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  • 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.

  • 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.

  • ROLE OF PURPLE CORN IN TREATMENT OF TYPE 2 DIABETES AND KIDNEY DISEASE: A THERAPEUTIC REVIEW

    About Authors:
    Mr. Satyanand Tyagi
    President, Tyagi Pharmacy Association & Scientific Writer,
    Chattarpur, New Delhi, India.
    Prof. Satyanand Tyagi is a life time member of various pharmacy professional bodies like IPA, APTI and IPGA. He has published various research papers and review articles. His academic works include 50 Publications (42 Review Articles and 08 Research Articles of Pharmaceutical, Medicinal and Clinical Importance, published in standard and reputed National and International Pharmacy journals; Out of 50 publications, 11 are International Publications).
    sntyagi9@yahoo.com,
    +91-9871111375 / 9582025220

    ABSTRACT:
    Diabetic nephropathy is one of the most serious complications related to diabetes, often leading to end-stage kidney disease. Purple corn grown in Peru and Chile is a relative of blue corn, which is readily available in the U.S. The maize is rich in anthocyanins (also known as flavonoids), which are reported to have anti-diabetic properties. Scientists from the Department of Food and Nutrition and Department of Biochemistry at Hallym University in Korea investigated the cellular and molecular activity of purple corn anthocyanins (PCA) to determine whether and how it affects the development of diabetic nephropathy (DN). Their findings suggest that PCA inhibits multiple pathways involved in the development of DN, which may help in developing therapies aimed at type 2 diabetes and kidney disease. The aim of present article is to provide in depth knowledge about Purple Corn, their clinical and biological utility as well as their role in treatments of type 2 diabetes and kidney disease. An attempt is also made to focus on compounds found in purple corn which may aid in developing future treatments for type 2 Diabetes as well as kidney disease.

  • NANOTECHNOLOGY USED IN CANCER TREATMENT- A REVIEW

    About Author:
    Himani Sharma
    B.Pharm, RGTU
    shimani53@gmail.com

    ABSTRACT
    Nanotechnology provide innovative tools that shed greater light on life cycle of normal cells and the point at which molecular processes and changes within cells become correlated with development of cancer. It should be possible to obtain large amount of information from a small source. They aid in analysis of parameters such as cellular mechanics, morphology and cytoskeleton which has been hard to achieve using conventional technology. Nano devices can detect cancer cells, identify cancer signatures and provide targeted delivery of anti cancer therapeutics and contrast agents to tumour cells. Nanotechnology is potential tool that could help detect the molecular changes and assist in focusing on preventive efforts. Nanotechnologies for medical applications have been maturing. Several therapeutic formulations entered clinical trials and are expected to have an impact on how cancer treatment is done in the future.

  • PROCEDURE TO OBTAIN PATENT IN INDIA

    About Authors:
    Arshad Hala*1, Prof. Rajesh Dholpuria1, Nilesh sovasia1
    1 Seth G. L. Bihani S. D. College Of Technical Education,
    Institute Of Pharmaceutical Sciences & Drug Research,
    Gaganpath, Sri Ganganagar, Rajasthan 335001
    *Arshad_hala@yahoo.com

    ABSTRACT:
    A patent is one of the forms of intellectual property. The object of patent law is to encourage scientific research, new technology and industrial progress. The grant of exclusive privilege to own, use or sell the method or product patented for a limited period, stimulates new inventions of commercial utility. The price of the grant of the monopoly is the disclosure of the invention at the patent office, which after the expiry of the period of monopoly, passes into public domain. An invention which must be new and useful. It must have novelty and utility. The patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonable practicable without undue delay. So true inventor required to know how to get patent in india and other countries through his self or legal representative. Without patent no one use, sell, and research on invention.This review looks into procedure to obtain patent in india.

  • CHRONOPHARMACOKINETICS: THE CIRCADIAN RHYTHM OF DRUGS AND ITS IMPLICATIONS

    About Authors:
    N Allamneni*, CH Ajay Babu, AVS Madhulatha, C Anusha, P Sowjanya, BV Komali, M Kalyani, Syed M
    *Department of Pharmaceutical Technology,
    Narasaraopeta Institute of Pharmaceutical Sciences,
    Narasaraopeta, Guntur, India.
    *yaswanthallamneni@gmail.com

    ABSTRACT
    Chronopharmacokinetics involves the study of temporal changes in drug absorption, distribution, metabolism and excretion with respect to time of administration. Drug Absorption, distribution, metabolism and elimination are influenced by many different physiological functions of the body, which may vary, with time of day. Thus, the pharmacokinetic parameters characterizing these different steps, conventionally considered to be constant in time, depend on the moment of drug administration. Chronokinetic studies have been reported for many drugs in an attempt to explain chronopharmacodynamic phenomena and demonstrate that the time of administration is a possible factor of variation in the kinetics of a drug. However, the time of day has to be regarded as an additional variable influencing the kinetics of a drug since many drugs are affected by time of administration and the activity or rest period of the human or animal.

