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Persian (Farsi) to English - Rates: 0.07 - 0.12 AUD per word / 30 - 40 AUD per hour English to Persian (Farsi) - Rates: 0.07 - 0.12 AUD per word / 30 - 40 AUD per hour
Persian (Farsi) to English: Excerpt from Article "Subchronic Toxicity Evaluation of Recombinant Human Growth Hormone"
Source text - Persian (Farsi) 3- روش کار
3-1 نوع تحقيق : مطالعه تجربي Experimental study) )
3-2 جامعه مورد مطالعه تحقيق :
بر اساس دستورالعمل اختصاصي مطالعه سميت تحت مزمن هورمون رشدانساني که توسط1 EMEA تهيه شده و مبناي تهيه پروتوکل طرح تحقيقاتي حاضر نيز مي باشد ، استفاده از يک سويه حيواني در مقايسه باRMP(Reference Medical Product) کفايت مي کند. از آنجائيکه سويه حيواني مورد مطالعه در مطالعات تحت حاد همين فراورده ، Wistar Rat بوده است لذا در اين مطالعه نيز از رت نر و ماده نژاد Wistar تهيه شده از انستيتو پاستور استفاده گرديد.
3-3 محيط تحقيق : محيط تحقيق دراين مطالعه، آزمايشگاه تحقيقاتي سم شناسي و داروشناسي واحد علوم دارويي دانشگاه آزاد اسلامي بوده است .پس از تهيه نمونه هاي خوني ،کليه تست هاي هماتولوژيک، بيوشيميايي و ادراري در آزمايشگاه مجتمع بيمارستاني امام خميني (ره)دانشگاه علوم پزشکي تهران صورت گرفته است.پس ازانجام نکروپسي و فيکس کردن بافت ها در فرمالين 10% در آزمايشگاه تحقيقاتي سم شناسي و داروشناسي واحد علوم دارويي ،کليه مطالعات پاتولوژيک اعم از تهيه بلوک پارافينيزه ، تهيه و رنگ آميزي H&E اسلايد ها و بررسي هاي ميکروسکوپيک در شرکت عاج طب تهران به انجام رسيده اند.
3-4 مشخصات نمونه
نمونه هاي مورد مطالعه دراين تحقيق 90 عدد رت ويستار(45 نر و45 ماده ) 6-4 هفته اي بوده اند.
براي ورود هررت به اين مطالعه معيارهاي زير رعايت گرديده اند:
1- معيارهاي ورود:
اطلاع از سن دقيق حيوان که سن 6-4 هفته در هردو گروه نر و ماده رعايت گرديد.
اطلاع از وزن دقيق حيوانات بطوريکه تنها حيوانات با وزن بين 100- 80 گرم اجازه ورود به مطالعه را داشتند.
برخوردار بودن از معاينه فيزيکي توسط دامپزشک و اطمينان از سلامتي کامل حيوان
طي کردن زمان Adaptation با محيط ( 10 روز )
3-5 کدگذاري حيوانات : با استفاده از دستورالعمل European Medicines Agency Doc.Ref:EMEA/89166/2006 دسته بندي و کد گذاري حيوانات صورت گرفت.در اين دستورالعمل مقايسه ترکيب با گروه داروي رفرانس RMP جهت تاييد safety ترکيب ضروري شناخته شده است لذا تمام مراحل مطالعه بطور يکسان در سه گروه تست ، رفرانس و کنترل لحاظ گرديدند.در مجموع 90 حيوان واردمطالعه شده به شش گروه مساوي دسته بندي گرديدند.
در گروه ماده 3 گروه 15 عددي به شرح زير جهت بررسي و مطالعه انتخاب گرديد :
1-گروه تست (FT) که تحت رژيم هورمون رشد انساني شرکت داروسازي ثامن قرار گرفتند.
2- گروه کنترل (FC) تحت رژيم حلال فراورده (آب قابل تزريق شرکت داروسازي ثامن ) قرار گرفتند .
3- گروه رفرانس (FR) که تحت رژيم هورمون رشد انساني شرکت داروسازي Novo قرار گرفتند.
به همين ترتيب در گروه نر نيز سه زير گروه 15 تايي رت ويستار 6-4 هفته اي زير تعريف گرديدند:
1--گروه تست (MT) که تحت رژيم هورمون رشد انساني شرکت داروسازي ثامن قرار گرفتند.
