Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
March 2013
CMC
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Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
Additional copies are available from:
Office of Communications
Division of Drug Information, WO51, Room 2201
突如其来的意思Center for Drug Evaluation and Rearch
忧郁的意思Food and Drug Administration
10903 New Hampshire Ave., Silver Spring, MD 20993
Phone: 301-796-3400; Fax: 301-847-8714
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v/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
March 2013
CMC
TABLE OF CONTENTS
本年度
I.INTRODUCTION (1)
粉蒸草鱼II.BACKGROUND (1)
III.DISCUSSION (2)
A.Guidelines and Criteria (3)
B.Nomenclature and Product Labeling (5)
Guidance for Industry1
Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation This guidance reprents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can u an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
I. INTRODUCTION
This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. (A scoring feature facilitates the practice of tablet splitting.2) Specifically, this guidance recommends:
•Guidelines to follow, data to provide, and criteria to meet and detail in an application to support approval of a scored tablet.
•Nomenclature and labeling for approved scored tablets.
This guidance does not address specific finished-product relea testing, where additional requirements may apply to scored tablets. This guidance does not describe the medical practice conditions under which tablet splitting is considered or recommended.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The u of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. BACKGROUND
The Agency has previously considered tablet scoring as an issue when determining whether a generic drug product is the same as the reference listed drug (RLD).3 One characteristic of a
1 This guidance has been prepared by the Office of Pharmaceutical Science in the Center for Drug Evaluation and Rearch (CDER) at the Food and Drug Administration.
2 A score is a debosd line that runs across the planar surface of the tablet, while tablet splitting is the practice of breaking or cutting a higher-strength tablet into smaller portions.
3 See the Manual of Policies and Procedures on Scoring Configuration of Generic Drug Products (5223.2), November 1, 1995.
tablet dosage form is that it may be manufactured with a score or scores. This characteristic is uful becau the score can be ud to facilitate the splitting of the tablet into fractions when less than a full tablet is desired for a do. Although there are no standards or regulatory requirements that specifically address scoring of tablets, the Agency recognizes the need for consistent scoring between a generic product and its RLD.
Consistent scoring ensures that the patient is able to adjust the do, by splitting the tablet, in the same manner as the RLD. This enables the patient to switch between products made by different manufacturers without encountering problems related to the do. In addition, consistent scoring ensures that neither the generic product nor the RLD has an advantage in the marketplace becau one is scored and one is not.
CDER’s Drug Safety Oversight Board considered the practice of tablet splitting at its October 2009 and November 2010 meetings.4 During tho meetings, they discusd how insurance companies and doctors are increasingly recommending that patients split tablets, either to adjust the patients’ do or as a cost-saving measure. Becau of this, the Agency conducted internal rearch on tablet splitting and concluded that in some cas, there are possible safety issues, especially when tablets are not scored or evaluated for splitting. The Agency’s concerns with splitting a tablet included variations in the tablet content, weight, disintegration, or dissolution, which can affect how much drug is prent in a split tablet and available for absorption. In addition, there may be stability issues with splitting tablets.5,6描写操场的句子
Tablet splitting also is addresd in pharmacopeial standards. The European Pharmacopeia (EP) currently applies accuracy of subdivision standards for scored tablets—and has at various times also
included standards for content uniformity, weight variation, and loss of mass—while the United States Pharmacopeia (USP) published a Stimuli article in 2009 proposing criteria for loss of mass and accuracy of subdivision for split tablets.7
III. DISCUSSION
初中毕业
As an outgrowth of the discussions, we are providing recommendations for application content regarding the scientific basis for functional scoring on solid oral dosage form products to ensure the quality of both NDA and ANDA scored tablet products. To accomplish this, we have developed consistent and meaningful criteria by which scored tablets can be evaluated and labeled by (1) providing a harmonized approach to chemistry, manufacturing, and controls (CMC) reviews of scored tablets; (2) ensuring consistency in nomenclature (e.g., score versus bict) and labeling; and (3) providing information through product labeling or other means to healthcare providers.
4 Public summaries of the Drug Safety Oversight Board meetings are available at
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v/AboutFDA/CentersOffices/CDER/ucm082136.htm.
5 Na Zhao et al., 30 November 2010, 401(1-2), “Tablet Splitting: Product quality asssment of metoprolol succinate extended relea tablets,” International Journal of Pharmaceutics.
6 Rakhi Shah et. al., 26 August 2010, “Tablet Splitting of a Narrow Therapeutic Index Drug: A Ca with Levothyroxine Sodium,” AAPS PharmSciTech.
7 Geoff Green et al., November-December 2009, 35(6), “Pharmacopeial Standards for the Subdivision Characteristics of Scored Tablets,” Pharmacopeial Forum.
