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首頁 > 技術文章 > EMA 角質層取樣(膠帶剝離術)深圳銳拓翻譯稿

EMA 角質層取樣(膠帶剝離術)深圳銳拓翻譯稿

更新時間:2023-03-06      點擊次數:419
 

This annex provides information for an in vivo stratum corneum sampling (or tape stripping (TS)) study for semi-solid formulations as a permeation kinetic method to show equivalence, in lieu of a therapeutic equivalence study.

本附錄提供了半固(gu)體制劑的體內角質層取樣(或(huo)膠帶剝離(TS))研究的信息,作為滲透動力學方法,以顯示等效性,而不是治療等效性研究。

The S.C. sampling study is a minimally invasive technique that involves sequential removal of the outermost skin layer (i.e., the stratum corneum (S.C.)) using adhesive tapes after application of a drug-containing formulation. The amount of drug in the S.C. depends on three main processes: drug partitioning from the formulation into the SC, drug diffusion across the S.C., and drug partitioning out of the S.C. into the viable tissues. A major advantage of TS is that the experiment is conducted in vivo with a fully functioning cutaneous microcirculation so that drug clearance from the skin is unimpeded.

S.C.取樣研究是一種微創技術,涉及在施用含藥物制劑后使用膠帶依次去除最外層皮膚(即角質層(S.C.))。S.C.中的藥物量取決于三個主要過程:藥物從制劑分配到SC中,藥物在S.C.中擴散,藥物從S.C.分配到活組織中。TS的(de)一個主(zhu)要優點是(shi),該實驗(yan)在體內進行,具有完(wan)全功能的皮膚(fu)微循環,因此藥物從皮膚的清(qing)除是不受阻礙的。

TS data provide direct measurements and information on the local bioavailability of semi-solid drug products that act on or in the S.C. e.g. antifungal products. In cases when the target sites of action are beyond the S.C., TS data may provide a suitable surrogate to characterise the rate and extent of drug absorption to the underlying tissues.

TS數據提供了作用于S.C.或在S.C.中的半固體藥物產品(例如抗真菌產品)的局部生物利用度的直接測量和信息。在目標作用位點超出S.C.的情況下,TS數據可以提供一(yi)個合適的替代物,以(yi)表(biao)征(zheng)藥物吸收(shou)到底層組織的速率(lv)和程度。

In vivo TS studies are only applicable for products where drug diffusion into and through the SC takes place. Thus, TS should not be used for testing of drug products to be applied on significantly damaged skin (e.g. open wounds, burns) or skin of premature new-born. In addition, any products that contain volatile drugs or target primarily the cutaneous appendages (e.g. hair follicles, sebaceous glands) are also not suitable.

體內TS研究僅適用于藥物擴散進入和通過SC的產品。因此,TS不應用于測試應用于重受損皮膚(fu)如開放(fang)性傷(shang)口、燒傷)或(huo)早產新生兒皮膚(fu)的藥物產品。此外,任何含(han)有揮發性藥物或主要針對皮膚附件(如毛(mao)囊(nang)、皮脂腺)的(de)產品也不適用。

A TS study is not an automated process and careful consideration of the experimental design is vital. The experimental conditions of the pivotal study should be assessed individually for the concerned products and should be established by performing a pilot TS study. A summary of the development and optimisation of the TS method should be provided.

TS研究(jiu)(jiu)不是一個自動化的過(guo)程,仔細考慮(lv)實(shi)驗(yan)設計至(zhi)關(guan)重要。關(guan)鍵(jian)研究(jiu)(jiu)的實(shi)驗(yan)條件應(ying)針對相關(guan)產品進(jin)行(xing)單(dan)獨(du)評估,并(bing)應(ying)通過(guo)進(jin)行(xing)TS試驗(yan)研究(jiu)(jiu)來(lai)確定。應(ying)提供TS方法開發和優化的總結。

The following experimental conditions should be established and verified during the pilot study:

在試點(dian)研究期間,應建立并(bing)驗證以下實驗條件(jian):

●TS study should be conducted on healthy, normal forearm (volar) skin areas with avdequate skin barrier function. The inclusion/exclusion criteria for skin conditions should be defined. Skin with tattoos, any signs of dermatological abnormality or exhibiting a significant density of terminal haivr should be excluded. The preparation and cleaning procedures prior to the experiment should be established and further, that the treatment sites are not damaged by these processes.

