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

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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

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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

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.. 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:

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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

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