2- گروه کنترل (MC) که تحت رژيم حلال فراورده (آب قابل تزريق شرکت داروسازي ثامن ) قرار گرفتند .
3- گروه رفرانس (MR) که تحت رژيم هورمون رشد انساني شرکت داروسازي Novo قرار گرفتند.
به منظور جلوگيري از بروز Bias در تحقيق ،کدگذاري تاروشن شدن نتايج کاملا محرمانه باقي ماندبطوريکه هيچيک از همکاران دخيل در تفسير داده ها، از نحوه کدبندي نمونه ها آگاهي نداشتند.
3-6: نحوه ارزيابي سميت
سازگارکردن حيوانات : حيوانات تحت مطالعه در زمان خريداري و شروع مطالعه به مدت 10 روز جهت سازگاري با محيط حيوانخانه و انجام معاينات فيزيکي توسط دامپزشک تحت کنترل بود ه وشرايط حيوانخانه به گونه اي بود که حيوانات در طول مدت مطالعه روزانه 12 ساعت در معرض نور طبيعي و 12 ساعت در تاريکي قرار گرفتند ، از غذايي با شماره سريال ثابت و آب تصفيه شده بهره برداري نموده ، شرايط بهداشتي ، حرارت (22 ±3 ) و رطوبت کاملا تحت کنترل و نظارت روزانه بوده است.حيوانات هرگروه طي مدت 10 روز نسبت به شرايط زيست محيطي تطابق مطلوبي پيدا کرده ،پيش از شروع مطالعه از سلامتي و صحت کليه حيوانات اطمينان کامل حاصل گرديد.
تجويز دارو : بر اساس دستورالعمل هاي موجود ، نحوه تجويزدارو مشابه با راه تجويز انساني در هر شش گروه بصورت subcutaneous(sc) و برمبناي وزن بدن صورت پذيرفت .
مواد مورد استفاده : در گروه تست از ويال 4IU شرکت داروسازي ثامن ، در گروه رفرانس از ويال 4IU Norditropin ساخت شرکت Novo Nordisk و در گروه کنترل از آب قابل تزريق شرکت داروسازي ثامن استفاده شد.
دوز دارو: با توجه به نتايج مطالعات اوليه و rang finding tests ، تحقيقات مشابه،خواص فراورده ، تحمل پذيري حيوان نسبت به دوزهاي تجويز شده ، limit test انجام شده در اين مطالعه ، امکانات موجود و ميزان دسترسي به فراورده رفرانس و بر اساس دستورالعمل کتب مرجع ، دوز انتخابي معادل 1000µg/kg body weight per day بوده و با استفاده از محلول 1000µg /ml تجويز گرديد. از آنجائيکه دوز انساني اين فراورده در کودکان 25 µg/kg body weight per day است و حيوانات مورد استفاده در تحقيق نيز تماما نابالغ بوده اند لذا دوز مورد استفاده در تحقيق 40 برابر دوز درماني کودکان و 10 برابر دوز درماني بزرگسالان (100µg/kg body weight per day) و معادل Maximum Tolerated Dose(MTD) طي تست هاي مقدماتي بوده است .اين دوز روزانه پس از تهيه محلول ,1mg/mlپس از توزين دقيق حيوانات به سه گروه تست ، رفرانس و کنترل تجويز شد .
زمان تجويز : کليه تزريق هاي اين مطالعه مشابه با الگوي انساني در ساعات پاياني روز و نزديک به غروب افتاب صورت پذيرفت.
مدت زمان مطالعه : اگرچه طبق دستورالعمل مرجع1 ، 4 هفته جهت مطالعه سميت تحت مزمن هورمون رشد انساني کفايت مي نمايد اما به منظور صحت و دقت هرچه بيشتر ، زمان اين مطالعه به 45 روز افزايش و 45 روز نيز بعنوان زمان recovery در نظر گرفته شد تا درصورت مشاهده عوارض سمي داروها برگشت پذير بودن آنها نيز به محک گذاشته شود.. حيوانات شش گروه تا پايان دوران recovery تحت نظارت و معاينات فيزيکي دقيق بوده و کليه اطلاعات آنها ثبت شده است.
