Miscellaneous Articles

9 December 2012

A REVIEW ON STUDENT t-TEST

About Authors:
Ram Chandra*, Abhimanyu, Dr. Ashutosh Aggarwal
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*rcgedar@gmail.com

1. Introduction
Biostatistics is contraction of biology and statistics, sometimes referred to as biometry or biometrics, is the application of statistics to a wide range of topics in biology. The science of biostatistics encompasses the design of biological experiments, especially in medicine and agriculture; the collection, summarization, and analysis of data from those experiments; and the interpretation of, and inference from, the results. Hypothesis testing determines the validity of the assumption with a view to choose between two conflicting hypotheses about the value of a population parameter. Hypothesis testing helps to decide on the basis of a sample data, whether a hypothesis about the population is likely to be true or false. Statisticians have developed several tests of hypotheses (also known as the tests of significance) for the purpose of testing of hypotheses which can be classified as:- (a) Parametric tests or standard tests of hypotheses, and (b) Non-parametric tests or distribution-free test of hypotheses. Parametric tests usually assume certain properties of the parent population from which we draw samples. Assumptions like observations come from a normal population, sample size is large, assumptions about the population parameters like mean, variance, etc., must hold good before parametric tests can be used. But there are situations when the researcher cannot or does not want to make such assumptions. In such situations we use statistical methods for testing hypotheses which are called non-parametric tests because such tests do not depend on any assumption about the parameters of the parent population. Besides, most non-parametric tests assume only nominal or ordinal data, whereas parametric tests require measurement equivalent to at least an interval scale. (Bolton Sanford 2004, Jakel James et.al. 2001)
30 November 2012

NEW DRUG APPROVAL PROCEDURE IN INDIA

About Authors:
Jatin Patel^*, Krunal Parikh, Dhiren Shah
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.com

ABSTRACT:
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.
This article includes new drug approval process in different countries include India, Australia, European union, China etc.
New drug approval process in different countries are described in logarithmic representation.
23 November 2012

STUDIES ON THE THERAPEUTIC ROLE OF VITAMIN B12 AND FOLIC ACID AGAINST ARSENIC INDUCED HEPATIC DAMAGES AT CELLULAR AND DNA LEVEL BY REACTIVE OXYGEN SPECIES

About Authors:
Tamal maity
Institute of pharmacy ,(govt.) ,
Jalpaiguri and west bengal university of health sciences
Vidyasagar University
tamalpharma@gmail.com

Abstract:
In an attempt to develop new therapeutics, Vitamin B₁₂ & Folic acid was used to screen the effect on arsenic-induced hepatic toxicity in female rat of Wistar strain. Sub chronic exposure to sodium arsenite (0.4 ppm/100 g body weight/day via drinking water for a period of 28 days) significantly increased activities of hepatic. A notable distortion of hepatocellular histoarchitecture was prominent with a concomitant increase in DNA fragmentation following arsenic exposure. A marked elevation of in hepatic tissue was also evident from the hepatic accumulation of antioxidant enzymes such as superoxide dismutase, Catalase, Xanthine Oxidase, DNA Fragmentation & Histological views. However, co-administration of Vitamin B₁₂ & folic acid (200 µl/100 g body weight/day for a period of 28 days) was found to significantly prevent the arsenic-induced alteration of hepatic function. Moreover, the degeneration of histoarchitecture of liver found in arsenic-treated rats was protected along with partial but definite prevention against DNA fragmentation induction. Similarly, generation of reactive oxygen species and free radicals were found to be significantly less along with restored activities of antioxidant like Vitamin B₁₂& Folic acid co-administered group with comparison to arsenic alone treatment group. The present investigation offers strong evidence for the hepato-protective and antioxidative efficiencies of Vitamin B₁₂& Folic acid against oxidative stress induced by arsenic.

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19 November 2012

ESSENTIAL ELEMENTS OF PATENT

About Authors:
Jatin Patel^1*, Prof. Rajesh Kumar Dholpuria², Dhiren Shah¹
²(Professor, Head of Department of pharmacognosy),
¹Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.in

ABSTRACT
Patent Right varies from country to country. In India the law which govern patent right is "Indian Patent Act 1970". Indian Patent Act, 1970 grants exclusive right to the inventor for his invention for limited period of time. Generally 20 years time has been granted to the patent holder but in case of inventions relating to manufacturing of food or drugs or medicine it is for seven years from the date of patent. There is certain legal procedure which needs to be followed in order to register. There are several attorney helping inventor in patent registration by providing them best well informed knowledge. In India patent registration can be filed individually or jointly. In case of deceased inventor this can be done his legal representative on behalf of him. All the required documents need to be filed along with the application form. Only after verification registration certificate is provided to the applicant.
5 November 2012

PROBLEM: ENVIRONMENTAL POLLUTION AND GLOBAL WARMING IDEA TO IMPLEMENT GREENERY IN INDIA

The main problem which we are facing is the Global warming because of the polluted atmosphere. My idea can reduce the global warming and can bring back the polluted free environment

MAIN OBJECTIVE:
Converting the brown economy to green economy can be done very easily and fastly only by the Indian youth by starting an effective campaign by name “earth warriors” or some other easy feasible name so that everyone in India can understand the theme of the program easily unlike the other programs that we had earlier like great power race or carbon credit race etc., which takes time for the people to understand the theme of the campaign.
4 November 2012

