◆ Toxicological Testing
● Testing Services
Test Item | Standard or Guideline |
Acute Oral Toxicity Study | GB 15193.3 |
28-Day Oral Toxicity Study | GB 15193.22 |
90-Day Oral Toxicity Study | GB 15193.13 |
Teratogenicity Study | GB 15193.14 |
Reproductive Toxicity Study | GB 15193.15 |
Toxicokinetic Study | GB 15193.16 |
Combined Chronic Toxicity and Carcinogenicity Study | GB 15193.17 |
Reproductive and Developmental Toxicity Study | GB 15193.25 |
Chronic Toxicity Study | GB 15193.26 |
Carcinogenicity Study | GB 15193.27 |
Extended One-Generation Reproductive Toxicity Study | GB 15193.29 |
In Vivo Mammalian Alkaline Comet Assay | GB 31655 |
Bacterial Reverse Mutation Test | GB 15193.4 |
Mammalian Erythrocyte Micronucleus Test | GB 15193.5 |
Mammalian Bone Marrow Chromosomal Aberration Test | GB 15193.6 |
Mouse Spermatogonia or Spermatocyte Chromosomal Aberration Test | GB 15193.8 |
In Vitro Mammalian Cell HGRT Gene Mutation Assay | GB 15193.12 |
In Vitro Mammalian Cell TK Gene Mutation Assay | GB 15193.20 |
In Vitro Mammalian Chromosomal Aberration Test | GB 15193.23 |
Drosophila melanogaster Sex-Linked Recessive Lethal Test | GB 15193.11 |
In Vitro Mammalian Cell DNA Damage Repair (Unscheduled DNA Synthesis) Test | GB 15193.10 |
Rodent Dominant Lethal Assay | GB 15193.9 |
In Vitro Mammalian Micronucleus Test | GB 15193.28 |
● Toxicity Studies
Test Item | Standard or Guideline |
Subchronic Inhalation Toxicity Study | GB/T 21765/GBZ/T 240.20/OECD413 |
Chronic Oral Toxicity Study | GBZ/T 240.24 |
Chronic Dermal Toxicity Study | GBZ/T 240.25 |
Chronic Inhalation Toxicity Study | GBZ/T 240.26 |
Combined Chronic Toxicity and Carcinogenicity Study | GB/T 21788/GBZ/T 240.28/OECD453 |
Subchronic (90-Day) Oral Toxicity Study in Non-Rodents | GB/T 21778/OECD409 |
Subchronic Inhalation Toxicity Study | GB/T 21787 |
Acute Oral Toxicity: Fixed Dose Procedure | GB/T 21804 |
One-Generation Reproduction Toxicity Study | GB/T 21607/OECD415 |
Two-Generation Reproduction Toxicity Study | GB/T 21758/OECD416 |
Acute Dermal Irritation/Corrosion Test | GB/T 21604/GBZ/T 240.6/OECD404 |
Skin Sensitization Test | GB/T 21608/GBZ/T240.7/OECD406 |
Acute Eye Irritation/Corrosion Test | GB/T 21609/GBZ/T 240.5/OECD40 |
Rodent Dominant Lethal Assay | GBZ/T 240.17 |
Teratogenicity Study | GBZ/T 240.21 |
Carcinogenicity Study | GBZ/T 240.27/OECD451 |
● Mutagenicity Studies
Test Item | Standard or Guideline |
In Vivo Mammalian Erythrocyte Micronucleus Assay | GB/T 21773/GBZ/T 240.11/OECD474 |
Mammalian Spermatogonial Chromosome Aberration Test | GB/T 21751 |
In Vivo Mammalian Hepatocyte Unscheduled DNA Synthesis (UDS) Assay | GB/T 21767 |
In Vitro Mammalian Cell DNA Damage and Repair/Unscheduled DNA Synthesis Assay | GB/T 21768 |
Mammalian Bone Marrow Chromosome Aberration Test | GB/T 21772/OECD475 |
In Vivo Mammalian Bone Marrow Cell Chromosome Aberration Test | GBZ/T 240.12 |
Bacterial Reverse Mutation Test | GB/T 21786/GBZ/T 240.8/OECD471 |
In Vitro Mammalian Cell Gene Mutation Assay | GB/T 21793/GBZ/T 240.10 |
In Vitro Mammalian Cell Chromosome Aberration Test | GB/T 21794/GBZ/T 240.9/OECD473 |
◆ Analytical Chemistry and Clinical Chemistry Testing
Test Item | Standard or Guideline |
Toxicokinetic Study | GB/T 21750/GBZ/T 240.29/OECD417 |
● Core Certifications/Accreditations/Qualifications
Lewwin Pharm Chemical Testing Platform has obtained international OECD GLP Certification, US FDA GLP Certification, AAALAC International Full Accreditation, CNAS and CNCA GLP Certifications (China National Accreditation Service for Conformity Assessment, National Certification and Accreditation Administration), and national CMA accreditation (China Metrology Accreditation), enabling global regulatory submissions.
