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
  • K., Chaitanya Prasad  (3)
  • 2015-2019  (3)
Material
Publisher
Person/Organisation
Language
Years
  • 2015-2019  (3)
Year
FID
  • 1
    Online Resource
    Online Resource
    EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 2 ( 2018-02-12), p. 21-25
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 2 ( 2018-02-12), p. 21-25
    Abstract: Pharmaceutical drug development had become very costly and time consuming. There is an estimate that a drug from molecular development to marketing approvals cost $800 Millions. Drug approval process is time consuming process most companies loss their patent exclusivity before drug gets marketing approvals. To prevent innovators from monetary losses occurred in drug development and to encourage innovation US FDA and EMEA introduced exclusivities under various categories.  Within the period of drug exclusivity no application is accepted either ANDA or 505 (b) (2).
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i2.128
    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
    CONCEPT OF 505 (b) (2) APPLICATION: BENEFITS AND CHALLENGES
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 2 ( 2018-02-12), p. 16-20
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 2 ( 2018-02-12), p. 16-20
    Abstract: A 505(b) (2) application is a new drug application (NDA) delineated in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.505(b)(2) application is one that one or a lot of the investigations relied upon by the applicant for approval "were not conducted by or for the applicant and has not obtained a right of reference or use from the person by or for whom the investigations were conducted. Section 505(b) (2) was added to FFDC Act by the Drug price competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). The applicant will depend on either revealed literature or agency’s findings of an antecedent approved drug. This approval route was designed to encourage innovation and to eliminate expensive and long duplicative clinical studies.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i2.127
    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
    INDONESIAN PATENT SYSTEM: AN OVERVIEW
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 2 ( 2018-02-12), p. 26-30
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 2 ( 2018-02-12), p. 26-30
    Abstract: Intellectual property protection is a one type of protection to the innovator from their creative efforts. On November 1, 1991, the Indonesian Parliament passed Law No. 6/1989 on Patents. The new law came into effect on August 1, 1991. The patenting system in Indonesia is discussed using some recent statistics and their fees, patent exclusivity, litigation, grace period. As of 1989, there have been over 13,000 applications for temporary patent registration, 96% of which were of foreign origins. None of the applications were denied, were ever granted because no patent Law existed. In this paper discussed brief introduction about Indonesia patent system.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i2.129
    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...