cong . hoa cao ket qua tu dan… · 4 quy trinh cong nghe san xu~t thuoc vien indaparnid x x x...
TRANSCRIPT
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
9 DSCKI. Bach H6ng Diroc sl chuyen Cong ty CP Duoc-khoaI TTBYT Binh Dinh
10 DSCKI. Nguyen Ngoc Dung Duoc sl chuyen Cong ty CP Duoc-khoaI TTBYT Binh Dinh
2
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
d6i chi@u PLENDIL ® Smg (Vien tac dung keo daiFelodipin Smg) san xu~t boi AstraZeneca, Thuy Di@n
2 Bao cao k@tqua danh gia nrong duong sinh hoc so voiI x x x
thu6c d6i chi@uPLENDIL ® Smg (Vien tac dung keo daiFelodipin Smg) san xuat boi AstraZeneca, Thuy Di@n
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
2 Quy . tri?h cong ngh~ 2022 Cong ty CPsan xuat thu6c ." Duoc- TTBYTvienFelodipin 5mg
.,. Binh Dinhgiaiph6ng keo dai, qui mo (Bidiphar)100.000 vien/me
12 D nh h'" kh,
("d k':" , d hh
1.3.Danh muc san pham khoa hoc dfi duoc irng dung (neu co):
s6 Ten san pham Thiri gian irng Ten CO' quan irng Ghi chuTT dung dung1
2
...
2. V~ nhfrng dong gop mrri ella nhiern vu:
- Thu6c giai ph6ng keo dai giup benh nhan giarn hrong thuoc dung, tang S1,1' tuan
thu chS d9 diSu trio
- Tuong duong sinh hoc voi thu6c phat minh.
- Cong nghe bao chS h~ phan tan r~n (vien bao phim GPKD Felodipin 5mg).
- Cong nghe t';10khung maxtrix; san pham ap dung d~u tien a Bidiphar va a Viet
Nam.
3. V~ hi~u qua ella nhiem vu:
3.1. Hieu qua kinh tS
- Giup doanh nghiep phat tri~n bSn vfmg.
- Tang doanh thu cua doanh nghi~p.
- TC;lOcong an vi~c lam cho nhiSu lao dQng.
- Tang cuemg uy tin cua cong ty tren thi trucmg.
- Giam chi phi diSu tri cho nguoi b~nh:
5
')
+ Vien nen bao phim GPKD Indapamid 1,5mg
{- Gia ban du kien 2.200 d6ng/vien, gia trung th§.u cua san pham nhap khau:
3.421 d6ng/vien
{- Nhu c§.usir dung trong ca nuoc: khoang 7.000.000 vien/nam
{- San hrong du kiSn cua Bidiphar: 1.000.000 vien/nam
{- TiSt kiem chi phi di@utri khoang 1,2 ty d6ng /nam.
+Vien nen bao phim GPKD Felodipin 5mg
<> Gia ban du kien 935 dong/vien, gia trung thau cua san pham nhap khau:
7.047 d6ng/vien
{- Nhu c§.usir dung trong ca nuoc: khoang 27.000.000 vien/nam
{- San hrong du kien cua Bidiphar: 3.000.000 vien/nam
{- TiSt kiem chi phi di@utri > 18 ty/nam.
3.2. Hieu qua xa hQi
- Giam chi phi diSu tri cho benh nhan d~c biet voi benh man tinh
- Giai quyet viec him cho nguoi lao dQng.
- Dap trng kip thai nhu c§.usir dung, chu dong nguon thu6c chua b~nh.
- Gop ph§.nph\lc V\lsuc khoe nhan dan.
- Gop ph§.nphM tri@nnganh dugc Vi~t Nam.
III. T\f danh gia, x~p lo~i k~t qua th\fC hi~n nhi~m vI}
1. V@tiSn dQth\l'c hi~n: (dimh dJu Y vao 0 tuang ung):
- N(Jph6 sa dung hgn
- N(Jp ch¢m tir tren 30 ngay d~n 06 thimg
- N(Jph6 sa ch¢m tren 06 thang
2. V@kSt qua th\l'c hi~n nhi~m V\l:
oDD
- XuJt sac DoD- Khongdgt
Giai thich ly do:
6
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)
ThS. Ph~m Thi Thanh Hurrng
7
/