#آزمون سمیت سیستمیک تحت مزمن داخل صفاقی#آزمون سمیت تحت مزمن سیستمیک داخل صفاقی#آزمون سمیت تحت مزمن داخل صفاقی#آزمون سیستمیک تحت مزمن داخل صفاقی#Hcl,k sldj sdsjld; jpj lclk nhog wthrd#آزمون سمیت سیستمیک تحت مزمن داخل شکمی#آزمون سمیت تحت مزمن سیستمیک داخل شکمی#آزمون سمیت تحت مزمن داخل شکمی

آزمون سمیت سیستمیک تحت مزمن داخل صفاقی | Subchronic Intraperitoneal Toxicity 

آزمون سمیت تحت مزمن درون صفاقی، جهت ارزیابی پتانسیل سمیت محدوده وسیعی از مواد و محصولات پزشکی که در کاربری بالینی به شکل داخل شکمی (intraperitoneal) تجویز می شوند، در بازه 90 روزه پس از تجویز پیوسته (continuous dose) ماده در حیوانات آزمایشگاهی بکار می رود.

#آزمون سمیت سیستمیک تحت حاد زیرجلدی#آزمون سمیت تحت حاد سیستمیک زیرجلدی#subacute inracutaneous toxicity tests#آزمون سمیت تحت حاد زیرجلدی#آزمون سیستمیک تحت حاد زیرجلدی#Hcl,k sldj sdsjld; phn cdv[gnd#Hcl,k sldj phn cdv[gnd#آزمون سمیت سیستمیک تحت حاد زیر جلدی#آزمون سمیت تحت حاد سیستمیک زیر جلدی#subacute subcutaneous systemic toxicity tests

روش کار

در مجموعه آزمایشگاه های سنجش و پایش کیاژن فارما، آزمون سمیت تحت مزمن صفاقی بر روی موش نژاد سوری (NMRI) و یا رت آزمایشگاهی به صورت زیر انجام می شود:

• ۳ گروه اصلی در ۳ غلظت از ماده آزمایشی و در هر گروه 20 سر موش سوری ۶ تا ۸ هفته با میانگین وزن ۲۰ تا ۳۰ گرم جهت انجام آزمون در نظر گرفته خواهد شد.
• حیوانات هر گروه علامت گذاری خواهند شد.
• آزمایه ۵ تا 7 روز در هفته و به مدت 90 روز به داخل شکم حیوانات تزریق خواهد شد.
• در گروه کنترل، 20 سر موش مشابه روش بکار رفته در گروه های آزمایشی، تحت تیمار با حلال / حامل قرار خواهد گرفت.
• جهت بررسی برگشت پذیری و یا بروز علائم تاخییری سمیت، یک گروه اقماری (satellite group) همزمان با گروه های اصلی، تحت تیمار با بالاترین دوز آزمونه قرار خواهد گرفت.

#آزمون سمیت تحت حاد زیر جلدی#آزمون سیستمیک تحت حاد زیر جلدی#Hcl,k sldj sdsjld; jpj phn cdv [gnd#تست سمیت تحت حاد زیر جلدی#تست سیستمیک تحت حاد زیر جلدی#sldj jpj phn cdv[gnd

مشاهدات بالینی و میکروسکوپیک | Gross Necropsy and Histopathology

• در طول آزمون علایم بالینی ناشی از بیماری یا تیمار با ماده آزمایشی به دقت بررسی و در صورت مشاهده ثبت خواهد شد.
• مشاهدات، وزن کشی و میزان مصرف آب و غذا در حیوانات تحت آزمون، به صورت هفتگی و تا پایان تست، با توجه خاص به 4 هفته اول آزمون، انجام و ثبت خواهد شد.
• در پایان آزمون یا در نقطه پایان انسانی (humane endpoints)، کلیه حیوانات بر اساس موازین اخلاقی، معدوم و کالبدگشایی شده و اندام های داخلی شامل معده، کبد، کلیه ها، غدد فوق کلیوی، بیضه ها، اپیدیدیم، پروستات، تیموس، طحال، مغز، ریه، قلب و با توجه ویژه به بافت های هدف آزمون، وزن شده و مورد ارزیابی دقیق ماکروسکوپی (gross necropsy) و میکروسکوپی (histopathology) قرار خواهند گرفت.

#آزمون سیستمیک تحت مزمن داخل شکمی#subchronic intraperitoneal toxicity tests#آزمون سمیت سیستمیک تحت مزمن درون شکمی#آزمون سمیت تحت مزمن سیستمیک درون شکمی#تست سیستمیک تحت مزمن داخل صفاقی#subchronic intraperitoneal systemic toxicity tests#آزمون سمیت تحت مزمن صفاقی#آزمون سیستمیک تحت مزمن صفاقی#jsj sldj jpj lclk nhog a;ld

ل شکم

استاندارد های زیست سازگاری | References

ISO 10993-1: Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process.

