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FDA Bioavailability Studies Submitted in NDAs or INDs – General Considerations

蒋千琴 11/7/2021 浏览 260 FDA US

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Bioavailability Studies Submitted in NDAs or INDs – General Considerations[附网盘链接]是于当前发布的FDA标准，适用于US。

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Bioavailability Studies Submitted in NDAs or INDs – General Considerations[附网盘链接]
Bioavailability Studies Submitted in NDAs or INDs – General Considerations[附网盘链接](截图)

 

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标准部分原文

Draft — Not for Implementation 1 Bioavailability Studies Submitted in NDAs or INDs — General 2 Considerations 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 15 I. INTRODUCTION 16 17 This guidance provides recommendations to sponsors submitting bioavailability (BA) 18 information for drug products in investigational new drug applications (INDs), new drug 19 applications (NDAs), and NDA supplements. This guidance contains recommendations on how 20 to meet the BA requirements set forth in 21 CFR part 320 as they apply to dosage forms intended 2

21 for oral administration. The guidance is also applicable to non-orally administered drug 22 products when it is appropriate to rely on systemic exposure measures to determine the BA of a 23 drug (e.g., transdermal delivery systems and certain rectal and nasal drug products). The 24 guidance provides recommendations on conducting relative BA studies during the IND period 25 for a drug intended to be submitted for approval in an NDA and bioequivalence (BE) studies 3

26 during the postapproval period for certain changes to drug products. 27 28 This guidance does not discuss information for demonstrating BE for drug products in 29 abbreviated new drug applications (ANDAs) and ANDA supplements. In 2013, the FDA issued 30 a separate draft guidance on this topic entitled Bioequivalence Studies with Pharmacokinetic 4

31 Endpoints for Drugs Submitted Under an ANDA. Furthermore, this guidance does not provide 32 recommendations on studies conducted in support of demonstrating comparability or 33 biosimilarity for biological products licensed under section 351 of the Public Health Service Act 1

This guidance has been prepared by the Office of Clinical Pharmacology with contributions from the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

These dosage forms include tablets, capsules, solutions, suspensions, conventional (e.g., immediate-release drug products) and modified-release (e.g., extended-release, delayed-release) drug products. 3

Bioequivalence (BE) is a statutory term reflected in the Federal Food, Drug, and Cosmetic Act (FD&C Act) in section 505(j)(21 U.S.C.). For the full definition of BE, refer to 21 CFR 314.3. 4

When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Draft Guidance Temp 1

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