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  • Kumar, Pramod T.M.  (3)
  • Venkatesh, M P  (3)
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  • 1
    Online Resource
    Online Resource
    ACTD: BRIDGE BETWEEN REGULATORY REQUIREMENTS OF DEVELOPED AND DEVELOPING COUNTRIES
    Society of Pharmaceutical Tecnocrats ; 2013
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 4 ( 2013-12-06), p. 1-11
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 4 ( 2013-12-06), p. 1-11
    Abstract: Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review andultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provide asafe, effective and low cost which benefits the society. Filing requirements in developed countries differ fromdeveloping countries which makes the approval process tedious and time consuming for the later. To make thisprocess smooth, ASEAN CTD (ACTD) was developed by Association of South East Asian Nations (ASEAN)nations. As format of ACTD resembles the format of Common Technical Document (CTD) with some differences,hence it can be used as a step. Also if both guidelines can be harmonized then differences and variation between boththe guidelines can be minimized. This article focuses on the similarities and differences in between CTD & ACTDand highlights how ACTD can be a initiating step for developing countries to meet pharmaceutical regulations ofdeveloped countries.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i4.6
    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
    WEARABLE HEALTHCARE TECHNOLOGY – THE REGULATORY PERSPECTIVE
    Society of Pharmaceutical Tecnocrats ; 2016
    In:  International Journal of Drug Regulatory Affairs Vol. 4, No. 1 ( 2016-02-06), p. 1-5
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 4, No. 1 ( 2016-02-06), p. 1-5
    Abstract: The world today isn’t the one which it was yesterday. With the continuing evolution in technology and technologicalapplications on medical field, innovative products and services have been emerging every day. Wearable gadgetshave risen up as revolution in the medical field for patient care. A number of tech giants are pouring into thissegment; wearables have already shown an impact on various fields such as communication and navigation; butperhaps the greatest potential lies in healthcare. With this article, an attempt has been made to unlock the potential ofwearable healthcare technology and the regulatory aspects imparted on them currently. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v4i1.13
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2016
    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
    CLINICAL TRIAL IN INDIA: RISE AND FALL
    Society of Pharmaceutical Tecnocrats ; 2015
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 1 ( 2015-03-06), p. 1-13
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 1 ( 2015-03-06), p. 1-13
    Abstract: Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices throughclinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, test potentialtreatments in human volunteers to see whether they should be approved for wider use in the general population. Atreatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. India stoodas a global hub for clinical trials in past years. Later, the amendments made in Indian regulations paved for the declineof clinical trials. The aim of this article is to provide the details about the Indian clinical trial application filingprocess, the amendments made in its regulations and the challenges faced by Indian clinical trial industry. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i1.11
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2015
    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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