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.. . , EACPT AGAH

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.. . , EACPT AGAH

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    1. ???????????? ??????? ???????????????? ? ???????????? ??????????????  ?.?. ??????????? ???. ???????? ??????????? ???????????? ????, ?????????  ??????? ??????????? ?????????? ?????????? ???????????? ?????? ???? EACPT ? AGAH

    2. ??????? ????????? ???????????? ????? ???????? ???????? • ????? ????????? ????? ? ?????? ???????? ???????? ???????????? ????????, ???? ?????? ?????: ??? ??????, ??? ??????, ????? ??????, ? ??????? – ????? •

    3. ????????? ? ???? ?? ?????? ???????????, ??????? ????? ?????? ???????? ???????? ?????????? ? ??????????? ??? ??????????, ? ? ????? ? ???? ?????? ???? ???????? ??????? ???????? ? ?????? ?????? ? ? ??????????? ?????????? •  

    4. ??????????? ???????????????? ????? ??????? ?????????? ????????????? ??????????  • ???????????? ???? ?????, ??????? ????? ?????????, ??????, ? ?????? ???????, ???????? ?? ????????? ????????   • ?????? ????? ?????????? ????????, ??? ?????????? ????????????? (????????????) ????????? ?? ??????????????? (????????????) ????????????? ???????

    5. ???????????? ????????????? ???????? — ??? ????????, ??????? ???????? ?????????????? ?????????????? ????????-???????????? ??? ????????-????????? ?????? ???????? ?? ??? ???????  • ?? ????????? ????? ???????? ??????? ??????? ?????? ???????????????? ???????? ?? ?????? ????????????? ??? ???????????? ????? ?????????????????? ???????? ???????? ? ????? ???????????? ??? ?????????????? ?????

    6. ??????? ????????????? ????????? ?????????? ? ??????? ?????????? ????????, ???????????? ? ????????????? ????????????? (???????????, ??????????????, ????????????, ?????????????? ???????????????????? ???????) ? ??????????? ???????????? ??????????? ?? ????????????? ? ???????????? ?? ?????? ? ??????? ?????????, ??????? ?????????? ? ????????? ? ??????? ??? ? ????????? ?????????? ?? ???? ??????? ????? ??????????? ?????????

    7. ??? ???????? ????????????? ????????? ????????? ??????????? ?????? Good Clinical Practice (????????? ??????????? ????????), ??? ??????? ???????? ?????????? ?????? • ???????????? ???????? ???????? ????????, ???? ???????? ???????? ? ?????? ?????? 10 ??? • ?? ???? ?????? ??????? ????????????? ????????? ?????? ??????? ??????? ?? ??? ???????? ? ???????? ??????? ??? ??????? ?????????? ???????? ? ??????? ??????????? ????????????

    8. ????????? ????????????? ?????????   • ??? ?????????????? ??????????? ?? ????? ?? ????????? ????? ???????? ???????   • ????????? ????? ???????? ????????? ????   • ????????? ????????? •

    9. ??????? — ??? ????????????? ????????, ??????? ?????????? ????? ????????? ????? ???????? ????????? ?????? ????????????? ?????????, ? ?? (?????? ???????? ????????), ????? ???????, ??? ?? ???????? ?????????????? ?????????????? ???????????????? ????????, ??????? ??? ??????????? ??? ??????? ?????? ????????? ?? ??? ?????????? ?? ???? ????????? ??????? ????? ????????????? ?????? ???????????????? ?????????, ?? ??? ??? ???? ???????????? ?????????

    10. ??????? ??????? ?? ????????????? ?????????, ??????? ???????????? ?? ?????? ????? ?? ?????? ??? ????????????? ????????? ??????? ?????????? ???????, ? ?????? — ???????? ???????????? ????????????? ??????? (Policy Relating to Generic Medicines in the OECD. Final report for the European Commission. NERA, S.J. Berwin & Co, YRCR Ltd., December, 1998) ???????? ????????? ???????????? ?????????, ???? ???????? ????????? ???? ??????? ?????, ? ?? ????? ??? ????? – ??? ?????????, ????????? ?????? ??????? ? ?????? ?????? ?????????? ?? ??????????

