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- ??????? ?????: ?? ????? ??????? ??????? ??????? ???????? ??????? ?????? ????? ???????? ??? ?????? ?????????? ???? ?????? (≥??,??) ?????? ??????? ?? ??????? ??????? (?????? ≤ ? ??? ?? ???????). ??? ????? ????? ????? ??????? ???????? ?? ????? ???????? ?????????? ??????? (NEV) ?? ????? ????? ??? ?????? ?????????? ?? ?????? ???????? ?? ??????? ?????? ??????????.
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- ???? ??????? ?????? ???????: ????? ????? ??? ?????? ??????? (DMF) ??? ????? ??????? ????????? ????????? (FDA) ????? ???? ??????? ??? ?????? ??????? ????? (GMP)? ??????? ?????? ?????? ?????? ???????? ?????? ????? ??? ????? ???? ??,??.
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- ???? ??????? ?????? ??????????: ???? ????? ?? ???? ??????? ??????? ??? ???? ???? ?????????? ??????? (micronization)? ?? ?????? ?? ????? ????? ??????? ???? ????? ??–??? ????????? ?? ?????? ????????.
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- ?????? ?? ??????? ????? ??????: ????? ????? ??? ?????? ?????????? ??????? ?? ??????? ????????? ?????????? ?? ????? ICH Q5A ????? ???? ????? ?? ?????? ??? ??????? ??,?? ?? ?????? ??????? ??????.
- ?????? ???????? ???????: ???? ??????? ????????? ???????? ?? ??????? ?????? ??????? ????? ???? ?????? ????? ?????? ??????? ??????? ??????? (COD) ?? ???? ????? ????? ???? ??? ?????? ?????? ?? ??????? ??????? ?????????? ???????? ??????? ??????.
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?. ?????? ????????: ?? ??????? ?? ????? ????? ??????? ???? ?????? ???? ?? ?????? ???? ?????? ????? ??? ????? (CR5) ???? ???. ??????? ?????? ??????? ??? ????????? ???????????? ??????? ?? ??????? ?????????? ???????? ?????? ?? ???????—????? ?????? ??????? ?????? ?????? ????? ?????? ???????? ?? ?????.
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