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ˇ@To guarantee safety for human lives and health, it is required that clinical trials are carried out for newly developed pharmaceuticals. With this in mind, It is essential to conduct a series of pre-clinical safety evaluations in order to prove new medicines' safety and effectiveness.
ˇ@Green Seasons' pre-clinical safety evaluations and drug validations are certified by the Chinese National Laboratory Accreditation (CNLA) and are in compliance with other relevant international rules and regulations as well as non-clinical GLP (Good Laboratory Practice) for drugs. Moreover, the company's proposal design, experiment procedures, and report quality are conformable to relevant international standards and major inspection authorities' requirements.
ˇ@During research and development of new drugs and Chinese herbal medicines, it is beneficial to companies in terms of cost effectiveness and smooth product launches if an experienced and reputable internationally renowned CRO gets involved in the process. Because Green Seasons has an excellent team of professionals, internationally recognized field experts, and strategic alliances with Japanese and US companies, the company can assure its clients of the most efficient and professional services during the selection phase of candidate drugs.
Experiments and Services Designed for Pharmaceutical Products and Chinese Herbal Medicines by Green Seasons:
Mammalian Toxicology:
ˇ@Currently, t oxicological pathology tests for mammals are designed based on relevant international rules and regulations, product characteristics, expert consultants' recommendations, and clients' demands. Green Seasons' experiments focus on exploring the toxicological pathological characteristics of a given product while ensuring demands from client companies and inspection authorities are met. In addition, Green Seasons' internationally certified pathologists and quality assurance team work together to meet international standards in various clinical symptom observations, gross or anatomical pathology , h istopathology, and clinical pathology experimentation. In the meantime, Green Seasons' experiment procedures, equipment, and environment conditions comply with GLP standards (safety standard for pharmaceutical products' non-clinical experiments) in execution, standards reinforcement, and inspections.
Single dose Toxicity Study:
Animal: Rats, Mice, Rabbits, Guinea Pig...etc.
Administration Route : oral ˇA i.v. bolus ˇA i.v. infusion ˇA dermal ˇA i.m. ˇA i.p. ˇA s.c. ˇA i.d. |
Acute toxicity limit Study |
Animal ˇG rodents, total two groups ˇ] a test group and a control group ˇ^ , twelve animals per group, six female and six male animals
After signal dosing, to observe animals for fourteen days, and perform the clinical observation, body weights and food consumption measurement. |
Acute toxicity
Studyˇ] LD50 ˇ^
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Animal ˇG rodents, total four groups ˇ] three test groups and one control group ˇ^ , twelve animals per group, six female and six male animals
After signal dosing, to observe animals for fourteen days, and perform the clinical observation, body weights, and food consumption measurement. |
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| Local
Irritation |
Skin irritation Study |
Animal ˇG New Zealand white rabbit, total two groups ˇ] a test group and a control group ˇ^ , three animals per group of either sex
Based on ˇ§Grading system for skin reactionˇ¨, the dermal reactions at the treated areas are observed and recorded at the time points of 1 st , 24 th ,48 th and 72 nd h after the removal of the test article extract and control solution. |
Skin sensitization Study (Maximization Test and Buehler Test)
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Animal ˇG Guinea pig, signal sex, total two groups ˇ] a test group and one or two control group ˇ^ , five animals or ten animals per group
The skin response is graded and evaluated 24 and 48 h after challenge phase by based on ˇ§Grading system for skin reactions. |
| Eye irritation Study |
Animal ˇG New Zealand white rabbit, signal sex, three animals per study
The assessment of eye irritation is evaluated at 1, 24, 48 and 72 h after administration of test article. The evaluation criteria of eye irritation is based on ˇ§System for grading ocular lesionsˇ¨. |
Penis irritation study |
Animal ˇG Guinea pigs or Albino rabbits , male, total two groups ˇ] a test group and a control group ˇ^ , five animals per group
The skin response is graded and evaluated 24 and 48 h after treatment by using ˇ§Grading system for microscopic examination for oral, penile, rectal and vaginal tissue reactionˇ¨. |
Vagina irritation study |
Animal ˇG Guinea pigs or Albino rabbits , female, total two groups ˇ] a test group and a control group ˇ^ , five animals per group
The skin response is graded and evaluated 24 and 48 h after challenge phase by using ˇ§Grading system for microscopic examination for oral, penile, rectal and vaginal tissue reactionˇ¨. |
| Oral cavity study |
Animal ˇG Syrian hamsters, signal sex, total two groups ˇ] a test group and a control group ˇ^ , five animals per group
The skin response is graded and evaluated 24 and 48 h after challenge phase by using ˇ§Grading system for microscopic examination for oral, penile, rectal and vaginal tissue reactionˇ¨. |
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| Repeated dose Toxicity Study |
14-day Subacute Toxicity Study |
Purpose: To clarify the potential toxicity on mammal animals after repeated exposure of test article and to determine NOAEL (No Observable Adverse Effect Level). Animals and dose groups: Rodent; at least 4 groups (3 dose groups plus a control group) and no less than 10 of each sex in each group, Non-rodent; at least 4 of each sex in each group. Administration period: 7 days a week for 14 days. Examination items: Clinical sign, body weight, food consumption, gross observation, clinical pathological analysis (urinal analysis, hematology and blood biochemistry) and histopathology etc.