    11. ???????? ???????? ??????? ????? ??????? ???????, ??? ???????? ????????????? ????????? • ? ?????? ??? ??????????? ???????? ?????????? ?????????????? ??????????? ??????????, ???????? ? ???????????????? ????????? ????????? (????????????? ????????, ????????? ?? ???????????? ? ?.?.), ? ????? ?????? ? ?????????????????? • ????????? ???? ???????????? ?? ????? ??????

    12. ??? ???????, ??????? ????????? ?????????? 24 ???????? ???????????? ? ???????????? ???????????? ????????? ???????? ? ????? • ?????? ?????????? ?????????????????? ?? ?????? ???????? ?? ??????? 80 – 125% ?? ?????? ????????????? ????????? • ???????????????? ??????? ??? ?????????? «????????????? ?????????» ????????? ? ??????? 5 ???? • ????? ?????????? ???? ???????????? ??????? ????? ? ???????????

    13. ????? ???????, ???????????? ????????? ????? ?????????? ?? ????? ??????????????????? ??? ??????????????????? ????????? ?? ???????????? ?????????? • ???????? ?????? ???????????? ?????????? ?? ????????? • ???????? ????? ???? ??????????? ????????, ?.?. ?????????????????? ???????? ?????, ??? ????????? ?????? ????? ?? ????????????? ???????????? ?????????? ?? ???????????? ????????, ???????????? ?????????? ???????

    14. ?????? ????????? ????????????? ????????? ???????????? ???????? ????????? ??????? ? ??? (??? ????? ? ???????? ?????????????? ?????????????? ? ?????? ????????????? ??????????? ?????????) ????????? ????????? ??????????? ????????-??????????? ?? ?????? ????? ????????? ???????????? ??????????

    15. ???????? ?????? ???????? ???????? ???????? ???? ?????????????????? ? ??????????? ????? - ?????????????

    16. ?????????????????? ??? ????????????? ????????? ???????????????, ???? ??? ??????????????? ???????????? ? ???? ?? ?????????????? (???????? ? ??????? ??????????) ????? ???????? ? ?????????? ???????? ???? ?????? ? ????? ???????, ??? ?? ????????????? ? ???????????? ? ???????? ?????????. EMEA, The rules governing medicinal products in the European Union. Investigation of Bioavailability and Bioequivalence, v. 3C, 1998, pp. 231–244 ???????????????? ????????????? ????????? — ??? ??????????????? ????????????? ?????????, ??????? ????? ????????? ?????????????? ??? ???????????? ? ??????? ????????????????? ????????. FDA, Electronic Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations, 20th Edition, 2000

    17. ??????????????? ??????????????? ????????????? ???????? ?????????????? ???????????? ??????? ?????????, ???? ?? ???????? ?? ?? ???????? ?????????? ?, ?? ??????????? ??????????? ????????????, ???????? ????? ?? ?????????????? ? ?????????????, ??? ? ???????? ?????????, ??? ????????????? ? ???????????? ??? ???????????. The rules governing medicinal products in the European Union. Investigation of Bioavailability and Bioequivalence, v. 3C, 1998, pp. 231–244 ?????????????? ?????????????? ????????????? ????????? ????? ????????? ?????? ? ??? ??????, ???? ??? ??????????????? ????????????, ????? ?????????? ??????????? ?????? ? ?????????? ??????? ????????????. FDA, Electronic Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations, 20th Edition, 2000

    18. ? 70-? ???? ??? ????? ? ???????? ???????? ???????? ?? ??????? (????????????) ??????, ? ????? ????????????? ?????????? ?????? ???????? ?????? ? ?????????? ???????? «????????» (generics), ???????? ?? ???? ???? • ?????????? ???????? ? ??? ?????????? «??????????? ?????????», ????? ????????????? ??????? ??????????? ??????????????? ??????? ??????? ???????? ?????????? ??? ???????? ?????? ????????, ??????? ?????????? ????? ??????? ????????????? ?????, ??? ???????????? ????????

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