【文章內(nèi)容簡介】 The amount of material required for different tests will often depend on the actual potency and dosage form of the pound. 不同測試所需的物料的數(shù)量，往往取決于化合物的實際效力和劑型。38. A pilot plant can be regarded as a minimanufacturing setup中試工廠可以被看作是一個小型規(guī)模的制造機(jī)構(gòu)。3before transferring to a pilot plant, extensive evaluation and testing of the chemical synthesis is undertake to ensure that any changes and hazards are minimized.譯：在轉(zhuǎn)入中試工廠前，需要對化學(xué)合成進(jìn)行廣泛的評估和測試，以確保任何的改變和危害降至最低。40．Procedures are optimized，particular attention being paid to developing environmentally acceptable ways of disposing of waste products.（制備）程序要優(yōu)化，特別注重開發(fā)環(huán)境可接受的處置廢棄物的方法。 4 Commercial production of bulk drug substance for production of a drug，once approved and marketed，will likely take place on a larger scale or at a registered manufacturing plant.翻譯：一旦被批準(zhǔn)和銷售，藥品生產(chǎn)所用的大量原料藥，其商業(yè)化生產(chǎn)將可能采取更大規(guī)模進(jìn)行或在登記的制造工廠進(jìn)行。4The dosage form of a drug is the form by which it is administered to the patient. 藥物的劑型，是指病人服用藥物的方式。43 There are a vast array of possible dosage forms ranging from transderal patches to inhalers to intranasal medicines有大量從透皮貼片到滴鼻藥的可能劑型。moremondosageformsincludeoraltabletsorcapsles,oralliquids,topicalointmentsorcreams,andinjectables.較常見的劑型包括口服片劑或膠囊、口服液、局部藥膏或霜劑、和注射劑。 dosage form or forms chosen for a particular drug candidate will be defined in the target profile.特定候選藥物劑型或形態(tài)的選擇會在將目標(biāo)特性中被定義。 a more simple dosage form, for example an oral solution, is chosen for early clinical studies in human beings.有時，一個更簡單的劑型，例如含片，會被選擇來進(jìn)行早期人類臨床研究。47. This may save time and upfront costs at an early , highrisk stage of the drug development process. 在藥物開發(fā)過程中早期、高風(fēng)險的階段，這（早期臨床研究）可以節(jié)省時間和預(yù)付成本 clinical studies would use the expected marketed dosage form 后期的臨床研究將用到預(yù)期要銷售的劑型。thedosageform,thebinationofdrugandothermaterialswhichconstituteitmustfulfilcriteria 無論是什么劑型，藥物和其他（構(gòu)成藥物的）原料的組合必須符合標(biāo)準(zhǔn)。50、One of the most important is that of adequate stability 最重要的標(biāo)準(zhǔn)之一是有足夠的穩(wěn)定性。 means a predetermined potency level must remain after，for example ，two or three years 這意味著，預(yù)先確定的效力水平必須，例如，兩年或三年后，能繼續(xù)保持。52. The stability data generated on a dosage form will determine its shelflife and remended storage condition.一種劑型所產(chǎn)生的穩(wěn)定劑數(shù)據(jù)將決定它的保質(zhì)期和推薦的儲存條件。 in development the shelflife may be limited to several months.在開發(fā)的早期，其保質(zhì)期可能僅限于數(shù)月。willnotbeaproblemprovideditissufficienttocoveruseofthedrug overthedurationoftheclinicalstudyorstudies.翻譯：只要藥品的使用期限足以超過臨床研究或研究的階段，這（保質(zhì)期）就不會是個問題。adrugcandidateisgiventoman,itspharmacologicaleffectsonmajor systemsareofteninvestigatedinanumberofspecies. 在候選藥物給人服用之前，它關(guān)于主要系統(tǒng)的藥理作用往往在大量的物種上進(jìn)行了研究。 body systems studied include cardiovascular ,respiratory ,and nervous systems 。the effects on gross behavior can also be studied所研究的身體系統(tǒng)包括心血管系統(tǒng)，呼吸系統(tǒng)和神經(jīng)系統(tǒng)；對總體行為的影響也會研究。5 Experiments are sometimes conducted to see whether the drug candidate interferes with the actions of other medicines which, because of their specific effects or because of their mon use, are likely to be taken concurrently with the drug candidate進(jìn)行實驗有時是為了觀察候選藥物是否對其他藥物的作用有干擾，由于這些藥物的特殊的作用或者因為它們的普遍使用，它們可能要與候選藥物同時服用。58．Any synergism or antagonism of drug effects should be investigated, and any necessary warning issued to clinical inve