FDA CVM GFI #224 (VICH GL52) Bioequivalence Blood Level Bioequivalence Study
标准简介
CVM GFI #224 (VICH GL52) Bioequivalence Blood Level Bioequivalence Study[附网盘链接]由Food&Drug Administration于不久前发布，适用于U.S。标准截图
![CVM GFI #224 (VICH GL52) Bioequivalence Blood Level Bioequivalence Study[附网盘链接]](/img/20210914103702h7iby.jpg)
标准文档说明
标准文档类型为CVM GFI #224 (VICH GL52) Bioequivalence Blood Level Bioequivalence Study[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
GUIDANCE FOR INDUSTRY BIOEQUIVALENCE: BLOOD LEVEL BIOEQUIVALENCE STUDY This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION A. OBJECTIVE: This guidance is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products. To meet this objective, the guidance addresses the following topics: • A harmonized definition of BE. • Factors/variables that should be considered when developing scientifically sound blood level BE study designs. • Information that should be included in a blood level BE study report. The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) strives to eliminate repetitious and unnecessary testing through harmonization of regulatory recommendations for the registration of veterinary products, a goal that undoubtedly leads to a reduction in the number of animals used for product development and registration. In general, FDA’s guidance documents 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 use of the word should in Agency guidances means that something is suggested or recommended, but not required. B. BACKGROUND: Within the context of this guidance, BE is defined as the absence of a difference (within predefined acceptance criteria) in the bioavailability of the active pharmaceutical ingredient (API) or its metabolite(s) at the site of action when administered at the same molar dose under similar conditions in an appropriately designed study. When using blood drug concentrations as a surrogate for demonstrating product BE, there is an underlying assumption that two products having an “equivalent” rate and extent of drug absorption, as measured in the blood, will be therapeutically indistinguishable and therefore interchangeable in a clinical setting.
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