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  • Gupta, Rajkumar  (6)
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  • Gupta, Rajkumar  (6)
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  • 1
    Online Resource
    Online Resource
    FACTS ON DRUG REGULATIONS
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 3 ( 2018-02-13), p. 43-47
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 3 ( 2018-02-13), p. 43-47
    Abstract: The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products. The main focus of drug regulations is to check that safety, quality and efficacy of the drug products over its lifecycle.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i3.140
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    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
    PIC/S: TRAINING THE REGULATORS TO REGULATE cGMP COMPLIANCE
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 3 ( 2018-02-13), p. 48-51
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 3 ( 2018-02-13), p. 48-51
    Abstract: PIC/S is an international Organization for implementing cGMP standards in its member countries. The basic objective of PIC/S is to improve and standardize cGMP compliance in member countries. Their aim is to enhance GMP intelligence via sharing of GMP inspection reports. Further it wants to reduce duplication of inspections to save the cost and time. Their regulations are directed to promote harmony in GMP standards and to train national regulatory authorities for cGMP vigilance. They requires that every nation shall empower the legislation to inspect the facilities as per definite program, to issue notices for noncompliance, to impart regular training to all concerned employees.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i3.141
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 3
    Online Resource
    Online Resource
    INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 1 ( 2018-02-11), p. 29-31
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 1 ( 2018-02-11), p. 29-31
    Abstract: ANDA constitutes an important submission for marketing authorization of generic drugs. The FDA has recently mandated an electronic submission in the form of eCTD for the same. ANDA application is quite complex with respect to patent rights and BE evaluations. The incomplete applications are often refused to file and the accepted applications some time get disqualified due to technical deficiencies at the manufacturing site. Recently FDA has rejected many ANDA applications in ASEAN region on account of data integrity.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i1.122
    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
    STEPS FOR SUCCESS IN SOURCING OF HARD GELATIN CAPSULES FOR PHARMACEUTICAL USE
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 1 ( 2018-02-11), p. 32-36
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 1 ( 2018-02-11), p. 32-36
    Abstract: The sourcing of raw Gelatin for manufacturing hard Gelatin Capsules is a very critical function. It involves a thorough quality audit of the suppliers. The most critical audit points are: source of Gelatin used, quality control and quality assurance procedures, packaging system and storage conditions. In addition to these the facility shall be checked for domestic and international quality certifications and advance quality features.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i1.123
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 5
    Online Resource
    Online Resource
    MARKETING AUTHORIZATION OF VETERINARY PRODUCTS IN THAILAND
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 4, No. 1 ( 2018-02-13), p. 21-23
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 4, No. 1 ( 2018-02-13), p. 21-23
    Abstract: The registration of veterinary drugs in Thailand is much easier than human products. The major requirement is samples and associated technical documents. The documents are checked by FDA under Drug Act BE 2510 (1967). If they are properly provided, the samples are released to Department of Medical Sciences for verifying the quality. Once the samples pass the required tests, the registration no. is allotted and a letter confirming Marketing authorization is issued. The normal time line for registration is about 18 months. The registration fees per product is 250 US dollar.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v4i1.178
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 6
    Online Resource
    Online Resource
    Interview Questions on ANDA filing
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 2 ( 2021-06-15), p. 20-25
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 2 ( 2021-06-15), p. 20-25
    Abstract: This guidance document provides prominent facts on ANDA filings in FAQ format. It covers aspects like drafting, submission, review, approval of ANDA in question answer format. It is an excellent database for those seeking appointment in large pharmaceutical companies.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v9i2.464
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2021
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
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