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Drug Safety Testing Product List

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INA NOTES June 2016 No.3

INA NOTES June 2016 No.3

Publication of initiatives on animal welfare and alternative methods, as well as reports from the Japanese Society for Regenerative Medicine conference.

"INA NOTES June 2016 No.3" is a publication by Inari Research Co., Ltd., which conducts safety testing and efficacy pharmacology testing for the development of pharmaceuticals, medical devices, pesticides, food, and other chemical substances. This publication includes a report on participation in the 15th Annual Meeting of the Japanese Society for Regenerative Medicine, as well as research presentation reports from the 7th Annual Meeting of the Japanese Society for Safety Research, and information on the marmoset testing project, accompanied by graphs and photographs. [Contents] ■ Efforts towards animal welfare and alternative methods ■ Participation report: 15th Annual Meeting of the Japanese Society for Regenerative Medicine ■ Research presentation report: 7th Annual Meeting of the Japanese Society for Safety Research ■ Marmoset testing project for small primates - Report No. 3 - ■ Recent events, etc. *The downloadable version is a "digest version." If you would like the "full version," please feel free to contact us.

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Safety testing of pharmaceuticals: "Reproductive and developmental toxicity testing"

Safety testing of pharmaceuticals: "Reproductive and developmental toxicity testing"

Top-class achievements in the country with abundant background data!

Inari Research's reproductive and developmental toxicity testing boasts top-class achievements in Japan, backed by reliable technology and extensive background data. Even in reproductive tests where stress on the mother animal directly affects the evaluation, we continue to collect stable data through various administration routes such as oral, intravenous, subcutaneous, and transdermal. Certified reproductive and developmental toxicity specialists support the testing from design to evaluation. 【Main Types of Tests】 ■ Tests that encompass all reproductive and developmental processes as outlined in ICH guidelines are possible: - Tests related to fertility and early embryonic development up to implantation (mice, rats) - Tests concerning prenatal and postnatal development as well as the functions of the mother animal (rats) - Tests related to embryonic and fetal development (mice, rats, rabbits) - Single tests (rats) *For more details, please refer to the PDF materials or feel free to contact us.

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Safety testing of pharmaceuticals: Analysis of test substances

Safety testing of pharmaceuticals: Analysis of test substances

For analysis of safety tests, turn to Inari Research with its extensive experience and track record!

At Inari Research, we conduct analyses of test substances and dosing solutions used in safety testing. GLP-compliant implementation is possible. We also have a track record of analyses in multi-site studies. 【Analysis of Test Substances】 ■ Method validation ■ Concentration verification, uniformity, stability, and characterization analysis 【Regarding Concentration Verification, Uniformity, Stability, and Characterization Analysis】 ■ Concentration verification and stability/uniformity testing of dosing solutions - Using HPLC, spectrophotometers, ELISA kits, etc. ■ Characterization analysis and stability of test substances (active ingredients and formulations) - Using HPLC, TLC, spectrophotometers, pH meters, Karl Fischer moisture meters, osmotic pressure meters, etc. *For more details, please refer to the PDF document or feel free to contact us.

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General Toxicity Test for Pharmaceutical Safety Evaluation

General Toxicity Test for Pharmaceutical Safety Evaluation

Support for toxicity testing from the screening stage to entering clinical trials!

Inari Research supports toxicity testing from the screening stage until entering clinical trials (clinical studies). We conduct a wide range of tests based on our extensive testing experience and accumulated background data in standard test systems such as mice, rats, rabbits, dogs, and of course, monkeys. The tests are conducted in a GLP-compliant facility that has obtained certification from AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). We can complete a series of non-clinical test sets, including genotoxicity tests and safety pharmacology tests necessary to enter clinical trials (Phase I), with the final report preparation finished within six months. 【Main Types of Tests】 ■ Single-dose tests ■ Expanded single-dose toxicity tests ■ Repeated dose tests for 2 weeks, 4 weeks (1 month), 13 weeks (3 months), 26 weeks (6 months), 39 weeks (9 months), and 52 weeks (12 months) ■ Various dose-setting tests ■ General toxicity tests in the drug discovery exploration stage, etc. *For more details, please refer to the PDF document or feel free to contact us.

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INA NOTES June 2017 No.5

INA NOTES June 2017 No.5

Features on international trends in animal welfare and initiatives related to marmoset testing projects.

