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Journal of Pharmaceutical Research

Article

Similar Biologics: Regulatory Prospective in India
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Journal of Pharmaceutical Research

Year: 2017, Volume: 16, Issue: 3, Pages: 191-198

Original Article

Similar Biologics: Regulatory Prospective in India

Abstract

No Abstract.

References

  • Drugs and Cosmetics Act, 1940 and Rules there under, 1945.
  • Guidelines in Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2016.
  • Guidelines in Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012.
  • WHO TRS guidelines 2012.
  • ICH and EMEA guidelines
  • IP 2014 and NIB �PAC guidance document

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