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28-day Subacute Toxicity Study |
Purpose: To clarify the potential toxicity on mammal animals after repeated exposure of test article and to determine NOAEL (No Observable Adverse Effect Level). Animals and dose groups: Rodent; at least 4 groups (3 dose groups plus a control group) and no less than 10 of each sex in each group, Non-rodent; at least 4 of each sex in each group. Administration period: 7 days a week for 28 days. Examination items: Clinical sign, body weight, food consumption, gross observation, clinical pathological analysis (urinal analysis, hematology and blood biochemistry) and histopathology etc.
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| 90-day Subchronic Toxicity Study |
Purpose: To clarify the potential toxicity on mammal animals after repeated exposure of test article and to determine NOAEL (No Observable Adverse Effect Level). Animals and dose groups: Rodent; at least 4 groups (3 dose groups plus a control group) and no less than 20 of each sex in each group, Non-rodent; at least 4 of each sex in each group. Administration period: 7 days a week for 14 days. Examination items: Clinical sign, body weight, food consumption, gross observation, clinical pathological analysis (urinal analysis, hematology and blood biochemistry) and histopathology etc.
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180-day Chronic Toxicity Study |
Purpose: To clarify the potential toxicity on mammal animals after repeated exposure of test article and to determine NOAEL (No Observable Adverse Effect Level). Animals and dose groups: Rodent; at least 4 groups (3 dose groups plus a control group) and no less than 30 of each sex in each group, Non-rodent; at least 4 of each sex in each group. Administration period: 7 days a week for 14 days. Examination items: Clinical sign, body weight, food consumption, gross observation, clinical pathological analysis (urinal analysis, hematology and blood biochemistry) and histopathology etc.
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| Toxicity of Reproduction |
Embriotoxicity Study |
Purpose: To investigate the functional effects on fertility and early embryonic development. Animals and dose groups: Rodent, at least 4 groups (3 dose groups plus a control group) and no less than 20 of each sex in each group. Administration period: Premating treatment interval of 2 weeks for females and at least 4 weeks for males. Treatment continue throughout mating to termination of males (ensuring the successful copulation) and at least through implantation for females. Examination items: Clinical sign, body weight, food consumption, gross observation, count corpora lutea, numbers of live and dead implantations, individual fetal body weight, etc.
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Teratogenicity Study |
Purpose: To detect adverse effects on pregnant females and fetal development in the period of major organogenesis. Animals and dose groups: Rodent; at least 4 groups (3 dose groups plus a control group), no less than 20 pregnant females in each group. Rabbits; no less than 10 pregnant females in each group. Administration period: Extending from implantation to the end of organogenesis. Examination items: Clinical sign, body weight, food consumption, gross observation, count corpora lutea, numbers of live and dead implantations, individual fetal body weight, abnormalities of fetus including external, visceral and skeleton examination etc.
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Perinatal Toxicity Study |
Purpose: To test for the toxic effect on pregnant/lactating females and on development of the offsprings. Animals and dose groups: Rodent; at least 4 groups (3 dose groups plus a control group), no less than 20 pregnant females in each group. Administration period: From late stage of organogenesis to the end of lactation. Examination items: Examination items: Clinical sign, body weight, food consumption, duration of pregnancy, parturition, gross observation, count corpora lutea, numbers of live and dead implantations, individual fetal body weight, abnormalities of offspring, survival at weaning etc.
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| Carcinogenicity Study
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Dose Range Study |
Purpose: To determine the range of long term study on carcinogenicity. Consisting of the studies as follows: a): Single dose toxicity study. b): Repeated dose toxicity study including subacute toxicity study, subchronic toxicity and chronic toxicity. |
Long Term Carcinogenicity Study |
Purpose: To clarify the carcinogenicity of the test article administrated through animal's life span. Animals and dose groups: 2 strains of rodents, at least 4 groups (3 dose groups plus a control group) and no less than 50 of each sex in each group. Administration period: 7 days a week for 24 months to rat and 18 months to mice, totally, the duration is less than 30 months for rat and 24 months for mice, including the withdrawal period of 1-3 months. Examination items: Examination items: Clinical sign, body weight, food consumption, gross observation, clinical pathological analysis (urinal analysis, hematology and blood biochemistry) and histopathology etc. |
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Genetic Toxicology:
ˇ@Genetic toxicology tests are also designed based on the relevant international rules and regulations, product characteristics, expert consultants' recommendations, and clients' demands. Green Seasons' experiments focus on exploring the toxicological pathological characteristics of a given product while ensuring demands from client companies and inspection authorities are met. In addition, Green Seasons' internationally certified pathologists and quality assurance team work together to meet international standards in various clinical symptom observations, gross or anatomical pathology , h istopathology, and clinical pathology experimentation. In addition, Green Seasons' experiment procedures, equipment, and environment conditions comply with GLP standards (safety standard for pharmaceutical products' non-clinical experiments) for execution, standards reinforcement, and inspections.
