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Journal Abstract Search

316 related items for PubMed ID: 21784653

  • 1. Regulatory guideline for biosimilar products in Korea.
    Suh SK, Park Y.
    Biologicals; 2011 Sep; 39(5):336-8. PubMed ID: 21784653
    [Abstract] [Full Text] [Related]

  • 2. Concept of biosimilar products in Jordan.
    Haddadin RD.
    Biologicals; 2011 Sep; 39(5):333-5. PubMed ID: 21873079
    [Abstract] [Full Text] [Related]

  • 3. Current regulatory and scientific considerations for approving biosimilars in Iran.
    Hadavand N, Valadkhani M, Zarbakhsh A.
    Biologicals; 2011 Sep; 39(5):325-7. PubMed ID: 21873077
    [Abstract] [Full Text] [Related]

  • 4. Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010).
    Kang HN.
    Biologicals; 2011 Sep; 39(5):304-7. PubMed ID: 21880507
    [Abstract] [Full Text] [Related]

  • 5. Registration of similar biological products--Singapore's approach.
    Poh J, Tam KT.
    Biologicals; 2011 Sep; 39(5):343-5. PubMed ID: 21783381
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  • 9. Current development in regulation of similar biotherapeutic products in Brazil.
    Castanheira LG, Barbano DB, Rech N.
    Biologicals; 2011 Sep; 39(5):308-11. PubMed ID: 21868247
    [Abstract] [Full Text] [Related]

  • 10. A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products.
    Schiestl M.
    Biologicals; 2011 Sep; 39(5):297-9. PubMed ID: 21784654
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  • 11. Evaluation of similar biotherapeutic products: scientific and regulatory challenges.
    Griffiths E, Thorpe R, Wadhwa M, Sohn Y.
    Biologicals; 2011 Sep; 39(5):249. PubMed ID: 21925898
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  • 12. Quality, safety and efficacy of follow-on biologics in Japan.
    Yamaguchi T, Arato T.
    Biologicals; 2011 Sep; 39(5):328-32. PubMed ID: 21890377
    [Abstract] [Full Text] [Related]

  • 13. Biosimilars and non-innovator biotherapeutics in India: an overview of the current situation.
    Malhotra H.
    Biologicals; 2011 Sep; 39(5):321-4. PubMed ID: 21784652
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  • 14. [Pharmaceutical product quality control and good manufacturing practices].
    Hiyama Y.
    Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2010 Sep; (128):1-16. PubMed ID: 21381389
    [Abstract] [Full Text] [Related]

  • 15. Similar biological medicinal products containing recombinant human growth hormone: European regulation.
    Pavlovic M, Girardin E, Kapetanovic L, Ho K, Trouvin JH.
    Horm Res; 2008 Sep; 69(1):14-21. PubMed ID: 18059081
    [Abstract] [Full Text] [Related]

  • 16. Clinical programs in the development of similar biotherapeutic products: rationale and general principles.
    Berghout A.
    Biologicals; 2011 Sep; 39(5):293-6. PubMed ID: 21911300
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  • 19. WHO Expert Committee on Specifications for Pharmaceutical Preparations.
    World Health Organization.
    World Health Organ Tech Rep Ser; 2005 Sep; 929():1-142, backcover. PubMed ID: 16353684
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  • 20. China's perspective on similar biotherapeutic products.
    Liang C, Wang J.
    Biologicals; 2011 Sep; 39(5):312-6. PubMed ID: 21924622
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