مشاهدات و معاينات باليني: از زمان ورود حيوانات به محيط حيوانخانه ،حيوانات روزانه 2 بار جهت مرگ و مير و پاسخ هاي توکسيک تحت بررسي قرار گرفته و بصورت هفتگي تحت معاينه دامپزشک قرار گرفتندکه اين کار تا انتهاي زمان مطالعه و در دوران recovery تداوم داشت .دراين مشاهدات باليني ، هرگونه تغيير در وضعيت پوست ،مو، چشم ، مخاط ، دستگاه تنفس، دستگاه قلب و عروق و تغييرات رفتاري و تغيير در وضعيت ظاهري ادرار و مدفوع حيوانات ثبت گرديد.
شرح دقيق معاينات فيزيکي طبق استاندارد در جدول زير ذکر گرديده اند:
Cageside Observations
Home –Cage Activity
Feces Amount
Feces Color
Feces Consistency
Urine Amount
Urine Color
Behavior While Removing From Cage
Neurological Examinations
Tail Elevation
Abnormal Gait
Ataxic Gait
Head Position
Physical Examinations
Death
Hair Coat
Mucus Membrane/Eye/Skin Color
Body Temperature
Respiratory Rate
Respiratory Character
Lacrimation
Salivation Amount
Eye Prominence
توزين : وزن حيوانات بصورت روزانه با ترازوي ديجيتالي ( تا پايان 45 روز) و وزن ارگانها در زمان نکروپسي ( در 5 نوبت) بطور کامل ثبت گرديدند.
تهيه نمونه خون:مجموعا در 8 نوبت 4 بار از حيوانات گروه نر و4 باراز حيوانات ماده ( پيش از مطالعه ، روز 21 ، روز 45 و روز90) نمونه خون لخته و هپارينيزه تهيه گرديد.براي هر بار نمونه گيري از سه حيوان بصورت تصادفي از ميان حيوانات هرگروه استفاده شد.نمونه هاي اخذ شده در ظروف مخصوص به آزمايشگاه مجتمع درماني بيمارستان امام خميني ( دانشگاه علوم پزشکي تهران) انتقال يافت.اطلاعات در خصوص روش دقيق آناليزهاي هماتولوژيک و بيوشيميايي و کيت هاي مورد استفاده در دسترس وجملگي معتبر مي باشند.
پارامترهاي مورد بررسي در بخش هماتولوژي شامل موارد ذيل بودند:
White blood cell count (WBC), Red blood cell count (RBC), Hemoglobin (Hb), HCT,MCV,MCH,MCHC,PLT, Neut.,Lymph,Mono.
پارامترهاي مورد بررسي در بخش بيوشيميايي شامل موارد ذيل بوده اند:
Total protein (TP), Albumin (Alb), Total bilirubin (T. Bil), D.Bil, Asparatate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase (ALP), Total cholesterol (cho), Urea, Creatinine (Cr), FBS.
تهيه نمونه ادرار: مجموعا در 8 نوبت 4 بار از حيوانات گروه نر و4 باراز حيوانات گروه ماده ( پيش از مطالعه ، روز 21 ، روز 45 و روز90) نمونه ادرار 24 ساعته با استفاده از دستگاه مخصوص جمع آوري ادرار موش تهيه گرديد.براي هر بار نمونه گيري از سه حيوان بصورت تصادفي از ميان حيوانات هرگروه استفاده شد.نمونه هاي اخذ شده در ظروف مخصوص و مناسب به آزمايشگاه مجتمع درماني بيمارستان امام خميني ( دانشگاه علوم پزشکي تهران) انتقال يافت.