TS研究應在具有足夠皮膚屏障功能的健康、正常前臂(掌側)皮膚區域進行。應確定皮膚狀況的納入/排除標準。任何(he)帶(dai)有紋身(shen)、有皮膚病異常跡象或末端毛(mao)發(fa)密(mi)度(du)明顯的皮(pi)膚,應排(pai)除(chu)在外。制定實驗(yan)前的準備和清(qing)潔(jie)程序(xu),并(bing)進一步確保這些過(guo)程不會損壞處理部位。

 

●Skin integrity should be determined before and after the experiment. This is normally performed by the measurement of Transepidermal Water Loss (TEWL), although other techniques may be applicable if appropriate. The acceptance criteria should be fully discussed and justified.

應在(zai)實驗前后確(que)定皮膚完(wan)整性(xing)。這通(tong)常是通(tong)過測量(liang)經表皮失水(TEWL)來進行(xing)的,但(dan)如果合適的話,其他(ta)技術也可能適用。應充(chong)分討論并(bing)證明(ming)驗收標準的合理性(xing)。

●Due to inter-subject variability, the products to be compared should be applied on the same subject. Additionally, a negative control that is non-equivalent to the comparator product should also be included to demonstrate the discriminatory power of the method. It is recommended to blind the investigator responsible for formulation application and tape stripping to minimise risk of bias.

由于受(shou)試者(zhe)之間的差異,應(ying)(ying)將(jiang)待(dai)比較的產品應(ying)(ying)用于同(tong)一受(shou)試者(zhe)。此外,還(huan)應(ying)(ying)包括與對照(zhao)品不等(deng)(deng)同(tong)的陰性對照(zhao),以(yi)證明該方法的歧視性。建議讓負責配方應(ying)(ying)用和膠(jiao)帶剝離的研究人員盲試驗,以(yi)最大限度地減少偏倚風險(xian)。

●The dosing amount should be determined based on the SmPC. During the pilot study, the dosage and area of dose application should be verified to achieve a quantifiable mass of active substance in the SC. The dosing technique, blinding and randomisation procedures should also be established.

劑量(liang)應根據SmPC確定(ding)。在試點研究期間,應驗證劑量(liang)和劑量(liang)應用面積,以在SC中獲得可量(liang)化的活性物質質量(liang)。還(huan)應建立劑量(liang)技術、盲法和隨(sui)機化程序(xu)。

●A single dose approach should be followed, i.e. skin stripping is performed after a single application of the test and comparator products.

應采用(yong)單(dan)劑量方法,即在(zai)單(dan)次應用(yong)測(ce)試和對照產品后(hou)進行皮膚剝離。

It is necessary that the products are compared at two time points (one uptake, one clearance) for each subject. The optimal uptake and clearance times depend on the characteristics of the drugs and products and should be determined during the pilot study. Ideally and when relevant, the uptake time should be sufficiently long for the drug to have attained the diffusional steady state. This can be established by testing at multiple uptake times and from which time the mass of drug recovered from the SC remains constant. The clearance time should be long enough to allow measurable transfer of drug from the SC into the viable skin (and beyond) but should not exceed 48 hours to avoid any skin desquamation effect. The clearance time providing at least a 25% decrease in the mass of drug recovered from the SC with respect to that at the uptake phase is preferred. In all cases, the sampling times should be carefully  considered and justified.

