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美國(guó)fda分析方法驗(yàn)證指南中英文對(duì)照(36頁(yè))-經(jīng)營(yíng)管理-wenkub.com

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【正文】 下面論述的是那些還需要更詳細(xì)地進(jìn)行論述的方面。 For drug products: A degradation pathway for the drug substance in the dosage form, 419where possible. Data demonstrating recovery from the sample matrix as illustrated by the accuracy studies. Data demonstrating that neither the freshly prepared nor the degraded placebo interferes with the quantitation of the active ingredient. ICH Q2A and Q2B address almost all of the validation parameters. Areas that should be provided in more detail are described below. 對(duì)于制劑: 原料藥在制劑中可能的降解途徑。對(duì)于其它雜質(zhì)(如無(wú)機(jī)雜質(zhì),殘留溶劑),應(yīng)當(dāng)要進(jìn)行說(shuō)明并定量分析。對(duì)于雜質(zhì)分析方法,要標(biāo)明雜質(zhì)的名稱(chēng)和位置標(biāo)識(shí)符(如,色譜中的相對(duì)保留時(shí)間 RRT)。 Legible reproductions of representative instrument output or recordings (., chromatograms) and raw data output (., integrated areas), as appropriate. Instrument output for placebo, standard, and sample should also be provided (see section ). 清晰可讀的儀器代表性輸出和記錄資料(如色譜圖)和原始資料輸出(積分面積)。 The International Conference on Harmonisation (ICH) guidance Q2A Text on Validation of Analytical Procedures (March 1995) and Q2B Validation of Analytical Procedures: Methodology (November 1996) provide remendations on validation of analytical procedures. Analytical procedures outside the scope of the ICH guidances should still be validated. ICH指導(dǎo)原則 Q2A:分析方法驗(yàn)證( 1995年 3月)和 Q2B:分析方法驗(yàn)證:方法學(xué)( 1996年11 月)給出了分析方法驗(yàn)證的建議。 The above reporting information may not be strictly applicable to all products (., biological, biotechnological, botanical, radiopharmaceutical drugs), but any significant process and productrelated impurities should be determined and reported. 并不是所有產(chǎn)品(比如,生物制劑、生物工藝制劑、植物制劑、放射制劑)的報(bào)告都必須嚴(yán)格按照以上談到的內(nèi)容來(lái)寫(xiě),但是所有關(guān)鍵的工序以及產(chǎn)品相關(guān)的雜質(zhì)都要有檢測(cè)和報(bào)告??傆袡C(jī)雜質(zhì)是指所有達(dá)到或超過(guò)其自身定量限度的雜質(zhì)的總量。 of Results 1. General The format used to report results (., percent label claim, weight/weight, weight/volume, parts per million (ppm)) including the specific number of significant figures to be reported should be provided. 1. 通則 應(yīng)該規(guī)定關(guān)鍵計(jì)算步驟中的數(shù)字單位(例如, ‘ 標(biāo)簽 ’ 標(biāo)示量的百分比, W/W, W/L, ppm等) 2. Impurities Analytical Procedures The name and location/identifier (., retention time (RT), relative retention time (RRT)) of impurities and the type of impurity (., process, degradant, excipient degradant) should be included in the analytical procedures for impurities in the drug substance and drug product. The detection limit (DL) or quantitation limit (QL) should be stated, as appropriate. The DL or QL can be set using the drug substance39。需標(biāo)明不常見(jiàn)的危險(xiǎn)。比如說(shuō),滴定法一般來(lái)說(shuō)需要進(jìn)行空白實(shí)驗(yàn)。 All chromatographic analytical procedures should include system suitability testing and criteria. Parameters typically used in system suitability evaluations are defined and discussed in the CDER reviewer guidance on Validation of Chromatographic Methods (November 1994). 所有的色譜分析方法都應(yīng)當(dāng)要有系統(tǒng)適應(yīng)性實(shí)驗(yàn)及相應(yīng)的合格標(biāo)準(zhǔn)。對(duì)于不穩(wěn)定的或有潛在危險(xiǎn)的試劑,應(yīng)標(biāo)明其儲(chǔ)存條件,安全使用說(shuō)明和使用周期。 C. Equipment and Equipment Parameters A listing of all equipment (., instrument type, detector, column type, dimensions) should be included, as well as a list of equipment parameters (., flow rate, temperatures, run time, wavelength settings). A drawing representing the experimental configuration (., illustrating positions for a spray pattern analytical procedure) should be provided, when appropriate. C. 儀器和儀器參數(shù) 需要敘述的有:儀器列表(比如,儀器類(lèi)型,檢測(cè)器,柱子類(lèi)型,尺寸等)和儀器參數(shù)(比如,流速,溫度,運(yùn)行時(shí)間和設(shè)定波長(zhǎng)等)。 If the analytical procedure used is in the current revision of the USP/NF or other FDA recognized standard references (., AOAC International Book Of Methods) and the referenced analytical procedure is not modified, a statement indicating the analytical procedure and reference may be provided rather than a description of the method (21 CFR ). 如果所用的分析方法是 USP/NF或其它 FDA認(rèn)可參考文獻(xiàn)(如, AOAC國(guó)際方法匯編 )中且所參考的分析方法未經(jīng)過(guò)修改的話(huà),則需提供該分析方法的參引,而不用提供該分析方法的描述( 21 CFR )。 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 階段研究所需提交的分析方法和方法驗(yàn)證資料方面的指南,發(fā)起人將可以參考FDA的指南 :藥 品(包括結(jié)構(gòu)確定的,有療效的,生物技術(shù)產(chǎn)品)第 1階段研究的 IND申請(qǐng)的 CMC內(nèi)容和格式(草案, 1999年 4月)。如果這些檢測(cè)需用于某些標(biāo)準(zhǔn)品的界定,生物和免疫化學(xué)檢測(cè)的分析方法驗(yàn)證方面的特殊建議并不在本指南的范圍之內(nèi)。 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. 物理化學(xué)性質(zhì)包 括異構(gòu)體,電泳和液相色譜行為及光譜性質(zhì)等。 適當(dāng)?shù)奈锢沓?shù),比如說(shuō)熔程,沸程,折射率,離解常數(shù) (pK值 )和旋光度。 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. 適當(dāng)?shù)幕瘜W(xué)性質(zhì)資料,比如結(jié)構(gòu)式,經(jīng)驗(yàn)式和分子量等。應(yīng)當(dāng)要敘述制備標(biāo)準(zhǔn)品時(shí)所用的補(bǔ)充精制過(guò)程。非官方對(duì)照品要有盡 可能高的純度,并進(jìn)行充分地界定以確保其結(jié)構(gòu),劑量,質(zhì)量,純度和效力。 B. Certificate of Analysis A certificate of analysis (COA) for reference standards from nonofficial sources should be submitted in the section of the application on analytical procedures and controls. For standards from official sources, the user should ensure the suitability of the reference standard. The standard should be stored correctly and used within the established use interval. B.分析報(bào)告單 對(duì)于非官方標(biāo)準(zhǔn)品,在申請(qǐng)的分析方法和控制章節(jié) 中應(yīng)當(dāng)要提供該標(biāo)準(zhǔn)品的分析報(bào)
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