تهيه نمونه و مطالعات پاتولوژيک : نمونه بافتي از احشاي حيوانات در 3 زمان از شش گروه ( روز 21، روز 45 و روز 90) تهيه گرديد . در زمان نکروپسي حيوانات بصورت اتفاقي انتخاب و پس از بيهوش شدن با اتر،نمونه هاي بافتي آنها تهيه و جهت مطالعات هيستو پاتولوژي آماده گرديدند. در اين مطالعه احشاي کليه نمونه هاي فوق که شامل 14 حيوان بودند ، پس از بيهوش کردن حيوانات از بدن خارج گرديده وپس از توزين در محلول فرمالين 10% فيکس گرديدند تا پس از انتفال به بخش پاتولوژي مورد برش و رنگ آميزي واقع شوند.احشاي مورد مطالعه در اين طرح شامل قلب، کبد، کليه ها، آدرنال ، پانکراس ،طحال ، معده ،مري روده کوچک ، کولون و رکتوم ، رحم ،لوله هاي فالوپ ، حالب ،تخمدان ، عضله مخطط ، تيروئيد ، پاراتيروئيد ،ريه و مجاري تنفسي ، حنجره ،معده، بيضه ، مثانه ، اپيديديم ،وزيکول سمينال وتيموس بوده اند.که پس از توزين و ثبت وزن ارگانهادر هريک از گروه ها ،مطالعات مربوطه در مقايسه با گروه کنترل زمان تست صورت گرفت
مطالعات آماري : متغيرهاي پيوسته بصورتSEM means+ ذکر شده و متغيرها ناپيوسته بصورت کمي (Frequency) گزارش شد.جهت مقايسه ميانگين متغيرها از t-test و جهت آناليز واريانس ازدو روش Anova يک طرفه وLevene’s Test for Equality of Variances استفاده شد و p
Translation - English 3- Study method
1-3 Study type: experimental study.
2-3 Research study population:
Based on specific guidelines for subchronic studies on human growth hormone issued by EMEA1 which forms the basis for current research study, using one animal species in comparison to RMP (Reference Medical Product) is considered sufficient. The animal species used for subchronic study of this product was Wistar rat, therefore male and female Wistar rats were procured from Pasteur Institute.
3-3 Research site: research site for this study was Toxicology and Pharmacology Research Laboratory of Pharmaceutical Sciences Division, Islamic Open University. After preparing blood samples, all hematological, biochemical and urine tests were performed in Imam Khomeini Hospital Complex Lab, Tehran University of Medical Sciences. Following necropsy and tissue fixation in formalin 10% in Toxicology and Pharmacology Research Laboratory of Pharmaceutical Sciences Division, all pathological studies including preparation of paraffin blocks, processing and staining, H&E slide preparation and microscopic evaluations were carried out at Tehran Āj Teb Co.
3-4 Test subject characteristics:
Study subjects in this study were 90 Wistar rats (45 males and 45 females) of 4-6 weeks old.
For each rat to be included in the study, the following criteria were considered:
1- Inclusion criteria:
Knowing animal's exact age; an age of 4-6 weeks must be considered for both males and females.
Knowing exact weight of subjects so as to only allow animals of 80-100gr to enter the study.
Having been physically examined by a veterinarian confirming subject’s total health.
Having passed environmental adaptation period (for 10 days)
3-5 Animal coding: using European Medicines Agency guideline EMEA/89166/2006, animal subjects were classified and numbered. Comparing the product under study with a reference medical product (RMP) in order to validate its safety, is a requirement of this guideline. Consequently, all stages of the study have been identically organized in test, reference and control groups. On the whole, 90 animals were included in study and divided into six equal groups.
In female group, 3 groups of 15 rats were selected for evaluation and study:
1- Test group (FT) that was given human growth hormone produced by Samen Pharm. Co.
2- Control group (FC) that was given product’s solvent (water for injection produced by Samen).
3- Reference group (FR) that was given human growth hormone produced by NovoNordisk.
[page 7]
In the same fashion as above, male group was divided into three subgroups of 15 rats of 4-6 weeks old:
1- Test group (MT) that was given human growth hormone produced by Samen Pharm. Co.
2- Control group (MC) that was given product’s solvent (water for injection produced by Samen).
3- Reference group (MR) that was given human growth hormone produced by NovoNordisk.
To prevent any bias in the research, coding method was kept confidential till results were produced and consequently, none of the staff involved in data interpretation were aware of the coding system of subjects.
3-6: Toxicity determination method
Animal adaptation: upon purchase and before starting the study, animal subjects were kept under control for 10 days in order to adapt to animal facility environment and for physical examinations by veterinarian; animal facility conditions were thus that animals were kept for 12 hours exposed to natural lighting and 12 hours in darkness, animals were provided with foodstuff bearing fixed serial number plus treated water, hygienic conditions and a temperature of 22±3°C along with humidity, were fully controlled on a daily basis. Animals of each group properly adapted to their living environment within 10 days. Prior to initiation of study, it was ensured that all animals were in good health.