有必要在兩個時間點(一次吸收,一次清除)對每個受試者的產品進行比較。最佳吸收和清除時間取決于藥物和產品的特性,應在試點研究期間確定。在相關的理(li)想情況下,吸收時間應足夠(gou)長,以使藥物(wu)達到擴散穩定狀態。這可以通過在多次攝取時間進行測試來確定,從該時間起,從SC中回收的藥物質量保持恒定。清除時間應足夠長,以允許可測量的藥物從SC轉移到活的皮膚中(或更久),但不應超過48小時,以避免任何皮膚脫屑影響。相對于攝取階段,從SC回收的藥物質量提供至少25%減少的清除時間是優選的。在所有情況下,應仔細考慮并證明取樣時間的合理性。

The drug product should be removed from the skin surface after the specified uptake time. The cleaning procedure should be established to ensure that the residual formulation is efficiently removed from the treatment sites before stripping.

藥物產(chan)品應在規定(ding)(ding)的攝取時間后從皮膚表面移除(chu)。應制定(ding)(ding)清潔程序,以確(que)保在剝離前有效地從處(chu)理部位去除(chu)殘留制劑。

The adhesive tape chosen should meet the following requirements: a) does not lose mass when applied and rubbed against the skin surface; b) minimal weight loss and gain during storage; c) the drug is readily extracted from the SC adhered to the tape; d) the adhesive or other components of the tape do not interfere with the analytical quantification of the drug; and e) the adhesive power should be such that the majority of the SC is removed with a sufficiently low number of tapes (e.g. not more than 30 tapes).

選擇的膠帶應滿足以下要求:a)在應用和摩擦皮膚表面時不會失去質量;b) 儲存期間的最小化重量損失和(he)增加;c) 藥物容易從粘附在膠帶上的SC中提取;d) 膠帶的粘合劑或其他成分不干擾藥物的分析定量;以及e)粘合力應使得大部分SC用足夠低數量的膠帶(例如不超過30條膠帶)去除。

The TS procedure followed must ensure that most of the SC (≥75%) is sampled for each skin site. The minimum and maximum number of tapes should be established based on the TEWL (or other relevant) criteria, e.g. eight-fold increment over baseline value, safety stop value.

遵循(xun)的TS程序必(bi)須確保對每個皮膚部(bu)位的大(da)部(bu)分SC(≥75%)進行采樣。膠帶(dai)的最(zui)小和(he)最(zui)大(da)數量(liang)應根(gen)據TEWL(或其他相(xiang)關)標準確定,例(li)如比基(ji)線值(zhi)增加8倍(bei),安全停止值(zhi)。

Most commonly, the drug is first extracted from the tapes then quantified in the extraction solvent(s). Alternative methods of extraction/quantification may be used if justified. Satisfactory efficiency should be demonstrated for the proposed extraction method.最常見的(de)是(shi),首先從膠(jiao)帶中提(ti)取藥物,然后(hou)在(zai)提(ti)取溶劑中定(ding)量。如果合理,可使用其他提(ti)取/定(ding)量方法(fa)。應證明(ming)所提(ti)出(chu)的(de)提(ti)取方法(fa)具有令人滿意的(de)效率(lv)。

Detailed standard operating procedures should be prepared for the conduct of TS studies to ensure precise control of dosing, cleaning, stripping, extraction, quantification and other study variables or potential sources of experimental bias. The inclusion/exclusion criteria should be pre-defined and clearly stated in the protocol.

在進行TS研究時,應制定詳細的標準操作程序,以確保精確控制劑量、清洗、剝離、提取(qu)、定量(liang)和其(qi)他研究變量(liang)或實驗偏(pian)差的(de)潛(qian)在來(lai)源(yuan)。納(na)入/排除標準應預先定義,并在方案中明確說明。

The following study design is recommended for TS studies. The final protocol developed for each specific case should be justified.