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Salmonella reverse mutation test |
Mutant Salmonella strains possess mutant gene character on histidine requirement. Histidine need to be supplied for growth due to its inability to synthesis histidine by itsely. When mutagen stimulate mutant Salmonella , they will reverse from autotroph to auxoautotroph. The test system is used to check the direct or indirect gene variation and variation level to microbacteria by Salmonella reverse mutation test ˇ] Ames test ˇ^ .
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In vitro mammalian chromosomal aberration test |
According to the definition of chromosomal aberration on genetics, chromosomal aberration includes changes on chromosomal structure and number. When cells are harmed, chromosomal numbers may be increased or decreased. Therefore, chromosomal structures may result in the following types of variation ˇG gap, break, exchange, deletion, duplication, and ring. The test system is used to check the direct or indirect chromosome aberration and harmful level by in vitro mammalian chromosomal aberration in culture test.
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Micronucleas test in peripheral blood of rodents |
The test system is used to check the direct or indirect erythrocyte chromosome or mitosis apparatus gene aberration and harmful level by in vivo micronuclei in peripheral blood of rodents.
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| Drug Activity Screening |
Evaluation study of anti-tumor drugs in modulation of cell activity.
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Assessing the potency of anti-tumor drugs in vivo to understand the influence of anti-tumor drugs on tumor cells of human or animals or tumors induced by chemicals.
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Study of drugs in modulation of blood pressure ˇ] rats or mice ˇ^
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Animals with hypertension (disease animal model) are used to assess the potency of drugs in modulation of blood pressure in vivo .
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| Study of drugs in modulation of blood pressureˇ] Canines ˇ^ |
Canines are induced to be hypertensive in blood pressure by surgery or special diet feeding for assessing the potency of drugs in modulation of blood pressure in vivo .
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Study of drugs in modulation of blood sugar ˇ] disease animal model ˇ^ |
Disease animal model or animals with hyperglycemia by chemical induction are used for assessing the potency of drugs in modulation of blood sugar in vivo .
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Study of drugs in modulation of blood sugar ˇ] Insulin assay ˇG Rabbit blood sugar method-quantitative ˇ^ |
Rabbits ˇ] compare to insulin ˇ^ are used for assessing the potency of drugs in modulation of blood sugar in vivo . |
Study of memory hindrance improvement
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Utilizing rats with memory hindrance to assess the potency of drugs in improvement of memory hindrance.
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Study of intelligence improvement
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R ats were used to evaluate potency of the drugs intelligence improvement.
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Evaluation study of drugs in modulation of oral cavity ulcer treatment.
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Oral activity ulcer is induced in hamsters for assessing potency of drugs in oral cavity ulcer treatment.
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Evaluation study of drugs in modulation of cardiovascular diseases .
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Rats, mice or rabbits are induced with cardiovascular diseases to assess the potency of drugs in cardiovascular diseases treatment.
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Evaluation study of drugs in modulation of cell activity. |
Using different cell lines to assess the in vitro cell activity in order to understand the influence of drugs (enhancement or depression).
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Mice with leucocyte deficiency |
Mice is chemically induced to be of leucocyte deficiency for assessing the potency of drugs in modulation of hematopoiesis activity in vivo .
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Evaluation study of drugs in modulation of hair growth. |
Mice are chemically treated to be with hair loss to assess the potency of drugs in modulation of hair growth.
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Evaluation study of drugs in modulation of wound and scalding recovery |
Utiliz ing rats with wound and scalding to assess the potency of the drugs in recover wound and scalding.
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Study of drugs in modulation of immune cell activity in vitro |
Different immune cell lines ˇ] depends on experimental purpose and request ˇ^ are used to assess the potency of drugs in modulation of immune cell activity in vitro .
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Projects Planning
ˇ@Since its founding, Green Seasons has been involved in developing many highly successful products. Through the company's past successes, Green Seasons expects to provide services for companies in closely related industries throughout the R&D, production, and marketing phases. Moreover, through R&D collaborations to craft client companies' strategic directions for product development and positioning, the client company will not only be able to cut costs in R&D, but also speed up product launch and profit earning.
Technical and Regulatory Consulting
ˇ@Green Seasons' law team has a solid background in both domestic and international pre-clinical contracts, and successful past involvements in R&D and product positioning for Chinese herbal medicines. The company has maintained a close relationship with inspection and registration agencies and is kept very well informed of domestic and international rules and regulations. Green Seasons continually monitors market information to assist in the development phase of new pharmaceutical products and Chinese herbal medicines and works to come up with enterprise strategies which best fit the company, effectively reduce development schedule times, cut costs on new medicine development and phase out product release schedules for the company's overall development and planning.
Regulations
ICH: International Conference on
Harmonization
OECD: Organisation for Economic Co-operation
and Development
FDA: Food and Drug Administration
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