GLORIA

GEOMAR Library Ocean Research Information Access

X

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
Filter
  • Badjatya, J. K.  (7)
  • 1
    Online Resource
    Online Resource
    SUPAC OF IMMEDIATE-RELEASE, MODIFIED- RELEASE AND SEMI-SOLID: A REGULATORY NOTE
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 3 ( 2018-02-13), p. 52-61
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 3 ( 2018-02-13), p. 52-61
    Abstract: In today scenario, as per market demand there is definitely carry out an increment or decrease in production, this is called SUPAC. Different guidelines are provided for those different types of SUPAC in by different regulatory authority for manufacturing of product. Here SUPAC guidelines for USFDA are elaborated for production in this review article.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i3.142
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 2
    Online Resource
    Online Resource
    COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 2 ( 2018-02-12), p. 5-6
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 2 ( 2018-02-12), p. 5-6
    Abstract: Timely Product registration is a challenge in today’s scenario. Regulatory agencies are keen in assessing CTD sections like redefining starting material of Drug substance manufacturing, Pharmaceutical development, impurities in Drug substance and Drug product, Container-closure. Common deficiencies are presented in this article.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i2.125
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    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 PRAGMATIC WAY TO SUSTAIN IN GENERIC PHARMA ENVIRONMENT: PLCM THROUGH REGULATORY STRATEGIES
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 2 ( 2018-02-12), p. 31-48
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 2 ( 2018-02-12), p. 31-48
    Abstract: Most thoughtful way to sustain in this competitive highly regulated Pharma generic industry environment is depended on understanding the concept of the product life cycle management (PLCM). Fact is a very less number of Pharma professionals have been familiarized them with this fascinating strategic concept. So, it’s the time now to convey that what does this PLCM means and how to put it into work. The objective of this article is to convey the use of PLCM as a strategic concept for enhancing drug’s sustainability in market for a long time, making better business decisions, enhancing profitability and finally delivering affordable, quality embedded generic drugs to customers. Also, in this manuscript an attempt has been made to compare corresponding regulatory agencies (US, EU, Canada and India) insights and view on preference of PLCM application. By careful analysis, it’s revealed that US provides most favourable environment to employ various PLCM strategies, wherein EU is equally good, nonetheless national polices could be a barrier, Canada is difficult to comprehend due to stringent laws and limited exclusivity and as of now India has least scope for PLCM application.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i2.130
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 4
    Online Resource
    Online Resource
    SELF-MEDICATION IN RELATION TO HEALTH LOCUS OF CONTROL
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 3 ( 2018-02-13), p. 62-66
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 3 ( 2018-02-13), p. 62-66
    Abstract: Present study was conducted to examine the association of self- medication and health locus of control. It was also intended to know the health problems for which people do self – medication and the medicines which are more often bought by those who do self-medication. Initially a sample of 200 persons was selected on non-random purposive sampling basis and all the people were asked whether they do self-medication? To this 56% of the respondents answered in yes and the rest said no. These one hundred and twelve participants were then administered a specially prepared checklist for self-medication and multidimensional health locus of control scale. Data were analyzed using the descriptive statistics. Multiple regressions were also used to identify the role of health locus of control in self- medication. Results revealed that health locus of control have a significant role in predicting self- medication.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i3.143
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 5
    Online Resource
    Online Resource
    TRIPS AND INDIAN PHARMACEUTICAL INDUSTRY
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 3 ( 2018-02-11), p. 7-13
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 3 ( 2018-02-11), p. 7-13
    Abstract: The TRIPs Agreement has led to a reinforcement of the protection of intellectual property, particularly in many developing countries. From the point of view of transfer of technology, the imitation of technologies from industrialized countries and the marketing of the resulting products will now be more difficult. The MNCs are also expanding vigorously in the generic segments. They are trying to grow not only organically, but through mergers and acquisitions and strategic alliance with Indian generic companies. 90% of the Indian Pharmaceutical Industry was dominated by the Global companies that imported most of the drugs. During the early 1970s, the Indian players gradually gained prominence as a result of the Indian Patent Act, 1970 which allowed Indian companies to reverse engineer Patented Molecules and launched them in the domestic markets.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i3.114
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 6
    Online Resource
    Online Resource
    DMF FILING IN US, EUROPE AND CANADA
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 4 ( 2018-02-13), p. 9-17
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 4 ( 2018-02-13), p. 9-17
    Abstract: A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, processing and packaging of a drug meant for Human/Animal use. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or amendments and supplements to any of these.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i4.172
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 7
    Online Resource
    Online Resource
    MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 1 ( 2018-02-13), p. 88-91
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 1 ( 2018-02-13), p. 88-91
    Abstract: This article states requirement of Marketing Authorization Application to get registration of Drug Product to EEA. The procedures for application of marketing authorization are: Centralised procedure, National procedure, Mutual recognition procedure, Decentralised procedure.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i1.160
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...