Volume 10 | Issue 4 |

 Abstract

Most developed nations require drug manufacturer to prove that their formulations are bioequivalent to their brand name counterparts. Bioequivalence does not mean generic drugs must be exactly the same as the brand name product, chemical differences may exist Hatch Waxman act, standardized procedures for recognition of generic drugs. Before a company can market a generic drug, it needs to file an abbreviated new drug application (ANDA) with the food and drug administration. These products cannot be entirely identical because of batch-to-batch variability and their biological nature, and they are subject to extra rules. FDA also recognizes drugs that use the same ingredients with different bioavailability and divides them into therapeutic equivalence groups. Each year, drug makers lose exclusivity for popular medicines, forcing them to constantly research and launch new drugs to stay afloat. The FDAs purpose is to promote international harmonization of technical and scientific standards for generic medicine development. According to precedence research, the global generic drugs market was worth $390.57 billion in 2020 and is projected to reach approximately $574.63 billion by 2030, attaining a compound annual growth rate (CAGR) of 5.59 percent between 2021 and 2030. Generic cost around 40 to 60 percent less, and you get the same strength, dosage and quality of medication. Generic drug approval review in Japan is conducted by the pharmaceuticals and medical devices agency (PMDA), which reviews the equivalence of the original drugs. The original drugs are given the reexamination period of 8 years at the time of approval. The applicant can apply for the generic drugs after the reexamination period of original drugs. To manufacture and market generic drugs, unlike the original drug, there is no need to conduct clinical trials to verify efficacy and safety of the active ingredients.

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Creative Commons Attribution 4.0 and The Open Definition

 Keywords

: abbreviated new drug application, generic drug application, USFDA, PMDA, office of generic drug, CTD Modules

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Creative Commons Attribution 4.0 and The Open Definition

 Abstract

The effect of socio-demographic characteristics, habits, and other diseases on cancer is studied. The Pearson's Chi-square test and Likelihood Ratio Test are used. There is no association between caste, Marital Status, family history, and "Type of Cancer". In the case of habits, there is no significant association between snuff and Veg/Non-Veg with the type of cancer. The other diseases which are associated with cancer are Diabetes, Obesity, Hepatitis B and C virus infections, Vitamin B6 Deficiency and Chronic bladder inflammation. First, we discussed the effect of socio-demographic characteristics on the type of cancer using the multinomial logistic regression model. Secondly, we studied the effect of habits on the type of cancer using the multinomial logistic regression model. Finally, the study of the effects of other diseases on type of cancer using the multinomial regression model was studied. During the study, stomach cancer was taken as a reference category.

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Creative Commons Attribution 4.0 and The Open Definition

 Keywords

Logistic Regression Model, Significance, Hypothesis, Analysis, socio-demographic characteristics, habits, significant association, factors.

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Creative Commons Attribution 4.0 and The Open Definition

 Abstract

Licence: creative commons attribution 4.0

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Creative Commons Attribution 4.0 and The Open Definition

 Keywords

treadmill, lapifit, speed. bicycle

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Creative Commons Attribution 4.0 and The Open Definition

 Abstract

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Creative Commons Attribution 4.0 and The Open Definition

 Keywords

social media, Online consumption, Self -Congruity, Self-image

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Creative Commons Attribution 4.0 and The Open Definition

 Abstract

The many people are now willing to separate from joint family to nuclear family leading to changes in their social values as required when a collective society transforms to an individualistic society. As such they had to face many problems in the individualistic society. The consequence of individualism includes greater field independence, more wealth, but also greater alienation and competition. Under the above circumstances, impact on self and its development in present scenario, was tremendous one. Thus, this issue needs a systematic study for the management of human resources and for the advancement of human society. In this connection, the structure and function of urban family provided the background of this study.

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Creative Commons Attribution 4.0 and The Open Definition

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nuclear family, married, unmarried, migrated

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Creative Commons Attribution 4.0 and The Open Definition

 Abstract

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Creative Commons Attribution 4.0 and The Open Definition

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Ramayana,Theatre of Aisa, Ramleela,Tradtion of Ramayana,Ramayana Ballet,Silk Route

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Creative Commons Attribution 4.0 and The Open Definition

 Abstract

Lie detection. Facial micro-expressions are an impossible participatory response that is impossible to lie. Liars experience pressure that manifests itself as body language indicators and oral indicators. Small facial expressions are found and known based on Paul Ekman's research using Key Analysis. This paper proposes a non-invasive and economically friendly method to detect lies from people seen as a threat to society.

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Creative Commons Attribution 4.0 and The Open Definition

 Keywords

Liedetection , microexpression

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Creative Commons Attribution 4.0 and The Open Definition

 Abstract

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Creative Commons Attribution 4.0 and The Open Definition

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Keywords: Abbas Mahmud al-Aqqad, Diwan Movement, Intellectual domain, literary criticism

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Creative Commons Attribution 4.0 and The Open Definition

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The Plain English Movement refers to the efforts to make legal documents more accessible to the general public by simplifying the language used. This paper analyses the practicality of its objectives of this movement. It studies this practicality in two areas: the first being the simplification of languages used in legal statutes while the other half focus on the practicality of replacing legalese for plain English inside the courtrooms. The value of legalese which has been used for generations cannot be disregarded; but there is a need for simplifying the language used in statutes especially when the statute requires direct participation of the people. However, in courtrooms the lawyers must have utmost freedom to rely on legalese as all concerned are trained in this language. Moreover, legal terms are often built on a history of legal doctrines and case laws, so when a lawyer uses a specific term, he summons the relevancy of these doctrines and case laws to make his point. The plain English language generally lacks these legal implications and if the lawyers want to make these legal implications with the use of plain language, it often results in a vague and time consuming task. But legal language must be used with due care as the excessive use may render any document incomprehensible.

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Creative Commons Attribution 4.0 and The Open Definition

 Keywords

Plain English movement, legalese, legal language, jargons, plain English, law.

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Creative Commons Attribution 4.0 and The Open Definition

 Abstract

In this paper a new sets called PYTHAGOREAN NEUTROSOPHIC REFINED PRE OPEN SET& PYTHAGOREAN NEUTROSOPHIC REFINED PRE CLOSED SET are introduced and applied to Pythagorean Neutrosophic Refined Topological spaces and some of the basic definitions and theorems are introduced and explained with suitable examples

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Creative Commons Attribution 4.0 and The Open Definition

 Keywords

Pythagorean Neutrosophic Refined Topology, Pythagorean Neutrosophic Refined Pre Open Set, Pythagorean Neutrosophic Refined Pre Closed Set.

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Creative Commons Attribution 4.0 and The Open Definition