Safety Evaluation

Nonclinical Safety Evaluation (Non-GLP and GLP)

Service Content  (GLP platfrom built on parent company Boji):

      1、Single dose toxicity test (rodent and non-rodent single dose toxicity test)

            Including median lethal dose (LD50), maximum tolerated dose, etc.

      2、Repetitive dose toxicity test (rodent and non-rodent repetitive dose toxicity test)

            ①  Oral repetitive dose toxicity test

            ②  Intravenous injection (drip) repetitive dose toxicity test

            ③  Percutem repetitive dose toxicity test

            ④  Repetitive dose toxicity test by other route of medication (inhalation, subcutaneous injection, intraperitoneal implantation, etc.)

      3、Safety pharmacology test (general pharmacology test)

      1)Core combination test

            ①  Effect test of test substanceon cardiovascular system and respiratory system of anesthetized animals

            ②  Effect test of test substanceon spontaneous activity of mice

            ③  Effect test of test substanceon mouse body coordination ability

            ④  Effect test of test substanceon pentobarbital sodium induced mouse sleep test

      2)Additional tests

            ①  Additional tests on the centralnervous system (tests such as learning and memory, convulsions and spinal cordreflex)

            ②  Additional test on the cardiovascular system (blood pressure, heart test, etc.)

            ③  Additional test on the respiratory system (tidal volume, lung resistance, lung compliance, etc.)

      3)Supplementary test

            ①  Supplementary test of the test substance on the digestive system (gastrointestinal motility and gastrointestinal function test, bile excretion test, in vitro intestinal tubetest, etc.)

            ②  Supplementary test of test substance on urinary system (urine composition, renal tubular excretion, glomerular filtration rate, etc.)

            ③  Supplementary test of test substance on autonomic nervous system (Effects on contraction of pregnant uterus and non-pregnant uterus, etc.)

      4、Genetic toxicity test

            ①  Micronucleus test in mammals

            ②  In vitro mammalian cell chromosome aberration test

            ③  Salmonella typhimurium reverse mutation test (Ames test)

      5、Reproductive toxicity test

            ①  Phase I test, fertility and early embryo developmental toxicity test

            ②  Phase II test, embryo-fetal body toxicity test (teratogenicity test)

            ③  Phase III test, developmental toxicity test before and after birth (perinatal toxicity test)

      6、 Drug toxicokinetics test

            ①  Study on toxicokinetics of single dose toxicity test

            ②  Study on toxicokinetics of repeated drug toxicity test

            ③  Study on toxicokinetics of reproductive toxicity test

            ④  Study on toxicokinetics of genetic toxicity test

      7、  Local toxicity test

           Carry out local toxicity tests on injections, skin medications, eye drops, ear drops, inhalation preparations, mucosal administration (nasal spray, lozenges, suppositories).

      8、  Immunotoxicity (allergic, photoallergic) and / or immunogenicity test

            ①  Active Systemic Anaphylaxis Test in guinea Pig (ASA)

            ②  Passive Systemic Anaphylaxis Test (PCA) in rats and guinea pigs

            ③  Guinea Pig Buehler Skin Allergy Test (BT)

            ④  Guinea Pig Maximization Test(GMPT)

            ⑤  Active Skin Allergic Test (ACA)

            ⑥  Skin Photoallergic Test

            ⑦  Local Lymph Node Test

            ⑧  Splenic lymphocyte Transformation test

            ⑨  Select other relevant tests according to the characteristics of the test substance