroke, but may have unacceptable toxicity for human use. An alternative approach is to inhibit the release of EAAs during stroke. BW1003C87 [5-(2,3,5-trichlorophenyl)-2,4-diaminopyrimidine], a drug that inhibits veratrine-induced release of the EAA glutamate in vitro, was tested in a rat model of proximal middle cerebral artery (MCA) occlusion. BW1003C87 significantly decreased ischemia-induced glutamate release in brain when given either 5 min before or 15 min following permanent MCA occlusion. Pretreated and posttreated rats had smaller infarct volumes and preserved glucose metabolism in the ischemic cortex at 24 h after MCA occlusion. BW1003C87 did not induce heat shock protein in the cingulate or retrosplenial cortex, suggesting that it does not injure neurons in these regions as do NMDA antagonists. These results demonstrate that drugs that inhibit glutamate release in ischemia may be nontoxic and show promise for the treatment of stroke.

scholarly journals Safety of Mesenchymal Stem Cells for Clinical Application

2012 ◽  
Vol 2012 ◽  
pp. 1-4 ◽  
Author(s):  
Youwei Wang ◽  
Zhi-bo Han ◽  
Yong-ping Song ◽  
Zhong Chao Han
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Regenerative Medicine ◽  
Therapeutic Agents ◽  
Great Promise ◽  
Safety Issues ◽  
Human Use

Mesenchymal stem cells (MSCs) hold great promise as therapeutic agents in regenerative medicine and autoimmune diseases, based on their differentiation abilities and immunosuppressive properties. However, the therapeutic applications raise a series of questions about the safety of culture-expanded MSCs for human use. This paper summarized recent findings about safety issues of MSCs, in particular their genetic stability in long-termin vitroexpansion, their cryopreservation, banking, and the role of serum in the preparation of MSCs.

Heparin Standardization

1979 ◽  
Author(s):  
T. Exner ◽  
E. Uhr ◽  
K.A. Rickard
Keyword(s):  
Continuous Infusion ◽  
Factor Xa ◽  
Clinical Results ◽  
The Other ◽  
Animal Blood ◽  
Dose Heparin ◽  
Normal Plasma ◽  
Straight Line ◽  
Human Use

Heparin is a major therapeutic item in any hospital and although local supplies are assumed to meet BP criteria, physicians often note differences in clinical results when the source of a supply is altered. BP and USP specifications require testing of heparins using animal blood thromboplastin tests - conditions which may not be particularly relevant to human use. A new method for determining heparin potency relative to a standard involves making equal dilutions of these heparins in several patients’ plasmas and determining the PTTK’s. The ratios of these PTTK’s to the initial PTTK of each plasma, when plotted for one heparin against the other, fall on a straight line and may be treated in the same way as recently proposed for thromboplastin calibration by the WHO. Features of heparin vary in importance depending on the particular application. Heparin used at high levels during bypass should be completely neutralizable by protamine. Mini-dose heparin needs to be standardised in terms of factor xa inactivation rate whereas that used for routine continuous infusion might best be standardised from its effect in vitro on the PTTK of normal plasma. We have recently investigated 3 tests for assessing heparins. 1. effect of their in vitro addition on the PTTK of normal plasma. 2. effect on factor xa inactivation. 3. protamine neutralisability as detected by the PTTK. The latter test was most accurate, demonstrating significant differences between sources of heparin and detecting variations in batch potency previously suspected by clinicians.

scholarly journals Immunization with a Polyprotein Vaccine Consisting of the T-Cell Antigens Thiol-Specific Antioxidant, Leishmania major Stress-Inducible Protein 1, and Leishmania Elongation Initiation Factor Protects against Leishmaniasis

2002 ◽  
Vol 70 (8) ◽  
pp. 4215-4225 ◽  
Author(s):  
Rhea N. Coler ◽  
Yasir A. W. Skeiky ◽  
Karen Bernards ◽  
Kay Greeson ◽  
Darrick Carter ◽  
...  
Keyword(s):  
Leishmania Major ◽  
Initiation Factor ◽  
Interleukin 12 ◽  
Effective Vaccine ◽  
Preclinical Model ◽  
Tandem Fusion ◽  
T Cell Antigens ◽  
Human Use ◽  
Inducible Protein