ISO 10993-2: Biological Evaluation of Medical Devices – Animal welfare requirements.

ISO 10993-3: Biological Evaluation of Medical Devices – Tests for genotoxicity, carcinogenicity and reproductive toxicity.

ISO 10993-4: Biological Evaluation of Medical Devices – Selection of tests for interactions with blood.

ISO 10993-5: Biological Evaluation of Medical Devices – Tests for in vitro cytotoxicity.

ISO 10993-6: Biological Evaluation of Medical Devices – Tests for local effects after implantation.

ISO 10993-7: Biological Evaluation of Medical Devices – Ethylene oxide sterilization residuals.

ISO 10993-8: Biological Evaluation of Medical Devices – Selection and qualification of reference materials for biological tests.

ISO 10993-9: Biological Evaluation of Medical Devices – Framework for identification and quantification of potential degradation products.

ISO 10993-10: Biological Evaluation of Medical Devices – Tests for skin sensitization.

ISO 10993-11: Biological Evaluation of Medical Devices – Tests for systemic toxicity.

ISO 10993-12: Biological Evaluation of Medical Devices – Sample preparation and reference materials.

ISO 10993-13: Biological Evaluation of Medical Devices – Identification and quantification of degradation products from polymeric medical devices.

ISO 10993-14: Biological Evaluation of Medical Devices – Identification and quantification of degradation products from ceramics.

ISO 10993-15: Biological Evaluation of Medical Devices – Identification and quantification of degradation products from metals and alloys.

ISO 10993-16: Biological Evaluation of Medical Devices – Toxicokinetic study design for degradation products and leachables.

ISO 10993-17: Biological Evaluation of Medical Devices – Toxicological risk assessment of medical device constituents.

ISO 10993-18: Biological Evaluation of Medical Devices – Chemical characterization of medical device materials within a risk management process.

ISO 10993-19: Biological Evaluation of Medical Devices – Physico-chemical, morphological and topographical characterization of materials.

ISO 10993-20: Biological Evaluation of Medical Devices – Principles and methods for immunotoxicology testing of medical devices.

ISO 10993-22: Biological Evaluation of Medical Devices – Guidance on nanomaterials.

ISO 10993-23: Biological Evaluation of Medical Devices – Tests for irritation.

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OECD Test No. 432: Guidelines for the Testing of Chemicals – In Vitro 3T3 NRU Phototoxicity Test.

OECD Test No. 433: Guidelines for the Testing of Chemicals – Acute Inhalation Toxicity: Fixed Concentration Procedure.

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OECD Test No. 435: Guidelines for the Testing of Chemicals – In Vitro Membrane Barrier Test Method for Skin Corrosion.

OECD Test No. 436: Guidelines for the Testing of Chemicals – Acute Inhalation Toxicity – Acute Toxic Class Method.

OECD Test No. 437: Guidelines for the Testing of Chemicals – Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage.

OECD Test No. 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage.

OECD Test No. 439: Guidelines for the Testing of Chemicals – In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method.

OECD Test No. 440: Guidelines for the Testing of Chemicals – Uterotrophic Bioassay in Rodents.

OECD Test No. 441: Guidelines for the Testing of Chemicals – Hershberger Bioassay in Rats.

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OECD Test No. 442B: Guidelines for the Testing of Chemicals – Skin Sensitization – Local Lymph Node Assay: BrdU-ELISA or –FCM.

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OECD Test No. 443: Guidelines for the Testing of Chemicals – Extended One-Generation Reproductive Toxicity Study.

OECD Test No. 451: Guidelines for the Testing of Chemicals – Carcinogenicity Studies.

OECD Test No. 452: Guidelines for the Testing of Chemicals – Chronic Toxicity Studies.

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OECD Test No. 455: Guidelines for the Testing of Chemicals – Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists.

OECD Test No. 456: Guidelines for the Testing of Chemicals – H295R Steroidogenesis Assay.

OECD Test No. 457: Guidelines for the Testing of Chemicals – BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and Antagonists.

OECD Test No. 458: Guidelines for the Testing of Chemicals – Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals.

OECD Test No. 460: Guidelines for the Testing of Chemicals – Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants.

OECD Test No. 471: Guidelines for the Testing of Chemicals – Bacterial Reverse Mutation Test.

OECD Test No. 473: Guidelines for the Testing of Chemicals – In Vitro Mammalian Chromosomal Aberration Test.

OECD Test No. 474: Guidelines for the Testing of Chemicals – Mammalian Erythrocyte Micronucleus Test.

OECD Test No. 475: Guidelines for the Testing of Chemicals – Mammalian Bone Marrow Chromosomal Aberration Test.

OECD Test No. 476: Guidelines for the Testing of Chemicals – In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes.

OECD Test No. 477: Guidelines for the Testing of Chemicals – Genetic Toxicology: Sex-Linked Recessive Lethal Test in Drosophila melanogaster.

