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1、SD0 EMA.VOLUME 9A of The Rules Governing Medicinal Products in the European Union, Guidelines on Pharmacovigilance for Medicinal Products for Human Use Sept. 2008. . http:/ec.europa.eu/health/fi les/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf FDA. Guidance for Industry Addendum to E2C Clinical Safety Da
2、ta Management: Periodic Safety Update Reports for Marketed Drugs Feb. 2004. . http:/www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073105.pdf Mann RD, Andrews EB. Pharmacovigilance . 2nd ed, England: John Wiley & Sons, Ltm, 2007: 63. , E , . 0 PSURS0QU. S0 , 2010, 7
3、6: 354. 3 . 0QS5E2011-05-04. . http:/ SE0QS . PSUR?Spin. S0 , 2009, 61: 1-4. Klepper MJ. The periodic safety update report as a pharmacovigilance tool . Drug Safety, 2004, 278: 569-578. L . 0.S0 , 2009, 67: 447-448. Edwards BD, Furlan G. How to apply the human factor to periodic safety update report
4、s . Drug Safety, 2010, 3310: 815.kNg%84=Z?1TbMg?ZMbCkSaZ4kSZgJ0_Z 201203K1 SkS?8Cg%84=bWSaZ4ESka|HWaaaK#kZEb1oM kE S ms| TQ460.7+2DS CcI| 1001-8255201203-A23-10How to Develop and Validate the Dissolution Test on the Quality CriteriaXIE MufengShanghai Institute for Food and Drug Control, Shanghai 201
5、203ABSTRACT: Scientifi c and reasonable quality criteria of dissolution test can refl ect the inner quality of the oral solid preparation. How to scientifi cally and objectively develop and validate the parameters of dissolution test, such as medium, agitation rate, sampling time and determining met
6、hod are reviewed in this paper. Key Words: dissolution test; quality criteria; parameterl 2011-10-08Te 197230=VYSk1bTel 13764153662 Fax 021-50798189E-mail y8=M17!7OX08=db+BeaN7Li_ZEb+Yo pHwL1pX8Cg%84=BVC _0?#43r BEkqAk !9 QbDQIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIccSD0|WkSb1 _0u05Ev0XSgg
7、rS=ggr0B0XSE0S04uYoVvSp b0?aSH(V/b1.1 ;SVvB_0SHVIM1DS0aSE0SSag0Sa uv aS FDAwLoa_0/#1btSS0g0S&KyNypLV$_0Sb9SE0,1 2008MQco_ZEyp The Dissolution Procedure: Development and ValidationDwL-5/+Tb1.3.1 opH-pwL|V0V5x) 8k5sYF pH 1.0j8.0a 37 V PVAbVr|rA HPLCEi9i pH-wLb40vAV fBJ?BYbwLV4wL X0 pH+BNVHwL wLJMa.)s5VHwLAsKfBKpH94?Z_4QbCs pHasEf5VwLgVSb1.3.2 0pKa0pKa9Es1VYVbEVvDbdHSwL pHS5?H 5a6 HwL pKa pH pH-wL$M pHt pHwL_4?wL1(Es1iSD01.4 SVI USP33-NF28 c0Z JPA%3 . kSb_HwL?SZ4aSb8/b1.4.1 4d4n50Kr 85