TS研(yan)究(jiu)建議采(cai)用以下研(yan)究(jiu)設計(ji)。應該針(zhen)對每種具(ju)體情況(kuang)制定合理的(de)最終(zhong)方案。

Subjects – TS studies should be performed in healthy volunteers. The subjects should be screened for suitability in line with the principles of bioequivalence studies.

受試(shi)者(zhe)–TS研究應在(zai)健康志愿(yuan)者(zhe)中進行(xing)。應根據生物(wu)等(deng)效(xiao)性研究的原則篩選合適的受試(shi)者(zhe)。

Treatment area –healthy skin of the volar forearm areas sufficient to accommodate at least six application sites per forearm. Skin integrity should be verified e.g. by TEWL measurement. The same number of application sites should be assigned to each forearm;

治療區域–前臂掌側區域的健康皮膚,個前臂(bei)至少有(you)六個應(ying)用部位。應(ying)通過(guo)TEWL測量(liang)進行皮膚完整性驗證。應為每個前(qian)臂分配相同數量(liang)的應用(yong)部位;

Number of subjects – the choice of the number of subjects should be justified based on the variability estimated from the pilot studies and demonstrated to be statistically relevant. A minimum of 12 subjects should be used to demonstrate equivalence;

受試者數量——受試者的數量選擇應根據(ju)試點(dian)研(yan)究估計的變(bian)異性進行證明,并證明其具有統計學意義。應使用至少12名受(shou)試者來證(zheng)明等效性(xing);

Number of replicates – at least two application sites per product (test, comparator and a negative control) per forearm. One forearm should be used for uptake samples and the other for clearance;

重復次數–每個前臂(bei)每個產品至少有兩個應用部位(測(ce)試、對照(zhao)和陰性(xing)對照(zhao))。一側(ce)前臂用(yong)于吸收樣本(ben),另一側(ce)用(yong)于清(qing)除;

The products should be applied at pre-determined doses (±5%) and spread evenly over the entire demarcated application sites. Blank samples should be collected from the adjacent areas to verify the absence of background levels of drug or other compounds that may interfere with the quantification of drug in the treated SC;

產品應(ying)以預定劑量(±5%)涂抹,并均勻(yun)分布在(zai)整個劃定的(de)涂抹部位。應(ying)從相鄰區(qu)域采集空白(bai)樣品,以驗證是否存(cun)在(zai)可能干擾治療SC中藥物定量的(de)藥物或其(qi)他化合物的(de)背景(jing)水平(ping);

The application sites should be randomised to avoid bias. The application time should be staggered to allow time for S.C. sampling;

用(yong)藥位(wei)點應(ying)隨機,以(yi)避免選(xuan)擇偏向性。應(ying)用(yong)時間(jian)應(ying)錯(cuo)開,以(yi)留出S.C.取樣時間(jian);

Un-occluded conditions, unless occlusion is recommended in the product information, or otherwise justified e.g. to prevent inadvertent removal of formulation.

非封閉條件,除(chu)非產品信息(xi)中建議封閉,或以其他方(fang)式(shi)證(zheng)明封閉是合理的(de),例如防(fang)止無意中移除(chu)制劑。

The formulation should be removed from all treatment sites (uptake and clearance) at the end of the uptake phase. The total cleaning time should be minimised to avoid any artefacts due to further drug diffusion. Skin integrity of the treated area should be checked before stripping;

在吸收階段結束時,應從所有治療部位(吸收和清除)移除制劑。應盡量縮短總清洗時(shi)間,以避(bi)免(mian)因藥物進一步(bu)擴散(san)而產生任何假陽(yang)性。剝離前(qian)應檢查處理區域的皮膚完整性(xing);

The ‘uptake’ sites should be tape-stripped immediately after formulation removal. The ‘clearance’ sites should be tape-stripped at the pre-defined clearance times;

