This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic.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 it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs.
本指导草案一旦最终确定，将代表美国食品药品监督管理局（FDA，或称本机构）在该主题上的最新观点。该草案不赋予任何人任何权利，且对 FDA 或公众不具约束力。如果采用的替代方法符合适用的法规和法律要求，则可以使用该方法。如需讨论替代方法，请联系仿制药办公室。

Active Ingredient: Calcium acetate
活性成分：醋酸钙
Dosage Form; Route: Tablet; oral
剂型；给药途径：片剂；口服
Recommended Studies: One study
推荐研究：一项研究

Type of study: In vitro phosphate binding
研究类型：体外磷酸盐结合
Design: The study should be conducted by incubating test ( T ) and reference ( R ) products with at least eight different phosphate concentrations for each product. The highest phosphate concentration should be selected to achieve complete phosphate precipitation (i.e., maximum phosphate binding) capacity and a meaningful phosphate binding profile. The mean phosphate binding profile for the test and reference products should be determined. The mean of the maximum phosphate binding for test and reference products (T/R binding ratio) should be compared. The binding study should be replicated for 12 units each of the T and R products.
设计：该研究应通过将测试产品（T）和参比产品（R）分别与至少八种不同浓度的磷酸盐共同孵育进行。应选择最高的磷酸盐浓度以实现完全的磷酸盐沉淀（即最大磷酸盐结合）能力和有意义的磷酸盐结合曲线。应确定测试产品和参比产品的平均磷酸盐结合曲线。应比较测试产品和参比产品的最大磷酸盐结合均值（T/R 结合比率）。该结合研究应对测试产品和参比产品各 12 个单位进行重复。
Strength: 667 mg (Eq to 169 mg calcium)
含量：667 毫克（相当于 169 毫克钙）
Subjects: Not Applicable
受试者：不适用
Additional Comments: None
附加说明：无

Analytes to measure: Free calcium and free phosphate in the supernatant should be measured using a validated analytical method.
待测分析物：应使用经过验证的分析方法测定上清液中的游离钙和游离磷酸盐。

Bioequivalence based on point estimate: $\mathrm{T}/\mathrm{R}$$\mathrm{T}/\mathrm{R}$T//R\mathrm{T} / \mathrm{R} binding ratio within $\pm 10\mathrm{\%}$$\pm 10\mathrm{\%}$+-10%\pm 10 \% ( 0.9 to 1.1)
基于点估计的生物等效性： $\mathrm{T}/\mathrm{R}$$\mathrm{T}/\mathrm{R}$T//R\mathrm{T} / \mathrm{R} 结合率在 $\pm 10\mathrm{\%}$$\pm 10\mathrm{\%}$+-10%\pm 10 \% 范围内（0.9 至 1.1）

Waiver request of in-vivo testing: Not Applicable
体内试验豁免申请：不适用

Dissolution test method and sampling times: The dissolution information for this drug product can be found on the FDA-Recommended Dissolution Methods website, available to the public at the following location: http://www.accessdata.fda.gov/scripts/cder/dissolution/. Conduct comparative dissolution testing on 12 dosage units each of all strengths of the test and reference products. Specifications will be determined upon review of the abbreviated new drug application (ANDA).
溶出试验方法及取样时间：该药品的溶出信息可在 FDA 推荐的溶出方法网站上查阅，公众可通过以下网址访问：http://www.accessdata.fda.gov/scripts/cder/dissolution/。对测试产品和参比产品所有剂量强度的 12 个剂量单位进行比较溶出试验。规格将在审查简化新药申请（ANDA）时确定。

In addition to the method above, please conduct dissolution profiles on 12 dosage units each of the test and reference products using USP Apparatus II at 50 rpm in the following dissolution media: 0.1 N HCl , pH 4.5 Acetate Buffer, and pH 6.8 Borate Buffer.
除了上述方法外，请使用 USP 装置 II 以 50 转/分钟的转速，在以下溶出介质中对测试产品和参比产品各 12 个剂量单位进行溶出曲线测试：0.1 N 盐酸、pH 4.5 醋酸盐缓冲液和 pH 6.8 硼酸盐缓冲液。