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  • Badjatya, Jitendra Kumar  (3)
  • 2010-2014  (3)
Material
Publisher
Person/Organisation
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  • 2010-2014  (3)
Year
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  • 1
    Online Resource
    Online Resource
    OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION
    Society of Pharmaceutical Tecnocrats ; 2013
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 1 ( 2013-02-05), p. 1-4
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 1 ( 2013-02-05), p. 1-4
    Abstract: Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrumcovering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulatedindustries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceuticalindustries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized variousindustries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a veryspecific meaning within the pharmaceutical industries.DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionalsare dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples.RA as profession is broader than registration of products, they advise companies both strategically and technically at thehighest level. Their role begins right from development of a product to making, marketing and post marketing.Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientificthinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are alsoplaced upon the claims which can be made for the product on labeling or in advertising.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i1.1
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2013
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES
    Society of Pharmaceutical Tecnocrats ; 2013
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 3 ( 2013-10-31), p. 1-6
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 3 ( 2013-10-31), p. 1-6
    Abstract: Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i3.5
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2013
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA
    Society of Pharmaceutical Tecnocrats ; 2014
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 1 ( 2014-03-06), p. 1-11
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 1 ( 2014-03-06), p. 1-11
    Abstract: Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. 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 focuses on drug approval process in different countries like USA, Europe and India. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i1.7
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2014
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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