FDA Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action

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Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action[附网盘链接]是于之前发布的FDA标准，适用于U.S。

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Draft — Not for Implementation 1 1 Guidance for Industry 2 3 Bioavailability and Bioequivalence Studies for Nasal Aerosols 4 and Nasal Sprays for Local Action 5 6 7 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current 8 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 9 bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of 10 the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA 11 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call 12 the appropriate number listed on the title page of this guidance. 13 14 15 16 I. INTRODUCTION 17 18 This guidance is intended to provide recommendations to applicants who are planning product 19 quality studies to measure bioavailability (BA) and/or establish bioequivalence (BE) in support 20 of new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for locally 21 acting drugs in nasal aerosols (metered-dose inhalers (MDIs)) and nasal sprays (metered-dose 22 spray pumps). This guidance addresses BA and BE studies of prescription corticosteroids, 23 antihistamines, anticholinergic drug products, and the over-the-counter (OTC) mast-cell 24 stabilizer cromolyn sodium. Applicability of the guidance to other classes of intranasal drugs 25 that may be developed in the future should be discussed with the appropriate CDER review 26 division. 27 2 28 This guidance does not cover studies of nasal sprays included in an applicable OTC monograph

29 or studies of (1) metered-dose products intended to deliver drug systemically via the nasal route 30 or (2) drugs in nasal nonmetered dose atomizer (squeeze) bottles that require premarket 31 approval. 32 33 The first draft of this guidance was issued in June 1999 for comment. Because of changes made 34 as a result of comments received to the docket, internal discussions, and deliberations of the 35 Advisory Committee for Pharmaceutical Science, we have decided to issue the guidance once 36 again in draft. A series of attachments are being developed and will be posted with this draft 1 This guidance has been prepared by the Oral Inhalation and Nasal Drug Products Technical Committee, Locally Acting Drug Products Steering Committee, Biopharmaceutics Coordinating Committee, with contributions from the Inhalation Drug Products Working Group, the Chemistry, Manufacturing, and Controls Coordinating Committee, in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 2 21 CFR 341. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. 1

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