“吸收”部(bu)位(wei)應在(zai)移除(chu)制劑后立(li)即用膠(jiao)帶剝(bo)離。“清理(li)(li)”部(bu)位(wei)應在(zai)預定義的清理(li)(li)時間進行膠(jiao)帶剝(bo)離;

The exact number of tapes required should be determined based on TEWL measurements of the stripped area and the stopping criteria established from the pilot study;

所(suo)需膠帶(dai)的(de)(de)確(que)(que)切數(shu)量(liang)應根據剝(bo)離區域的(de)(de)TEWL測(ce)量(liang)值和試點研究(jiu)確(que)(que)定(ding)的(de)(de)停止標準(zhun)確(que)(que)定(ding);

The mass of SC removed per tape should be determined using a gravimetric method by weighing the tapes strips before and after stripping. Alternative methods of quantification of the SC can be used if suitably described and justified;

每(mei)個膠帶上(shang)去除的(de)SC的(de)質量(liang)應通過(guo)在剝離(li)前后(hou)稱重(zhong)膠帶的(de)重(zhong)量(liang)來確(que)定。如果有適當描述和合理(li)理(li)由,可以使(shi)用替代性的(de)SC量(liang)化方法;

All stripped tapes collected from each treatment site should be analysed. The first two tapes should be analysed separately from the remaining tapes, so their contribution to the total amount of drug recovered can be eva1uated. To enhance analytical detectability, the subsequent tapes can be combined in groups (e.g. each group containing the required minimum content of SC) for extraction. The total mass of drug in the SC should be calculated as the sum extracted from all tape strip samples. The mass balance, including the drug content removed from the surface by cleaning should be determined for each treatment site. The overall recovery of 90-110% would be acceptable without justification; larger variation should be fully explained.

應(ying)分(fen)(fen)(fen)析(xi)從(cong)每個處理(li)部位(wei)(wei)收集的(de)所有剝離膠帶(dai)。為評(ping)估它(ta)們對回(hui)(hui)收藥(yao)物(wu)總(zong)(zong)量的(de)貢獻,前兩個膠帶(dai)應(ying)與剩余膠帶(dai)分(fen)(fen)(fen)開分(fen)(fen)(fen)析(xi)。為了增強分(fen)(fen)(fen)析(xi)檢測能(neng)力,可(ke)以將后續的(de)膠帶(dai)進(jin)行分(fen)(fen)(fen)組(例如(ru),每組含有所需的(de)最低含量的(de)SC)提取(qu)。SC中藥(yao)物(wu)的(de)總(zong)(zong)質(zhi)(zhi)量應(ying)計算為從(cong)所有膠帶(dai)樣本中提取(qu)的(de)總(zong)(zong)和。應(ying)確(que)定每個治療部位(wei)(wei)的(de)質(zhi)(zhi)量平衡,包括(kuo)通(tong)過(guo)清潔從(cong)表面去除的(de)藥(yao)物(wu)含量。一般情況下,可(ke)接受的(de)總(zong)(zong)回(hui)(hui)收率是90-110%;如(ru)果出現較大的(de)偏差,應(ying)充分(fen)(fen)(fen)解釋。

Cleaning the skin surface at the end of the application period prior to tape-stripping is important and must be capable of removing excess formulation (i.e. unabsorbed drug) efficiently without inadvertently ‘driving’ the drug into the barrier. The cleaning procedure usually involves quickly and gently wiping the skin with dry/wet tissue, cotton swabs and/or fresh alcohol wipes. The cleaning components should be known not to influence drug diffusion into and through the SC. A careful eva1uation and validation of an efficient skin cleaning procedure should be performed prior to the pivotal study, e.g. by demonstrating satisfactory recovery (>90%) of the drug formulation removed from the skin surface and the negligible drug content (<10%) recovered by stripping the cleaned skin immediately after application. Other ways of validation may be used if suitably justified.

