Pharmaceutical/Chemical toxicity study

Pharmaceutical/Chemical toxicity study

Leon Biotech Preclinical Safety Toxicology Service addresses the requirements of drug product research and development, and conducts preclinical safety assessment tests according to the regulations of health authorities before clinical trials to prove the safety and toxicology of products. Leon Biotech conducts pharmacological safety toxicology tests according to FDA, OECD and other specifications. With TAF OECD GLP, ISO 17025 certified quality system practices, it provides reliable and stable professional services and planning consulting.

  • Pharmacokinetic/pharmacodynamic modeling*
  • Absorption, distribution, metabolism/catabolism, and elimination (ADME) *
  • Genotoxicity Study
    • OECD 473-In Vitro Mammalian Chromosomal Aberration Test(Alternative with OECD490)
    • OECD 490-In Vitro Mammalian Chromosomal Aberration Test/ Cell Gene Mutation Tests Using the Thymidine Kinase Gene(Alternative with OECD473)
    • OECD 474-Mammalian Erythrocyte Micronucleus Test
  • Toxicology study
    • Acute/LD50 toxicological study
    • Sub-acute repeat dose toxicity study (Oral, Dermal, IV, IP)
    • Sub-Chronic repeat dose toxicity study (Oral, Dermal, IV, IP)
  • Histopathological study service

<Chemical Registration Safety Toxicology Service>
According to the chemical standard registration operation specifications announced by the Chemical Bureau of the Environmental Protection Agency, Leon Biotech provides standard registration toxicology testing services as follows:

Recommend testing method

Standard registration

【OECD TG 420】Acute Oral toxicity-Single dose
【OECD TG 423】Acute Oral toxicity - Acute Toxic Class Method.
【OECD TG 402】Acute Dermal toxicity
【OECD TG 404】Acute Dermal Irriation/ Corrosion
【OECD TG 405】Acute Ocular Irritation/ Corrosion
【OECD TG 406】Skin Sensitization
【OECD TG 429】Skin Sensitisation
【OECD TG 471】Bacterial Reverse Mutation Test
【OECD TG 473】In Vitro Mammalian Chromosomal Aberration Test
【OECD TG 474】Mammalian Erythrocyte Micronucleus Test
【OECD TG 417】Toxicokinetics Book ( Proposal Acceptable)
【OECD TG 408】Repeated Dose 28-Day Oral Toxicity Study in Rodents
【OECD TG 408】Repeated Dose 90-Day Oral Toxicity Study in Rodents
【OECD TG 414】Prenatal Developmental Toxicity Study
【OECD TG 416】 Two-Generation Reproduction Toxicity ( Proposal Acceptable)
【OECD TG 451】Carcinogenicity Study ( Proposal Acceptable)