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含有BCS_1类和3类药物口服固体速释剂型溶出度测试和标准限度工业指南草案_FDA工业指
Contains Nonbinding Recommendations
Draft — Not for Implementation
1 Dissolution Testing and Specification Criteria for Immediate-
2 Release SolidOral Dosage FormsContaining Biopharmaceutics
3 Classification SystemClass 1and 3 Drugs
4 Guidance for Industry 1
5
6
7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug
8 Administration (FDA or Agency) on this topic. It does not create any rights for any person andnot is
9 binding on FDA or the public. You can use an alternative approach if itsatisfies the requirements of the
10 applicable statutes and regulations.To discuss an alternative approach, contact the FDA staff responsible
11 for this guidanceaslisted on the title page.
12
13
14 I. INTRODUCTION
15
16 This guidance is developed to provide manufacturerswith recommendations rfosubmission of
17 new drug applications (NDAs), investigational new drug applications (INDs), and/or
18 abbreviated new drug applications (ANDAs), as appropriate, for immediate-release (IR) tablets
19 and capsulesthat contain highly soluble drug substances. The guidanceis intended to describe
20 when a standard release test and criteria be used in lieu of extensive method developmentmay
21 and specification-setting exercises. When final,hist guidance will supersede theguidance for
22 (August 1997)
industryon Dissolution Testing of Immediate Release Solid Oral Dosage Forms
23 for biopharmaceutics classification system (BCS) class 1and3 drug substancesin immediate-
24 release drug productsthat meet the criteria in thisguidance.2 For class 2 and 4 drug substances,
25 applicantsshould still refer to the August 1997
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