在(zai)膠帶剝(bo)離前,非常重要的(de)是在(zai)應用(yong)期結束時(shi)進(jin)(jin)行皮(pi)膚(fu)表面的(de)清(qing)潔,必(bi)須能夠(gou)有效(xiao)地去(qu)除多(duo)余(yu)的(de)制劑(即未吸(xi)收的(de)藥(yao)物),而不(bu)會無意中“驅使”藥(yao)物進(jin)(jin)入屏(ping)障。清(qing)潔程序通常包括(kuo)用(yong)干/濕(shi)紙巾(jin)、棉簽和/或新鮮酒精濕(shi)巾(jin)快速(su)輕輕擦(ca)拭皮(pi)膚(fu)。應該知道清(qing)潔組件不(bu)會影響(xiang)藥(yao)物擴散進(jin)(jin)入和通過SC。在正式(shi)研(yan)究之前,應仔細(xi)評估(gu)和驗(yan)證有效的皮膚清潔程序,例如,通過(guo)證明從(cong)皮膚表面去除的制劑(ji)有令人滿意的回收率(>90%)和通過在施用后立即剝離清潔的皮膚而回收(shou)的可忽略的藥物含量(liang)(<10%)。如果能證(zheng)明合理(li)性,可以使(shi)用(yong)其他(ta)驗證(zheng)方法。

 

The bioanalytical method employed for drug quantification in the tape strips should be validated. The efficiency of the extraction procedures (including extraction of tape strips in groups) should be established and demonstrated as consistent prior to the pivotal study.

應驗證用于膠帶中藥(yao)物(wu)定量的生物(wu)分析方法。在(zai)正式研究之(zhi)前(qian),應(ying)確(que)定提取程(cheng)序的效率(lv)(包括成組提取膠帶),并證明其一致(zhi)性。

The discriminatory power of the TS method should be demonstrated for batches with different quality attributes (a negative control), such as a drug formulation with ±50% of the proposed product strength, that is shown to be statistically different and non-equivalent to the test and comparator products. The analytical methods for determining the content of active substance in the tape-stripped SC should be validated according to the Guideline on Bioanalytical Method Validation.

對于具有不同質量屬性的批次(陰性對照),應證明TS方法的區分力,例如具有±50%擬議產(chan)品強度的藥物配方,其與試驗(yan)和(he)對(dui)照產(chan)品在統計學上不同且不等效。根(gen)據(ju)《生(sheng)物分析方(fang)法(fa)驗證(zheng)指(zhi)南(nan)》,測定膠帶剝離(li)SC中活性物質含量的分(fen)析方法應進(jin)行驗證(zheng)

Data from all subjects should be reported and the validity and variability of the results should be discussed. All treated subjects and application sites should be included in the statistical analysis. The permitted reasons for exclusion must be pre-specified in the protocol. Data exclusion based on statistical analysis or for kinetic reasons alone is not acceptable.

應(ying)報告所有受試(shi)者(zhe)的數(shu)(shu)據,并討論結果的有效性和變異性。統計分析中應(ying)包括所有受試(shi)者(zhe)和應(ying)用部位。必須在(zai)協議中預(yu)先規定允許(xu)的排除理由。不能僅(jin)基于(yu)統計分析或動力學原因排除數(shu)(shu)據。

For each product, the thickness of SC removed, the number of tapes used and final TEWL value measured at both uptake and clearance times should be reported. Any differences in these parameters between the test and comparator products should be discussed with respect to equivalence.

對于每種(zhong)產(chan)品(pin)(pin),都應報(bao)告去除的SC厚度、使用的膠帶(dai)數量以及在吸(xi)收和清除時間測量的最終TEWL值。應在等效性方面(mian)對測試產(chan)品(pin)(pin)和對照(zhao)產(chan)品(pin)(pin)之間這些參數的任(ren)何差異都進(jin)行討論。

A plot of drug content profile in the SC should be presented for each application site, e.g. the drug content of each SC tape strip (single or grouped) versus SC depth.

