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FDA Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)

蒋千琴 12/18/2021 浏览 399 FDA U.S

标准简介

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)[附网盘链接]是于不久前发布的FDA标准，适用于U.S。

标准截图

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)[附网盘链接]
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

1 Compliance Policy for the Quantity of Bioavailability and 2 Bioequivalence Samples Retained Under 21 CFR 320.38(c) 1

3 Guidance for Industry 4 5 6 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 7 this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can 8 use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To 9 discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title 10 page. 11 12 13 14 15 I. INTRODUCTION 16 17 This guidance describes FDA’s compliance policy related to the retention of reserve samples of 2

18 the test article and reference standard used in an in vivo bioavailability (BA) and in vivo or in 19 vitro bioequivalence (BE) study. Specifically, this guidance: 20 21 • Addresses the requirement at 21 CFR 320.38(c) to retain reserve samples of sufficient 22 quantity to permit FDA to perform five times all the release tests required in an 23 application or supplemental application 24 25 • Describes the conditions under which the Agency does not generally intend to take 26 enforcement action against an applicant or contract research organization (CRO) for 27 retaining less than the quantity of reserve samples of the test article and reference 28 standard that were used in the BA or BE study as specified in 21 CFR 320.38(c). 29 30 This guidance applies only to the requirements for retention of reserve samples contained in 21 31 CFR 320.38(c). This guidance does not apply to the other requirements for retention of reserve 32 samples contained in 21 CFR 320.38, such as how testing facilities must select samples for 33 testing, how the reserve samples must be retained, and whether reserve samples are in fact 34 representative of the test article and reference standard used in the BA or BE study. Additionally, 35 this guidance does not apply to the requirement in 21 CFR 211.170 to retain samples under 36 current good manufacturing practices. 37 38 1

This guidance has been prepared by the Office of Generic Drugs, Office of Compliance, and Office of Translational Sciences in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

A reference standard is the drug product selected by FDA that an applicant seeking approval of an abbreviated new drug application must use in conducting an in vivo bioequivalence study required for approval. 21 CFR 314.3(b).

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