scholarly journals A Proposal for new Quality attributes for Schedule R of the Indian Drugs and Cosmetics Act, 1940

2021 ◽  
Vol 9 (1) ◽  
pp. 10-14
Author(s):  
Bayya Subba Rao

Original sin is not life but it is a part of life.  It establishes psychological, mental and physical health.  Statistics reveal several deaths of pregnant mothers, ectopic pregnancy, child deaths or original sin related diseases, apart from lethal consequences which is out of the scope of this article. Use of contraceptive methods may be beneficial in several circumstances avoiding unwanted pregnancies. A few television channels were scrolling the various contraceptive methods and educating the citizens for a good health perspective.  The objective of this review is not only to enlighten the various contraceptive methods but also in knowing their failure level methods and some unique evaluation methods that can be included in Schedule R of the Drugs and Cosmetics Act, 1940 so as to append the quality attributes with in-vitro and in-vivo original sin correlated models.  The review illustrates role of researchers/pharmacist/medical professionals in problem solving skills and is also expected to answer the general questions experienced and witnessed by the author relating to original sin including gender sensitization.  In India, several national level bodies also insist for academic accreditations the contributions relating to gender sensitization and the article meets criteria as well.  If the author as a common man sends a sample for current products for assessing abstract attributes, does Central Drugs Laboratory can?, a thought in this direction is needed which in turn indicates role of questionnaires/instruments in the Drugs and Cosmetics Act, 1940 and Rules 1945.  Does a need of a statutory warning for original sin products is necessary, a question is raised and a review by persons skilled in art is proposed.  The article illustrates either side to the context.  The article also helps to overcome barriers from society, professional point of view relating to original sin related research either at the pre-clinical or at the clinical levels.

2020 ◽  
Author(s):  
SUTHAN PERMUAL ◽  
GAUTHAM KOLLURI ◽  
JAG MOHAN ◽  
RAM SINGH ◽  
JAGBIR TYAGI

Abstract Bisphenol-A, is one of the most characterized endocrine disruptors on the reproductive functions in humans and animals. We have previously reported in vitro and in vivo effects of bisphenol-A on functional role of sperm in chicken. Here, the effects of 1 and 5 mg/kg bisphenol-A daily administered by gavage for 3 wk to adult male Japanese quails on reproductive functionality was investigated. Cloacal index and foam frequency were greatly reduced at high dose. Sperm quality attributes were affected at both doses. Sperm quality attributes were affected at both doses. Alkaline phosphatase showed most significant reduction among seminal enzymes. Dose dependent response (P < 0.01) of bisphenol-A was noticed with modulating testosterone concentrations at low and high doses. Disturbances regarding fertility and hatchability traits were prominent in high and low dose groups. The current study confirms the compromising actions of bisphenol-A on reproductive success in male Japanese quails at lower doses that are considered to be safe (50 mg/kg BW/d) under in vivo exposure module. These results indicate higher sensitivity of quails to bisphenol-A toxicity and explores the possibility of using quail subjects as an accurate toxic indicators.


1967 ◽  
Vol 126 (6) ◽  
pp. 989-1004 ◽  
Author(s):  
R. A. Lerner ◽  
R. J. Glassock ◽  
Frank J. Dixon

These observations established the presence of anti-GBM antibodies in the sera and/or kidneys of six humans with glomerulonephritis. Further, it seems clear that these antibodies do combine with the host's glomeruli in vivo and with GBM antigen of several species in vitro. Transfer of acute glomerulonephritis to normal recipient monkeys was possible with serum or renal eluate IGG from the three patients with anti-GBM antibodies in whom sufficient material was available. Based on this transfer of nephritis and on the presence of these antibodies at the site of injury in the nephritic kidneys of both the patients and the recipient monkeys, it seems likely that they are at least a contributing, if not primary, cause of the glomerular injury. The frequency of anti-GBM antibodies in human nephritis is not certain, but on the basis of preliminary observations it would appear that they are present in all cases of Goodpasture's nephritis and somewhat less than half of the cases of subacute and chronic glomerulonephritis of adults. The nature and source of immunogen stimulating the production of anti-GBM antibodies is not known, but the presence of potentially nephritogenic GBM antigens in normal urine raises the question of possible autoimmunization. From a practical point of view, it appears that patients forming anti-GBM antibodies may not be good candidates for renal transplantation since they are likely to produce in the transplants the nephritic changes already suffered by their own kidneys.


2012 ◽  
Vol 82 (3) ◽  
pp. 228-232 ◽  
Author(s):  
Mauro Serafini ◽  
Giuseppa Morabito

Dietary polyphenols have been shown to scavenge free radicals, modulating cellular redox transcription factors in different in vitro and ex vivo models. Dietary intervention studies have shown that consumption of plant foods modulates plasma Non-Enzymatic Antioxidant Capacity (NEAC), a biomarker of the endogenous antioxidant network, in human subjects. However, the identification of the molecules responsible for this effect are yet to be obtained and evidences of an antioxidant in vivo action of polyphenols are conflicting. There is a clear discrepancy between polyphenols (PP) concentration in body fluids and the extent of increase of plasma NEAC. The low degree of absorption and the extensive metabolism of PP within the body have raised questions about their contribution to the endogenous antioxidant network. This work will discuss the role of polyphenols from galenic preparation, food extracts, and selected dietary sources as modulators of plasma NEAC in humans.


