M§u 1 11/2014/TT-BKHCN CONG HoA xA HOI CHi; NGHiA VIET NAM . . . DQc l~p - T\f do - H~nh phuc Binh Dinh, ngay or thang )L ndm 2020 BAo cAo KET QuA TV DANH GIA NHItM VV KHOA HQC vA CONG NGHt cAp ouoc GIA I. Thong tin chung v~ nhiem vu: 1. Ten nhiem vu: "Hoan thien quy trinh cong nghe san xu~t thu6c vien Indapamid 1,5mg va Felodipin 5mg giai phong keo dai", Ma s6: KC.I0.DA03/16-20 Thuoc chuang trinh: Nghien ciru irng dung va phat triSn cong nghe tien tien phuc vu bao v~ va cham soc sire khoe cong dong, rna s6: KC.I0/16-20. 2. Muc tieu nhiem vu: - Hoan thien duoc quy trinh cong nghe san xu~t thuoc vien Indapamid 1,5mg, Felodipin 5mg giai phong keo dai; - Danh gia duoc tuong duong sinh h9C cua thanh pham so voi thu6c d6i chiSu. 3. Chu nhiem nhiem vu: ThS. Pham Thi Thanh Huang 4. T6 chirc chu tri nhiem vu: Cong ty C6 phan Duoc- TTBYT Binh Dinh 5. T6ng kinh phi thuc hien: 21.845,00 trieu d6ng. Trong do, kinh phi tir ngan sach SNKH: 6.530,00 tri~u d6ng. Kinh phi tu ngu6n khac: 15.315,00 tri~u d6ng. 6. Thai gian th\IC hi~n thea HQ'pd6ng: B~t d~u: 06/2018 KSt thuc: OS/2020 Thai gian th\IChi~nthea van ban di~uchlnh CllaCo'quan co th~ quy~n (niu co): 30/1112020 1
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M§u 111/2014/TT-BKHCN
CONG HoA xA HOI CHi; NGHiA VIET NAM. . .DQc l~p - T\f do - H~nh phuc
Binh Dinh, ngay or thang )L ndm 2020
BAo cAo KET QuA TV DANH GIANHItM VV KHOA HQC vA CONG NGHt cAp ouoc GIA
I. Thong tin chung v~ nhiem vu:
1. Ten nhiem vu: "Hoan thien quy trinh cong nghe san xu~t thu6c vienIndapamid 1,5mg va Felodipin 5mg giai phong keo dai",
Ma s6: KC.I0.DA03/16-20
Thuoc chuang trinh: Nghien ciru irng dung va phat triSn cong nghe tien tienphuc vu bao v~ va cham soc sire khoe cong dong, rna s6: KC.I0/16-20.
2. Muc tieu nhiem vu:
- Hoan thien duoc quy trinh cong nghe san xu~t thuoc vien Indapamid 1,5mg,Felodipin 5mg giai phong keo dai;
- Danh gia duoc tuong duong sinh h9C cua thanh pham so voi thu6c d6i chiSu.
3. Chu nhiem nhiem vu: ThS. Pham Thi Thanh Huang
4. T6 chirc chu tri nhiem vu: Cong ty C6 phan Duoc- TTBYT Binh Dinh
5. T6ng kinh phi thuc hien: 21.845,00 trieu d6ng.
Trong do, kinh phi tir ngan sach SNKH: 6.530,00 tri~u d6ng.
Kinh phi tu ngu6n khac: 15.315,00 tri~u d6ng.
6. Thai gian th\IC hi~n thea HQ'pd6ng:
B~t d~u: 06/2018
KSt thuc: OS/2020Thai gian th\IChi~n thea van ban di~uchlnh CllaCo'quan co th~ quy~n (niu co):
30/1112020
1
7. Danh sach thanh vien chinh thuc hien nhiem vu neu tren g6m·
sa HQ va ten Clurc danh khoa CO'quan cong tacTT hoc, hoc vi1 ThS.Ph(;lmThi Thanh Huang
Cong ty CP Duoc-Thac si TTBYT Binh Dinh
2 TS. Nguyen Thi Thanh DuyenTruong D(;liH9C
TiSn si' Duoc Ha Noi. .3 Diroc si chuyen Cong ty CP Duoc-
DSCKI.To Thi Kim Quyen khoaI TTBYT Binh Dinh
4 ThS. Huynh ThS DuyCong ty CP Duoc-
Thac SI TTBYT Binh Dinh
5 DSCKI. Nguyen Thi Hai Ly Diroc sl chuyen Cong ty CP Diroc-khoaI TTBYT Binh Dinh
6 ThS. Tr~n Dinh KhaiCong ty CP Duoc-
Thac sl TTBYT Binh Dinh
7 DSCKI. D6 Thi Hoa Huang Duoc sl chuyen Cong ty CP Duoc-khoaI TTBYT Binh Dinh
8 DSCKI.Truang Thi My Van Ducc si chuyen Cong ty CP Duoc-khoaI TTBYT Binh Dinh
SB Ten san pharn SBIU'O'n KhBi lurrn Ch~t hronTT Xufrt f)~t Khong Xufrt f)~t Khong Xuat f)~t Khong,
sac dat sac dat sac dat1 Vien bao phim giai ph6ng keo dai Indapamid 1,5mg x x x
2 Vien bao phim giai ph6ng keo dai x x xFelodi in 5m
S" h~ d IIan p am angS6 Ten san ph§m S61U'O'ng Kh6i lU'O'ng Ch§t lU'O'n~TT Xufrt f)~t Khong Xuat f)~t Khong Xufrt f)~t Khong
sac dat sac dat sac datI Vien bao phim GPKD Indapamid 1,5mg
1 Tieu chuan co sa cua thanh pham tuong duong thu6e x x xd6i ehiSu Natrilix SR (vien, bao tac dung keo daiindapamid 1,5 mg) san xuat boi Les LaboratoiresServier Industrie - Phap
2 Bao cao kSt qua danh gia tuong duong sinh hoc so voi x x xthu6e d6i ehiSu Natrilix SR (~ien bao tac dung keo daiindapamid 1,5 mg) san xuat boi Les LaboratoiresServier Industrie - Phap
3 Bao cao kSt qua thea doi d9 6n dinh cua thanh pham x x x
3
4 Quy trinh cong nghe san xu~t thuoc vien Indaparnid x x x1.Smg giai phong keo dai, qui mo 100.000 vien/me
II Vien bao phim GPKD Felodipin Smg1 Tieu chuan co sa cua thanh pham tirong dirong thu6c x x x
3 Bao cao k@tqua theo doi dQ6n dinh cua thanh pham x x x
4 Quy trinh cong nghe san xu~t thu6c vien Felodipin Smg x x xgiai phong keo dai, qui mo 100.000 vien/me
4
.. a muc san p: am oa QC 1,1' len irng ung, C uyen glao neu co :s6 Ten san pham Thot gian d\f CO' quan d\f ki~n Ghi chuTT ki~n rrng dung rrng dung1 Quy trinh c0l!g ngh~ 2022 Cong ty CP
, ." Duoc- TTBYTsan xuat thuoc vienIndapamid 1,5mg .,. Binh Dinhgiarph6ng keo dai, qui mo (Bidiphar)100.000 vien/me
Cam doan noi dung cua Bao cao hi trung thuc; Chu nhiem va cac thanh vientham gia thuc hien nhiern V\1 khong su dung kSt qua nghien ciru cua nguoi khactrai voi quy dinh cua phap luat.
CHU NHI~M NHI~M vu(H9Cham, h9C vi, H9, ten va chit kY)