美国fda分析方法验证指南中英文对照(36页)-经营管理(编辑修改稿)

美国fda分析方法验证指南中英文对照(36页)-经营管理(编辑修改稿)内容摘要：

准品是不需要进一步界定的。 非官方对照品要有尽 可能高的纯度，并进行充分地界定以确保其结构，剂量，质量，纯度和效力。 The qualitative and quantitative analytical procedures used to characterize a reference standard are expected to be different from, and more extensive than, those used to control the identity, strength, quality, purity, and potency of the drug substance or the drug product. Analytical procedures used to Draft — Not for Implementation characterize a reference standard should not rely solely on parison testing to a previously designated reference standard. 用于界定标准品的定性和定量分析 方法应当要不同于用于控制原料药或制剂的结构，剂量，质量，纯度和效力的分析方法，要比它们更深入。 用于标准品界定的分析方法不应仅仅是和先前的指定标准品进行比较实验。 Generally, this characterization information should include: A brief description of the manufacture of the reference standard, if the manufacturing process differs from that of the drug substance. Any additional purification procedures used in the preparation of the reference standard should be described. 一般来说，界定资料应当要包括： 标准品的简单工艺描述，如果其生产工艺是否于其相应的原料药的话。 应当要叙述制备标准品时所用的补充精制过程。 Legible reproductions of the relevant spectra, chromatograms, thinlayer chromatogram (TLC) photographs or reproductions, and other appropriate instrumental recordings. Data establishing purity. The data should be obtained by using appropriate tests, such as TLC, gas chromatography (GC), highpressure liquid chromatography (HPLC), phase solubility analysis, appropriate thermometric analytical procedures, and others as necessary. 相关光谱图，色谱图， TLC照片及其它仪器输出的清晰复印件。 建立纯度的资料。 应当要应用适当的检测方法来获得这些资料，比如说 TLC， GC， HPLC，相溶解分析，适当的热分析方法及其它必要的分析方法。 Appropriate chemical attribute information, such as structural formula, empirical formula, and molecular weight. Information to substantiate the proof of structure should include appropriate analytical tests, such as elemental analysis, infrared spectrophotometry (IR), ultraviolet spectrophotometry (UV), nuclear magic resonance spectroscopy (NMR), and mass spectrometry (MS), as well as applicable functional group analysis. Detailed interpretation of the test data in support of the claimed structure should be provided. 适当的化学性质资料，比如结构式，经验式和分子量等。 结构确证资料应当要包括适当的分析测试，比如元素分析， IR， UV,NMR和 MS，及适用的官能团分析。 还应当要提供具体的结构解析资料。 A physical description of the material, including its color and physical form. Appropriate physical constants such as melting range, boiling range, refractive index, dissociation constants (pK values), and optical rotation. A detailed description of the analytical procedures used to characterize the reference standard. 物理性质的描述，包括颜色和物理形态。 适当的物理常数，比如说熔程，沸程，折射率，离解常数 (pK值 )和旋光度。 用于界定标准品的分析程序的详细叙述。 For biotechnological/biological product reference standards, the remendations on characterization information above may apply and should be considered. However, additional and/or different tests would be important to assess physicochemical characteristics, structural characteristics, biological activity, and/or immunochemical activity. 至于生物技术 /生物产品的标准品，应当要考虑上述建议，可能可以应用。 然而，其它确定物理化学性质，结构特性，生物活性和 /或免疫化学活性的补充检测和 /或其它检测将是非常重要的。 Physicochemical determinations may include isoform, electrophoretic, and liquid chromatographic patterns, as well as spectroscopic profiles. Structural characterization may include a determination of amino acid sequence, amino acid position, peptide map, and carbohydrate structure. Biological and/or immunochemical activity should be assessed using the same analytical procedures used to determine product potency. 物理化学性质包 括异构体，电泳和液相色谱行为及光谱性质等。 结构界定可能包括氨基酸序列，氨基酸组成，缩氨酸图和碳水结构。 确定生物和 /或免疫化学活性的分析方法应当要和用来确定产品效力的分析方法一样。 These can include animalbased, cell culturebased, biochemical, or ligand/receptorbinding assays. While these tests may be needed for plete characterization of certain reference standards, specific remendations for validation of biological and immunochemical tests are not contained in this guidance document. 这些分析方法可以包括基于动物的，细胞培养的，生物化学的或配位体 /接受体螯合的分析方法。 如果这些检测需用于某些标准品的界定，生物和免疫化学检测的分析方法验证方面的特殊建议并不在本指南的范围之内。 V. METHODS VALIDATION FOR INDs For an investigational new drug, sufficient information is required in each phase of an investigation to ensure proper identification, quality, purity, strength, and/or potency. The amount of information on analytical procedures and methods validation necessary will vary with the phase of the investigation (21 CFR (a)(7)). V． IND中的分析方法验证 对于 IND而言，每个阶段的研究都需要有足够的资料以确保合适的认定，质量，纯度，剂量和 /或效力。 所需的分析方法和方法验证方面的资料会随着研究的阶段变化而变化 (21 CFR (a)(7))。 For general guidance on analytical procedures and methods validation information to be submitted for phase 1 studies, sponsors should refer to the FDA guidance for industry on Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well Characterized, Therapeutic, BiotechnologyDerived Products (November 1995). 关于在第 1阶段研究所需提交的分析方法和方法验证资料方面的指南，发 起人可以参考 FDA的指南 ：药品（包括结构确定的，有疗效的，生物技术产品）第 1阶段研究的 IND申请的内容和格式（ 1995年 11 月）。 General guidance regarding analytical procedures and methods validation information to be submitted for phase 2 or phase 3 studies will be provided in the FDA guidance for industry INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic BiotechnologyDerived Products, Chemistry, Manufacturing, and Controls Content and Format, when finalized (draft guidance published April 1999). 第 2 和第 3 阶段研究所需提交的分析方法和方法验证资料方面的指南，发起人将可以参考FDA的指南 ：药 品（包括结构确定的，有疗效的，生物技术产品）第 1阶段研究的 IND申请的 CMC内容和格式（草案， 1999年 4月）。 All analytical procedures should be fully developed and validation pleted when the NDA, ANDA, BLA, or PLA is submitted. 在递交 NDA， ANDA， BLA或 PLA时，所有的分析方法都应当要开发出来，并得到验证。 VI. CONTENT AND FORMAT OF ANALYTICAL PROCEDURES FOR NDAs, 230ANDAs, BLAs, AND PLAs Any analytical procedure submitted in an NDA, ANDA, BLA, or PLA should be described in sufficient detail to allow a petent analyst to reproduce the necessary conditions and o。