Planta Medica ◽  
2012 ◽  
Vol 78 (11) ◽  
Author(s):  
HM Lee ◽  
TG Ahn ◽  
CW Kim ◽  
HJ An
Keyword(s):  

1987 ◽  
Vol 26 (01) ◽  
pp. 1-6 ◽  
Author(s):  
S. Selvaraj ◽  
M. R. Suresh ◽  
G. McLean ◽  
D. Willans ◽  
C. Turner ◽  
...  

The role of glycoconjugates in tumor cell differentiation has been well documented. We have examined the expression of the two anomers of the Thomsen-Friedenreich antigen on the surface of human, canine and murine tumor cell membranes both in vitro and in vivo. This has been accomplished through the synthesis of the disaccharide terminal residues in both a and ß configuration. Both entities were used to generate murine monoclonal antibodies which recognized the carbohydrate determinants. The determination of fine specificities of these antibodies was effected by means of cellular uptake, immunohistopathology and immunoscintigraphy. Examination of pathological specimens of human and canine tumor tissue indicated that the expressed antigen was in the β configuration. More than 89% of all human carcinomas tested expressed the antigen in the above anomeric form. The combination of synthetic antigens and monoclonal antibodies raised specifically against them provide us with invaluable tools for the study of tumor marker expression in humans and their respective animal tumor models.


1971 ◽  
Vol 66 (3) ◽  
pp. 558-576 ◽  
Author(s):  
Gerald Burke

ABSTRACT A long-acting thyroid stimulator (LATS), distinct from pituitary thyrotrophin (TSH), is found in the serum of some patients with Graves' disease. Despite the marked physico-chemical and immunologic differences between the two stimulators, both in vivo and in vitro studies indicate that LATS and TSH act on the same thyroidal site(s) and that such stimulation does not require penetration of the thyroid cell. Although resorption of colloid and secretion of thyroid hormone are early responses to both TSH and LATS, available evidence reveals no basic metabolic pathway which must be activated by these hormones in order for iodination reactions to occur. Cyclic 3′, 5′-AMP appears to mediate TSH and LATS effects on iodination reactions but the role of this compound in activating thyroidal intermediary metabolism is less clear. Based on the evidence reviewed herein, it is suggested that the primary site of action of thyroid stimulators is at the cell membrane and that beyond the(se) primary control site(s), there exists a multifaceted regulatory system for thyroid hormonogenesis and cell growth.


2018 ◽  
Vol 8 (3) ◽  
pp. 36-41
Author(s):  
Diep Do Thi Hong ◽  
Duong Le Phuoc ◽  
Hoai Nguyen Thi ◽  
Serra Pier Andrea ◽  
Rocchitta Gaia

Background: The first biosensor was constructed more than fifty years ago. It was composed of the biorecognition element and transducer. The first-generation enzyme biosensors play important role in monitoring neurotransmitter and determine small quantities of substances in complex matrices of the samples Glutamate is important biochemicals involved in energetic metabolism and neurotransmission. Therefore, biosensors requires the development a new approach exhibiting high sensibility, good reproducibility and longterm stability. The first-generation enzyme biosensors play important role in monitoring neurotransmitter and determine small quantities of substances in complex matrices of the samples. The aims of this work: To find out which concentration of polyethylenimine (PEI) exhibiting the most high sensibility, good reproducibility and long-term stability. Methods: We designed and developed glutamate biosensor using different concentration of PEI ranging from 0% to 5% at Day 1 and Day 8. Results: After Glutamate biosensors in-vitro characterization, several PEI concentrations, ranging from 0.5% to 1% seem to be the best in terms of VMAX, the KM; while PEI content ranging from 0.5% to 1% resulted stable, PEI 1% displayed an excellent stability. Conclusions: In the result, PEI 1% perfomed high sensibility, good stability and blocking interference. Furthermore, we expect to develop and characterize an implantable biosensor capable of detecting glutamate, glucose in vivo. Key words: Glutamate biosensors, PEi (Polyethylenimine) enhances glutamate oxidase, glutamate oxidase biosensors


The role of vitamin D is implicated in carcinogenesis through numerous biological processes like induction of apoptosis, modulation of immune system inhibition of inflammation and cell proliferation and promotion of cell differentiation. Its use as additional adjuvant drug with cancer treatment may be novel combination for improved outcome of different cancers. Numerous preclinical, epidemiological and clinical studies support the role of vitamin D as an anticancer agent. Anticancer properties of vitamin D have been studied widely (both in vivo and in vitro) among various cancers and found to have promising results. There are considerable data that indicate synergistic potential of calcitriol and antitumor agents. Possible mechanisms for modulatory anticancer activity of vitamin D include its antiproliferative, prodifferentiating, and anti-angiogenic and apoptic properties. Calcitriol reduces invasiveness and metastatic potential of many cancer cells by inhibiting angiogenesis and regulating expression of the key molecules involved in invasion and metastasis. Anticancer activity of vitamin D is synergistic or additive with the antineoplastic actions of several drugs including cytotoxic chemotherapy agents like paclitaxel, docetaxel, platinum base compounds and mitoxantrone. Benefits of addition of vitamin D should be weighed against the risk of its toxicity.


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