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  • Kumar, Pramod T.M.  (3)
  • 2015-2019  (3)
Material
Person/Organisation
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  • 2015-2019  (3)
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  • 1
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2015
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 2 ( 2015-06-06), p. 1-7
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 2 ( 2015-06-06), p. 1-7
    Abstract: In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2015
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2016
    In:  International Journal of Drug Regulatory Affairs Vol. 4, No. 1 ( 2016-02-06), p. 1-5
    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
    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 ...
  • 3
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2015
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 1 ( 2015-03-06), p. 1-13
    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
    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 ...
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