OECD Test No. 478: Guidelines for the Testing of Chemicals – Rodent Dominant Lethal Test.

OECD Test No. 479: Guidelines for the Testing of Chemicals – Genetic Toxicology: In vitro Sister Chromatid Exchange Assay in Mammalian Cells.

OECD Test No. 480: Guidelines for the Testing of Chemicals – Genetic Toxicology: Saccharomyces cerevisiae, Gene Mutation Assay.

OECD Test No. 481: Guidelines for the Testing of Chemicals – Genetic Toxicology: Saacharomyces cerevisiae, Miotic Recombination Assay.

OECD Test No. 482: Guidelines for the Testing of Chemicals – Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells in vitro.

OECD Test No. 483: Guidelines for the Testing of Chemicals – Mammalian Spermatogonial Chromosomal Aberration Test.

OECD Test No. 484: Guidelines for the Testing of Chemicals – Genetic Toxicology: Mouse Spot Test.

OECD Test No. 485: Guidelines for the Testing of Chemicals – Genetic toxicology, Mouse Heritable Translocation Assay.

OECD Test No. 486: Guidelines for the Testing of Chemicals – Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo.

OECD Test No. 487: Guidelines for the Testing of Chemicals – In Vitro Mammalian Cell Micronucleus Test.

OECD Test No. 488: Guidelines for the Testing of Chemicals – Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays.

OECD Test No. 489: Guidelines for the Testing of Chemicals – In Vivo Mammalian Alkaline Comet Assay.

OECD Test No. 490: Guidelines for the Testing of Chemicals – In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene.

OECD Test No. 491: Guidelines for the Testing of Chemicals – Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage.

OECD Test No. 492: Guidelines for the Testing of Chemicals – Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage.

OECD Test No. 493: Guidelines for the Testing of Chemicals – Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity.

OECD Test No. 494: Guidelines for the Testing of Chemicals – Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage.

OECD Test No. 495: Guidelines for the Testing of Chemicals – Ros (Reactive Oxygen Species) Assay for Photoreactivity.

OECD Test No. 496: Guidelines for the Testing of Chemicals – In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage.

OECD Test No. 497: Guidelines for the Testing of Chemicals – Defined Approaches on Skin Sensitisation.

OECD Test No. 498: Guidelines for the Testing of Chemicals – In vitro Phototoxicity – Reconstructed Human Epidermis Phototoxicity test method.

OECD Test No. 19: Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Monograph Series on Testing and Assessment.

#آزمون سمیت سیستمیک تحت مزمن داخل صفاقی#آزمون سمیت تحت مزمن سیستمیک داخل صفاقی#آزمون سمیت تحت مزمن داخل صفاقی#آزمون سیستمیک تحت مزمن داخل صفاقی#Hcl,k sldj sdsjld; jpj lclk nhog wthrd#آزمون سمیت سیستمیک تحت مزمن داخل شکمی#آزمون سمیت تحت مزمن سیستمیک داخل شکمی#آزمون سمیت تحت مزمن داخل شکمی

#آزمون سیستمیک تحت مزمن داخل شکمی#subchronic intraperitoneal toxicity tests#آزمون سمیت سیستمیک تحت مزمن درون شکمی#آزمون سمیت تحت مزمن سیستمیک درون شکمی#تست سیستمیک تحت مزمن داخل صفاقی#subchronic intraperitoneal systemic toxicity tests#آزمون سمیت تحت مزمن صفاقی#آزمون سیستمیک تحت مزمن صفاقی#jsj sldj jpj lclk nhog a;ld

#تست سمیت سیستمیک تحت مزمن درون صفاقی#تست سمیت تحت مزمن سیستمیک درون صفاقی#تست سمیت تحت مزمن درون صفاقی#تست سیستمیک تحت مزمن درون صفاقی#تست سمیت سیستمیک تحت مزمن صفاقی#تست سمیت تحت مزمن سیستمیک داخل صفاقی#تست سمیت تحت مزمن داخل صفاقی

#آزمایشگاه همکار سازمان ملی استاندارد #آزمایشگاه همکار سازمان غذا و دارو#آزمایشگاه همکار اداره کل تجهیزات پزشکی#آزمایشگاه سنجش و پایش کیاژن فارما#آزمایشگاه کیاژن فارما#آزمایشگاه کنترل کیفی کیاژن فارما#تعرفه آزمون های زیست سازگاری#قیمت آزمون های زیست سازگاری#قیمت آزمون های سم شناسی#تعرفه آزمون های سم شناسی

#آزمون های کالای وارداتی#آزمون های کالای صادراتی#آزمون های تولیدات دارویی#همکار شرکت های دارویی #Kiagenpharma# Kiagen# اصلاح و نباتات #آزمون های تخصصی گمرکی#آزمون های گمرکی