CONTRACT MANUFACTURING AND THEIR AUDITING

About Authors:
Arshad Hala*, Prof. Rajesh Dholpuria, Nilesh Sovasia
¹Seth G. L. Bihani S. D. College Of Technical Education,
Institute Of Pharmaceutical Sciences & Drug Research,
Gaganpath, Sri Ganganagar, Rajasthan 335001
*Arshad_hala@yahoo.com

1. INTRODUCTION:-
1.1. Origin:-
Contract manufacturing is defined as the manufacture (or partial manufacturer) of a product to the order of one person or organization (the contract giver or customer) by another independent person or organization (contract acceptor or principle manufacturer). Manufacture in this context is identified as the act of processing or packaging a medicinal product or device to a given specification.(Shah, D.H., 2000)

Contract manufacturing should be consideration as an extension of the principal manufacturer’s operation. Consequently the principal manufacturer should require the same standards of good manufacturing practices (GMP) for a contractor’s operation as he would his own. In addition, the customer must ensure that the principle manufacturer holds the relevant legal authorizations for the work to be carried out.(Shah, D.H., 2000)

The responsibility and activities undertaken by each party need to be clearly stated in a formal agreement, separate from but additional to the legal business contract formed by the placement of an order. Commercial matters need to be appreciated as being distinct from technical matter and need to be detailed separately with due consideration for compliance with local legislation.(Shah, D.H., 2000)
31 October 2012

QUALITY MANAGEMENT OF WASTE AND SCRAP DISPOSAL

About Authors:
Sahil Jasuja¹*, Mahesh Kumar Kataria¹
1 Department of Quality Assurance,
Seth G.L. Bihani S.D. College of Technical education (Institute of Pharmaceutical Sciences & Drug Research),
Sri Ganganagar, (Raj.), India.
*sahiljasuja@rediffmail.com

ABSTRACT
Regulatory involvement and environmental concerns are causing pharmacists to take a closer look at how their organizations are managing pharmaceutical waste. Each organization should evaluate its current waste management practices in comparison with state regulatory guidelines. Organizations must then develop a comprehensive plan for full compliance through segregation of waste into the appropriate waste streams. The discovery of a variety of pharmaceuticals in surface, ground, and drinking waters around the country is raising concerns about the potentially adverse environmental consequences of these contaminants. Pharmaceutical waste is not one single waste stream, but many distinct waste streams that reflect the complexity and diversity of the chemicals that comprise pharmaceuticals. Pharmaceutical waste is potentially generated through a wide variety of activities in a health care facility, including but not limited to intravenous (IV) preparation, general compounding, spills/breakage, partially used vials, syringes, and IVs, discontinued, unused preparations, unused unit dose repacks, patients’ personal medications and outdated pharmaceuticals. The consistent increase in the use of potent pharmaceuticals, driven by both drug development and our aging population, is creating a corresponding increase in the amount of pharmaceutical waste generated.
29 October 2012

AMMENDMENTS IN PATENT ACT- 1999,2002 AND 2005- OVERVIEW AND COMPARISON

About Authors:
Krunal Parikh^1*, Mr. Maheshkumar Kataria²
(assistant professor, Department of pharmaceutics)
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Krunal_2922@yahoo.in

ABSTARCT :
The word Patent originated from the Latin Word "Patene" which means 'to open'. A patent is a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time in exchange for a public disclosure of an invention.

Under the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights, patents should be available in WTO member states for any inventions, in all fields of technology, and the term of protection available should be the minimum twenty years. Different types of patents may have varying patent terms(i.e., durations).After 1972 The Act remained in force for about 24 years without any change till December 1994. An ordinance effecting certain changes in the Act was issued on 31 st December 1994, which ceased to operate after six months. Subsequently, another ordinance was issued in 1999. This ordinance was subsequently replaced by the Patents (Amendment) Act, 1999 that was brought into force retrospectively from 1^st January, 1995. The amended Act provided for filing of applications for product patents in the areas of drugs, pharmaceuticals and agro chemicals though such patents were not allowed. However, such applications were to be examined only after 31-12-2004. Meanwhile, the applicants could be allowed Exclusive Marketing Rights (EMR) to sell or distribute these products in India, subject to full filment of certain conditions.
28 October 2012

REGISTRATION DOSSIER OF PHARMACEUTICALS

About Authors:
Apeksha Gupta
Maharshi Dayanand University,
Rohtak, India.
apekshagupta87@gmail.com

ABSTRACT
The word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. Process of reviewing and assessing the dossier of a pharmaceutical product containing its detailed data (administrative, chemistry, pre-clinical and clinical) and the permission granted by the Regulatory Agencies of a country with a view to support its marketing / approval in a country is called as the “Marketing Approval or the “Registration” “Marketing Authorization” or the “Product Licensing”.
“Registration Dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. It is more commonly called as the New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union (EU) and other countries, or simply Registration Dossier. Basically, this consists of data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyzes of finished product. Therefore, they are the vehicle in a country through which drug sponsors formally propose that the Regulatory Agencies approve a new pharmaceutical for sale and marketing.

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23 October 2012

ALCOHOL IS SAFE OR DANGEROUS, IS A BIG QUESTION MARK OR WE CAN SAY IT’S A ‘WH’ TYPE QUESTION

Alcohol means ethyl alcohol are hydroxyl derivatives of aliphatic hydrocarbons. Production of alcohol needs only a few basic ingredients., these are sugar, water, yeast and a warm atmosphere. Alcohol is prepared by the fermentation process by means fermentation of sugar.