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Current Trends in the Requirements for Safety and Efficacy of New Drugs

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Safety and Efficacy of Radiopharmaceuticals 1987

Part of the book series: Developments in Nuclear Medicine ((DNUM,volume 14))

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Abstract

The regulatory requirements concerning drugs involve quality, efficacy and safety. These matters are dealt with in national, international and supranational rules and regulations (e.g. 1).

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References

  1. The rules governing medicaments for human use in the European Community. 111/182/87. February 1987.

    Google Scholar 

  2. Kristensen K, Norbygaard E (eds.). Safety and efficacy of radiopharmaceuticals. Martinus Nijhoff Publ. 1984.

    Google Scholar 

  3. EEC Council Directive 87/22/EEC of 22.12.86 relating to the placing on the market of high technology medicinal products particularly those derived from biotechnology.

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  4. EEC Notes to applicants for marketing authorizations on requirements for the production and quality control of me-dicinal products derived by recombinant DNA technology . Draft, January 1987

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  5. EEC Notes to applicants for marketing authorizations on the requirements for the preclinical biological safety testing of medicinal products derived from biotechnology. Draft, March 1987.

    Google Scholar 

  6. Radiopharmaceuticals. Drug Applications. Nordic guidelines. Draft, Nordic Council on Medicines, January 1987

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  7. EEC Recommended basis for the conduct of clinical trials of medicinal products in the European Community . Draft, March 1987.

    Google Scholar 

  8. Hampton JR. The end of clinical freedom. Brit med J 1983; 287: 1237–1238.

    Article  CAS  Google Scholar 

  9. Hammermaier A, Reich., Bögl W. Qualitätskontrolle von in- vivo Radiopharmaka. Institut für Strahlenhygiene, Bundes-gesundheitsamt, 1986.

    Google Scholar 

  10. Lasagna L. Clinical testing of products prepared by bio-technology. Regulatory Tox Pharmacol 1986; 6: 385–390.

    Article  CAS  Google Scholar 

  11. Clinical Trials of Drugs. Nordic guidelines. Nordic Council on Medicines Publication no. 11, 1983.

    Google Scholar 

  12. Juul P . Clinical trials of radiopharmaceuticals. In Kristensen K, Norbygaard E (eds.): Safety and efficacy of ra-diopharmaceuticals. Martinus Nijhoff Publ. 1984: 179–190

    Google Scholar 

  13. Towards an international ethic for research involving human subjects. Report of the summit bioethics conference, Ottawa, 1987 (in press).

    Google Scholar 

  14. Lasagna L. On reducing waste in foreign clinical trials and postregulation experience. Clin Pharmacol Ther 1986; 40: 269–372.

    Article  Google Scholar 

  15. Drug Applications. Nordic guidelines. Nordic Council on Medicines Publication no. 12, 1983.

    Google Scholar 

  16. Notice to applicants for marketing authorizations for proprietary medicinal products in the member states of the European Community. Ill/158/54. (Revision 1987 ).

    Google Scholar 

  17. Levine RJ . Ethics and regulation of clinical research. Urban & Schwarzenberg 1986 (2. ed.)

    Google Scholar 

  18. Walker SR & Asscher AW (eds.). Medicines and risk/benefit decisions. MTP Press Ltd. 1987.

    Google Scholar 

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© 1987 Martinus Nijhoff Publishers, Dordrecht

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Dige-Petersen, H., Juul, P. (1987). Current Trends in the Requirements for Safety and Efficacy of New Drugs. In: Kristensen, K., Nørbygaard, E. (eds) Safety and Efficacy of Radiopharmaceuticals 1987. Developments in Nuclear Medicine, vol 14. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-3375-0_22

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  • DOI: https://doi.org/10.1007/978-94-009-3375-0_22

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-8016-3

  • Online ISBN: 978-94-009-3375-0

  • eBook Packages: Springer Book Archive

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