應為(wei)每(mei)個應用部(bu)位繪(hui)制SC中的(de)藥(yao)物(wu)含量分布圖,例如每(mei)個SC膠帶條(單(dan)個或成組)的(de)藥(yao)物(wu)含量與SC深度的(de)關系(xi)。

The duplicated measurements for each product in each subject should be averaged (population geometric mean) prior to analysis.

在分析之前(qian),應對每(mei)個(ge)受試者中每(mei)個(ge)產品(pin)的重復測量值進行平(ping)均(總體幾(ji)何平(ping)均值)。

For the comparison of products, the equivalence parameters: mass of drug recovered from the uptake (Muptake) and clearance (Mclearance) sites, should be statistically compared, according to the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ).

對于產品的比較,應根據《生物等效性研究指南》(CPMP/EWP/QWP/1401/98 Rev.1/Corr)對等效參數:從吸收Muptake)和(he)清除(chu)(Mclearance)部位回收的藥物質量進行統計比較。

The acceptance criteria for equivalence parameters (Muptake) and (Mclearance) are:

The 90% confidence interval for the ratio of means of the test and comparator products should be contained within the acceptance interval of 80.00- 125.00%, unless justified.

除非有正(zheng)當理由,試(shi)驗和(he)對照產品平均值比率(lv)的90%置信區間(jian)應包含在80.00-125.00%的驗收區間(jian)內。

Wider 90% confidence interval limits, to a maximum of 69.84 – 143.19, may be accepted in the case of high variability observed with low strength and limited diffusion drug products, and if clinically justified. The procedure in the Guideline on Investigation of Bioequivalence,  “Section 4.1.10 Highly variable drugs or drug products” should be followed.

如(ru)果在低強度和有限擴散(san)的(de)藥(yao)物(wu)產(chan)(chan)品中觀察到高變(bian)異性(xing),并且在臨床證明的(de)情況下,可以接(jie)受更(geng)寬的(de)90%置信區間限,最大值為69.84–143.19。應遵(zun)循《生物(wu)等效性(xing)調查指(zhi)南》第4.1.10節“高變(bian)異藥(yao)物(wu)或藥(yao)物(wu)產(chan)(chan)品”中的(de)程序。

In addition, for the test to be valid:

此(ci)外,為(wei)了使測試有效

The acceptance criteria for equivalence parameters (Muptake) and (Mclearance)

等效(xiao)參數(Muptake)和(Mclearance)的(de)驗(yan)收標準

The 90% confidence interval for the ratio of means of the test and negative control products should be entirely outside the interval of 80.00- 125.00%.

試驗和陰性對照產品平均值比率的90%置信區間應完全超出80.00-125.00%的區間。The 90% confidence interval for the ratio of means of the comparator and negative control products should be entirely outside the interval of 80.00- 125.00%.對照產品和陰性對照品平均值之比的90%置信區間應完全超出80.00-125.00%的區間。The 90% confidence interval for the ratio of means of the test product clearance (Mclearance) and (Muptake) comparator products should be entirely below 1.0.試驗(yan)產(chan)品清除率(Mclearance)與(yu)對(dui)照產品(Muptake)平均值(zhi)之比(bi)的90%置信區間應完全低于1.0。

The 90% confidence interval for the ratio of means of the comparator product clearance (Mclearance) and (Muptake) comparator products should be entirely below 1.0.

對照產(chan)品清除率(Mclearance)與(yu)對照產品(Muptake)平均(jun)值(zhi)之比的90%置信(xin)區間應完全低(di)于1.0。

The overall conclusions of the study should be provided. This should be supported by a sound scientific discussion and interpretation of the TS data.

應提供研究的(de)總(zong)體結論(lun)。這應該(gai)得到對TS數據的(de)合理科學(xue)討論(lun)和解釋(shi)的(de)支持。

 

 

 

 

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