FDA仿制药外形和物理特性指南.pdfVIP

Contains Nonbinding Recommendations 1 Size, Shapeand, Other Physical Attributes of Generic 2 Tablets and Capsules 3 Guidance for Industry 1 4 5 6 7 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 8 this topic. It does not create any rights for any person and is not binding on FDA or the public. You can 9 use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To 10 discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title 11 page. 12 13 14 15 16 I. INTRO DUCTIO N 17 18 Tablets and capsules are widely manufactured and prescribed and may provide a number of 19 advantages over other dosage forms, including easeof storage, portability,ease of 20 administration, and accuracy in dosing. 21 22 While generic formulations of these drug products are required to be both pharmaceutically and 23 therapeuticallyequivalentto a reference listed drug(RLD),2 we are concerned that differences in 24 physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient 25 compliance and acceptability of medication regimens or could lead to medication errors. We 26 believe these patient safety concerns are important, and we are recommending that generic drug 27 manufacturers consider physical attributes when they develop quality target product profiles 28 (QTPPs) for their generic product candidates. 29 30 The recommendations in this guidanceapply to abbreviated new drug applications (ANDAs) and 31 their supplements for additional strengths that are submitted to the Office of Generic Drugs 32 (OGD). 33 34 This guidance does not apply to approve