Product administration: according to existing guidelines, administration method was similar to humans, i.e. via subcutaneous (SC) route for all six groups and based on body weight.
Products used: 4 IU vials produced by Samen in test group, 4 IU Norditropin vials produced by NovoNordisk in reference group and sterile water for injection produced by Samen was used in control group.
Dosage: considering preliminary studies and range-finding tests, similar researches, product properties, animal tolerance towards administered doses, limit tests performed in this study, available resources and accessibility of the reference product and recommendations of reference literature guidelines, selected dosage was 1000 µg/Kg body weight per day and the product was administered using a 1000 µg/ml solution. Given that this product’s dosage in children is 25 µg/Kg body weight per day and none of the animals used in this study were adults, therefore the dosage used in research during the preliminary tests was designated as 40 times that of pediatric and 10 times that of adult therapeutic dose (100 µg/Kg body weight per day) and equal to maximum tolerated dose (TMD); after preparation of 1 mg/ml solution and precise weighing of animals, the said dose was administered in each of the of test, reference and control groups on a daily basis.
Time of administration: all study injections were administered at the end of daytime hours and close to sunset, similar to human models.
[page 8]
Duration of the study: Despite the recommendation by reference guidelines that 4 weeks is adequate time for human growth hormone subchronic toxicity study, study duration was increased to 45 days and another 45 days were set as recovery period, so as to assess reversibility of toxic conditions likely to be observed. Animals belonging to all six groups were under supervision and careful physical examination until the end of recovery period and all relevant data thereof was recorded.
Clinical observations and examinations: Since they were introduced to animal facility until the end of study period and throughout the recovery period, animals were monitored for mortality rate and toxic responses twice daily and were weekly examined by a veterinarian. During these clinical observations, any changes in conditions related to skin, hair, eyes, mucous membranes, respiratory and cardiovascular systems, as well as behavioral changes and changes in feces and urine appearance, were recorded.
A detailed description of physical examinations according to standards have been mentioned below:
Cage side observations
Home-cage activity
Feces amount
Feces color
Feces consistency
Urine amount
Urine color
Behavior while removing from cage
Neurological examinations
Tail elevation
Abnormal gait
Ataxic gait
Head position
Physical examinations
Death
Hair coat
Mucous membrane/eye/skin color
Body temperature
Respiratory rate
Respiratory character
Lacrimation
Salivation amount
Eye prominence
Weighing: animals were weighed daily using a digital scale (until the end of 45 days) and organ weights were measured at necropsy (in 5 instances) and figures were comprehensively recorded.
Blood sample preparation: samples of blood clot and heparinized blood were prepared on a total of 8 occasions; 4 times from male group animals and 4 times from female animals (prior to study, day 21, day 45, day 90). For every instance of sample withdrawal, three animals were randomly selected from among each group. Withdrawn samples were transferred in special vessels
[page 9]
to Imam Khomeini Hospital Treatment Complex Lab. (Tehran University of Medical Sciences). All information regarding exact methods of hematological and biochemical analysis methods and kits that were utilized are available and fully approved.
Parameters being measured and evaluated in hematology department were as follows:
White blood cell count (WBC), red blood cell count (RBC), hemoglobin (Hb), HCT, MCV, MCH, MCHC, PLT, neutrophil, lymphocyte, monocyte.
Parameters being measured and evaluated in biochemistry department were as follows:
Total protein (TP), albumin (Alb), total bilirubin (T. Bil), direct bilirubin (D. Bil), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total cholesterol (cho), urea, creatinine (Cr), FBS.
Urine sample preparation: samples of 24 hour urine were prepared using special mouse urine collection device on a total of 8 occasions; 4 times from male group animals and 4 times from female group animals (prior to study, day 21, day 45 and day 90). For every instance of sample withdrawal, three animals were randomly selected from among each group. Withdrawn samples were transferred in special suitable vessels to Imam Khomeini Hospital Treatment Complex Lab. (Tehran University of Medical Sciences).