ABSTRACT Development of an effective vaccine against Leishmania infection is a priority of tropical disease research. We have recently demonstrated protection against Leishmania major in the murine and nonhuman primate models with individual or combinations of purified leishmanial recombinant antigens delivered as plasmid DNA constructs or formulated with recombinant interleukin-12 (IL-12) as adjuvant. In the present study, we immunized BALB/c mice with a recombinant polyprotein comprising a tandem fusion of the leishmanial antigens thiol-specific antioxidant, L. major stress-inducible protein 1 (LmSTI1), and Leishmania elongation initiation factor (LeIF) delivered with adjuvants suitable for human use. Aspects of the safety, immunogenicity, and vaccine efficacy of formulations with each individual component, as well as the polyprotein referred to as Leish-111f, were assessed by using the L. major challenge model with BALB/c mice. No adverse reactions were observed when three subcutaneous injections of the Leish-111f polyprotein formulated with either MPL-squalene (SE) or Ribi 529-SE were given to BALB/c mice. A predominant Th1 immune response characterized by in vitro lymphocyte proliferation, gamma interferon production, and immunoglobulin G2A antibodies was observed with little, if any, IL-4. Moreover, Leish-111f formulated with MPL-SE conferred immunity to leishmaniasis for at least 3 months. These data demonstrate success at designing and developing a prophylactic leishmaniasis vaccine that proved effective in a preclinical model using multiple leishmanial antigens produced as a single protein delivered with a powerful Th1 adjuvant suitable for human use.

Sorbinil, an Aldose Reductase Inhibitor, in Fighting Against Diabetic Complications

2019 ◽  
Vol 15 (1) ◽  
pp. 3-7 ◽  
Author(s):  
Qi Huang ◽  
Qiong Liu ◽  
Dongsheng Ouyang
Keyword(s):  
Aldose Reductase ◽  
Diabetic Complications ◽  
Polyol Pathway ◽  
Review Article ◽  
Global Public Health ◽  
Model Studies ◽  
Human Use ◽  
Pathway Inhibition

Background: Aldose reductase (AR) is involved in the pathogenesis of diabetes, which is one of the major threats to global public health. Objective: In this review article, we have discussed the role of sorbinil, an AR inhibitor (ARI), in preventing diabetic complications. Results: AR contributes in diabetes by generating excess intracellular superoxide and other mediators of oxidative stress through polyol pathway. Inhibition of AR activity thus might be a potential approach for the management of diabetic complications. Experimental evidences indicated that sorbinil can decrease AR activity and inhibit polyol pathway. Both in vitro and animal model studies reported the efficacy of sorbinil in controlling the progression of diabetes. Moreover, Sorbinil has been found to be comparatively safer than other ARIs for human use. But, it is still in earlyphase testing for the treatment of diabetic complications clinically. Conclusion: Sorbinil is an effective ARI, which could play therapeutic role in treating diabetes and diabetic complications. However, advanced clinical trials are required for sorbinil so that it could be applied with the lowest efficacious dose in humans.

Plant propagation.

2021 ◽  
Author(s):  
Vicki Cottrell
Keyword(s):  
Plant Breeding ◽  
Plant Species ◽  
Vegetative Propagation ◽  
Parent Plant ◽  
Plant Propagation ◽  
Asexual Propagation ◽  
Storage Organs ◽  
Sexual Propagation ◽  
Human Use

Abstract It is thought that plant propagation, i.e. multiplying plants, preserving their qualities, and tending them, began approx. 10,000 years ago when people began to cultivate plants for food and other products (Hartman et al., 2010). Most basic methods of plant propagation had been discovered before the start of recorded history, and many plant species had already been domesticated (selected and adapted to human use), including cereals and legumes (Hartman et al., 2010). The two main types of plant propagation are sexual and asexual propagation. Sexual propagation usually involves the production of seed, leading to production of progeny with variable characteristics, so it is often used in plant breeding. Asexual propagation leads to clones of the parent plant and is useful when specific characteristics are desired in the new plants. There are many different forms of asexual or vegetative propagation, including cuttings, grafting, division, storage organs and in vitro techniques.

Preparation of a partially desialylated human chorionic gonadotrophin (hCG) and its use for induction of ovulation after ovarian stimulation with human menopausal gonadotrophin

1980 ◽  
Vol 95 (2) ◽  
pp. 232-236 ◽  
Author(s):  
P. G. Crosignani ◽  
P. Donini ◽  
G. C. Lombroso ◽  
S. Donini ◽  
A. Caccamo ◽  
...  
Keyword(s):  
Large Scale ◽  
Chorionic Gonadotrophin ◽  
Human Chorionic Gonadotrophin ◽  
Human Beings ◽  
Large Scale Preparation ◽  
Human Menopausal Gonadotrophin ◽  
Scale Preparation ◽  
Human Use ◽  
Sepharose 4B

Abstract. A method for the large scale preparation of partially desialylated human chorionic gonadotrophin suitable for human use is reported. To obtain the desired grade of desialylation and to avoid the presence of the enzyme in the modified hormone, neuraminidase coupled to Sepharose 4B was used. The preparation showed to be active in vitro (OAAD and SVW tests) and its half-life was found to be 13 min in the rat and 75 min in human beings. This desialo hCG proved to be effective in inducing ovulation in amenorrhoeic women. Among 39 induced cycles 31 ovulations and 5 pregnancies occurred.

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