  • SURVEY ON DIABETES AND STANDARDIZATION OF POLYHERBAL FORMULATION

    About Authors:
    1Shambhawi, *Sai Saraswathi V
    1*Pharmaceutical Chemistry Division,
    School of Advanced Sciences,
    VIT-University, Vellore-632014,
    Tamilnadu, India.
    1shambhawi06@yahoo.co.in, * v.saisaraswathi@vit.ac.in

    ABSTRACT :
    Standardization of polyherbal formulation is important to validate the quality of drugs and to ensure that the consumers are getting medication which guarantees purity, safety, potency and efficacy. The present paper reports standardization of traditional ayurvedic liquid polyherbal antidiabetic formulation (Sucrogen) and diabetes survey for retrieving the information on medication along with the lifestyle of diabetic population. Sucrogen was standardized based on ayurvedic pharmacopeia physico-chemical properties, preliminary phytochemical tests, organoleptic characters, stability studies, microbial studies, TLC, HPLC, heavy metal estimation by AAS and flame photometry to fix the quality standard of this drug. Invitro anti-diabetics activity of the drug was determined using alpha amylase Inhibitory method.These studies resulted in a set of diagnostic characters essential for its standardization. The phytochemical constituents found to be present in raw materials used for the preparation of Sucrogen possibly helps in achieving the desirable therapeutic efficacy of the ayurvedic formulation.
    OBJECTIVE
    To do a general survey on diabetes and to standardize the polyherbal formulation consumed by the population of Jharkhand for the determination of purity and quality of drug

  • Vertigo Management – Mapping prevalence and treatment. Understanding once a day preparation usage and place in therapy.

    About Authors:
    Indraneel sinha*, Mr. Sanjay sahai, Mr. Sunil jajoo, Mr. Abhijeet bhatkar
    Post graduate diploma in pharmaceutical management,
    Indian institute of health management research,
    jaipur
    *indraneel.sinha.999@gmail.com

    COMPANY PROFILE
    Sun Pharmaceuticals was set up in 1983 and the company started off with only 5 products to cure psychiatric illness.  Sun Pharma is best known worldwide as the manufacture of specialty Active Pharmaceuticals Ingredients (API) and formulations.

    However, the company is also concerned with chronic treatments such as cardiology, psychiatry, neurology, gastroenterology, diabetology and   respiratory ailments. Active Pharmaceuticals Ingredients (API) includes peptides, steroids, hormones, and anti?cancer drugs and their quality is internationally approved. Mr. Dilip S. Shanghvi is the Executive Chairman and Managing Director of Sun Pharma and Mr. Kamalesh H. Shah is the secretary.

  • INVOLVEMENT OF HEALTHCARE REGULATORY AFFAIR PROFESSIONAL IN OVERSEAS REGISTRATION PROCESS

    About Authors:
    ANUJ SINGH
    VINAYAKA MISSION’S UNIVERSITY
    Salem – 636308, Tamil Nadu
    anuj.dra@gmail.com

    ABSTRACT:-
    Healthcare Regulatory Affair Professional with their experience and strong motivation to excel in the Regulatory field has an ability to motivate & give support and strengthen to teams members, involved in process of product registration. Professional has taught a self-starter with the proven ability to prioritize and manage projects in a busy, fast-paced, multitasking environment, along with their experience in establishing relationship with the decision makers & coordinator. The Pharmaceutical industries are among the most highly regulated industries in the country. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. They are required to be well versed in the laws, regulations, guidelines and guidance of the regulatory agencies. There is a growing need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries. The present article discusses the regulatory education and its need, learning resources, courses available, syllabus contents and job opportunities in regulatory affairs.

  • Pharmaceutical Process Validation: Emplication of New FDA Guidelines

    About Author:
    Ashutosh Gupta
    B.Pharm, kanpur university
    22ashutoshgupta22@gmail.com

    Abstract
    This summary represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.

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