Sample preparation for pathological studies: tissue samples from animal viscera were taken from six groups on 3 occasions (day 21, day 45 and, day 90). Animals were randomly selected at necropsy and tissue samples were taken after being anesthetized by ether and prepared for histopathological studies. In this study, viscera of the study subjects including 14 animals, were excised following anesthesia and fixated in formalin 10% solution to prepare sections from and be subjected to staining after being transferred to pathology lab. Organs under study in this project included heart, kidneys, adrenal glands, pancreas, spleen, stomach, esophagus, small intestine, colon and rectum, uterus, fallopian tubes, ureters, ovaries, skeletal muscles, thyroid, parathyroid, lungs and respiratory tracts, larynx, testicles, bladder, epididymis, seminal vesicle and thymus which subsequent to being weighed and having their weights recorded, were subjected to evaluation in comparison to control group.
Statistical analysis: continuous variables were expressed as mean ± SEM (standard error of the mean) and discontinuous variables as quantitative figures (frequency). In order to compare mean of variables, t-test was carried out and one-way ANOVA and Leven’s test for equality of variances was used for analysis of variance and a p-value of
English to Persian (Farsi): Excerpt from Artaviraf Namak (ca. 250-350 AD)
Source text - English [Part 4. Hell]
CHAPTER 16.
1. Afterward, Srosh the pious, and Adar the angel, took hold of my hand, and I went thence onward. (2) I came to a place, and I saw a great river which was gloomy as dreadful hell; (3) on which river were many souls and guardian angels; (4) and some of them were not able to cross, and some crossed only with great difficulty, and some crossed easily.
5. And I asked thus: 'What river is this? and who are these people who stand so distressed?'
6. Srosh the pious, and Adar the angel, said (7) thus: 'This river is the many tears which men shed from the eyes, as they make lamentation and weeping for the departed. (8) They shed those tears unlawfully, and they swell to this river. (9) Those who are not able to cross over are those for whom, after their departure, much lamentation and weeping were made; (10) and those who cross more easily are those for whom less was made. (11) Speak forth to the world thus: 'When you are in the world, make no lamentation and weeping unlawfully; (12) 'for so much harm and difficulty may happen to the souls of your departed.
Translation - Persian (Farsi) [بخش 4. دوزخ]
فرگرد 16.
سپس، سُروش فربوددين و آذر فِريشته، دست فراز گرفتند، و من زانجا پيش برفتم. بجايي دررسيدم و رودي بديدم تيره‌گون و دُشگُذرچون دوزخ ترسناك كه اندر آن پرشمار روانها و فروهرها همي‌بودند؛ و برخي شان گذشتن از آن نيارستند و برخي تنها بسختي فراوان گذشتند، و برخي بسادگي همي‌گذشتند.
پرسيدم كه: ”اين رود چيست؟ و اين مردمان كه اندر آن چنين پريشيده‌اند، كيستند؟“
سُروش فربوددين و آذر فريشته فرمودند كه: ”اين رود از انبوه سرشكي است كه مردمان در سوگ و مويه‌ي درگذشتگان از ديده همي‌افشانند. چون ايشان به ناروا گريند، مر اين رود را خروشان همي‌‌سازند. آنانكه گذر را نيارند، همانند كه از پس رفتنشان، مويه و زاري فراوان گرديده؛ و آنان كه آسانتر گذرند، مرا ايشان را اندك شيون بودست.
زان پس جهانيان را چنين گوي كه: “هر دم كه در گيتي‌ايد، به ناروا شيون و زاري مكنيد؛ ازيرا كه روان رفتگان شما را بسي رنج و سختي شايد همي‌رسد.“
Though my major is pharmaceutics with a strong affiliation towards industrial pharmacy and biotechnology, my extensive study and experience in non-medical/pharm. areas as diverse as Persian history and literature, computer software and hardware and, astrophysics and cosmology, contributes to a level of quality and versatility that one does not commonly come across in the translation arena. Being constantly surrounded by reference literature of varying subjects in conjunction with English/Persian lexical corpus, I am capable of coining novel Persian/English equivalents in my fields of interest and specialty. I retain an encyclopedic style and mindset that enables me to cope with translation jobs in a systematic and verbatim fashion, ergo, translation is not a bungle work for me but rather a passion.
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