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FDA(+)


FDA ى+

1500



201203

2006 ى+ + ֧ࡤ FDA

2013 11 2015 5 ۧ٧ ࡤ[1]٧ࡤ[2] ࡤ (FDA) (CDER)(OGD) 2006 ى+ +[3] 9 ħ ӧ ʬ

1

1. ٦ 1.1
1 0 0 0

A







B C D







E







F







1.2



2

2 0 ICH ICH 12 12 2.5% ICH
4





1

A

1.5%

0.20%

0.5%

0.8%

1.5%

1.2% 2.0%

0.5% 1.3%

2.5%

B C D E

0.01% 0.07% 0.02% 1.0%

0.10% 0.09% 0.11% 0.30%

0.15% 0.15% 0.15% 1.0%

0.4%

1.0%

ā ā ā ā 0.4%

ā ā ā ā 0.25% 2 ā 0.08%

1.0%

F

0.50%

0.30%

0.50%





ā 0.09% 3





0.05%

0.07%

0.10%

0.07%

0.2%

0.2%



3.7%

1.4%

2.0%

1.5%

2.5%

1.4% 0.5% 2.8% 2.0%

3.5%

A 1.0% 3.5%

3

1.3

1) 0 2) 0.4% 3) 0.07% 0.02%0.03% 4) 64mg ICH 0.10% 0.15% 0.2%

1.4



1.4.1 3.7% A~F 0.6% ħ B D 0.05% 0.01%0.02% 1.4.2 BCD 0.07% 0.10% F֦ 1.4.3 BCD F 4 1.4.4 2mg/ml 0.01mg/ml 0.5% 0.02%~0.01%څ Y Z
4

5 RSD 10% ٨ B B E/0.49 A/0.70 B/0.89 C/1.44 D/1.66 F/2.55 BCD F ˧ Symtrex C185 ?m250 mm 4.6 mm

2. ٦ [4] 2.1
3

RC-1 RC-2



0 0





RC-3













2.2



5

4 USP] 0 ICH 12 12 0.1~0.2% 0.1~0.2% 0.1~0.2% 0.1~0.2%

RC-1





0.05%

0.15%

0.05%

RC-2

0.25%

0.5%

0.05%

0.25%

USP

0.2%

0.5%

USP

RC-3

0.25%

0.5%

0.10%

0.25%

USP

0.2%

0.5%

USP



0.1%

0.2%

0.05%

0.10%

ICH

0.1% 0.05~0.15% 2

0.05~0.1%

0.05~0.15%

0.2%

ICH 1



0.75%



0.30%

0.75%

USP

0.65%

0.7% 0.5~0.8%

0.3% 0.3%

1.5%

USP



-

1.5%

6

2.3

1 10~100mg ICH 0.10% 0.15% 0.2% 0.5%

2.4



2.4.1 USP 0.1% ICH 0.10% 2.4.2 0 0.15% 0.2%[5] USP 3 څ 1.5% 12 ʧ ৻ 2 ڧ 3 2 [6] Three months of accelerated stability data studies indicates that all monitored attributes of the drug product fall well within the proposed stability specifications. Comparison of accelerated (3 months) and room temperature (12 months) stability data suggests that the observed trends are overestimated by the accelerated stability studies. A tentative 2 year expiration dating period is proposed, which will The tentative 2 years

be confirmed by real-time room temperature stability data.

expiration dating period at room temperature reflects the recommended storage conditions specified in the labeling: Store at controlled room temperature, 20 -25 C (68-77F). Protect from Light. 3

3. 3.1 ICH Qualification Threshold
7

- + ʧ ICH څ 0.05% 3.2 ICH ICH 0.10% 0.2% ۨ (CDE) 0.2% 3.3 [7] (1)֧ (2)څ 3.4
5

Ӧ 5-15% I A E 3.5 (LOQ)(LOD)
6 (LOQ)(LOD)

8

Ӧħ 0.05% 0.02% ٧ࡤ 3.6 USP RC-1 RC-2 RC-1 RC-2 ٨
7

USP RC-1 RC-2 0.08%0.05%
8

3.7 ϧ
9

9

1:100 50 75%RH Z 3 RC-2 RC-3 ħҁ 3.8 The product specification includes a different dissolution medium than is used in the USP monograph USP USP 1.0-1.2 4.5 [8,9]
1 /50 pH 1.24.5 6.8

3.9

[10] FDA

֧ʬ
10



QOSէ QOS



4. 2008 ٳ 7 ˧ ֨ / i [11] 2013 5 [12] / [ ܨ 2 FDA (CDER) (OPQ) 2014 10 [13] ʦڅ ৹ Z
11

٦

5. [14] [15]


1. . ٧ۧࡤ. , 2013, 44(11), 1174-1183. 2. . ٧ࡤ. , 2015, 46(5), 538-546. 3. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandAppro ved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm120971.htm http://www.fda.gov FDA Organization Office of Medical Products and Tobacco Center for Drug Evaluation and Research CDER Offices and Divisions Office of Generic Drugs Generic Drugs: Information for Industry ANDA Forms & Submission Requirements Question based Review (QbR) for Chemistry, Manufacturing, and Controls (CMC) evaluation of an Abbreviated New Drug Application (ANDA) Question-Based Review for CMC Evaluations of ANDAs Model Quality Overall Summaries for an extended release capsule (PDF - 235KB) for an immediate release tablet (PDF - 314KB) 4. ۧ www.cde.org.cn 20030923 http://www.cde.org.cn/dzkw.do?method=largePage&id=1382 5. . ICH www.cde.org.cn 20061211 http://www.cde.org.cn/dzkw.do?method=largePage&id=311390. 6. . . 2001 1 111 .
12

7. FDA 2013 10 28 A06 http://web.yyjjb.com:8080/html/2013-10/28/content_200757.htmANDAs p RLD BE RLD 8. . . , 2012, 43(3), A23-A32. 9. . . , 2014, 45(7), 687-689. 10. . 2011 9 1 http://train.sfdaied.org/book_cd/book_cd/product.asp?ProductType=2&Keyword=&TypeNa me=&page=2. 11. ٧ http://www.cde.org.cn/reviewDe.do?method=showFAQ&id=38 12. : http://www.chp.org.cn/cms/newscenter/attachments/000113.html. 13. FDA http://www.bioon.com/trends/news/604699.shtml. 14. 2014 5 .

15. + . http://view.news.qq.com/zt2013/ydfzy/index.htm.

13


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