"INA NOTES December 2017 No.5" is a publication by Inari Research Co., Ltd., which conducts safety testing and pharmacological efficacy testing for the development of pharmaceuticals, medical devices, pesticides, food, and other chemical substances. This publication features the latest technological information, a special section on drug dependency testing, and initiatives related to the marmoset testing project, along with diagrams and photographs. [Contents] ■ SEND Reports: Initiatives for SEND by pathologists ■ Series: Initiatives of the marmoset testing project ■ Special Feature: AAALAC International Site visit and international trends in animal welfare ■ Conference participation report ■ TOPICS ■ Announcements *For more details, please refer to the PDF document or feel free to contact us.

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Safety testing of pharmaceuticals: Tests using young animals.

Safety testing of pharmaceuticals: Tests using young animals.

Support for single and repeated dose toxicity tests using young animals with a wealth of experience!

Inari Research supports toxicity testing from the screening stage until entering clinical trials (clinical studies). We conduct a wide range of tests based on our extensive testing experience and accumulated background data in standard test species such as mice, rats, rabbits, dogs, and of course, monkeys. The tests are conducted in a GLP-compliant facility that has obtained certification from AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). A series of non-clinical test sets, including genotoxicity tests and safety pharmacology tests necessary to enter clinical trials (Phase I), can be completed with the final report prepared within six months. [Test using young animals] ■Animal species: Rats, Dogs ■Administration timing: - Young rats can be administered orally, intravenously, or subcutaneously from day 4 of age; transdermal administration is possible from day 23 onwards. - Young dogs can start administration from 3 weeks of age. ■Routes of administration: Oral, intravenous, subcutaneous, transdermal *For more details, please refer to the PDF materials or feel free to contact us.

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Safety testing of pharmaceuticals: "Genotoxicity testing"

Safety testing of pharmaceuticals: "Genotoxicity testing"

We offer tests tailored to your needs, from screening tests to application tests!

Inari Research supports toxicity testing from the screening phase to the entry into clinical trials (clinical studies). In addition to application tests in accordance with guidelines, our staff, who have extensive experience and achievements, will also handle screening tests. We conduct our tests at a GLP-compliant facility that has obtained certification from AAALAC International (the Association for Assessment and Accreditation of Laboratory Animal Care International). A series of non-clinical test sets, including genotoxicity tests and safety pharmacology tests necessary to enter clinical trials (Phase I), can be completed with the final report prepared within six months. 【Genotoxicity Tests】 ■ Reverse mutation test (Ames test) ■ In vitro / in vivo chromosome aberration tests ■ In vitro / in vivo micronucleus tests ■ Phototoxicity tests (3T3 cells) ■ In vivo comet assay *For more details, please refer to the PDF materials or feel free to contact us.

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"Safety Testing of Pharmaceuticals Using Marmosets" *Presentation materials for the conference are provided.

"Safety Testing of Pharmaceuticals Using Marmosets" *Presentation materials for the conference are provided.

Detection of human-like responses with a small amount of test substance. Successful development of a new CPP test.

Our company conducts "safety testing of pharmaceuticals using marmosets," which allows for the efficient acquisition of non-clinical data. Marmosets are small primates weighing between 250 to 500 grams, providing the following advantages for conducting tests, such as requiring smaller amounts of test substances. 【Features】 ◎ Compared to cynomolgus monkeys, valuable test substances are needed in smaller quantities (about 1/10) ◎ Compared to rats and dogs, human-like pharmacological reactivity can be expected ★ Currently, we are compiling and presenting "conference presentation materials" summarizing test data and more. You can view them immediately via the "Download" link.

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Safety testing of pharmaceuticals: General toxicity test using rodents.

Safety testing of pharmaceuticals: General toxicity test using rodents.

Support for toxicity tests from the screening stage to entering clinical trials!

Inari Research supports toxicity testing from the screening stage until entering clinical trials (clinical studies). We conduct a wide range of tests based on extensive testing experience and accumulated background data in standard test species such as mice, rats, rabbits, dogs, and of course, monkeys. Tests are conducted in a GLP-compliant facility that has obtained certification from AAALAC International (the Association for Assessment and Accreditation of Laboratory Animal Care International). A series of non-clinical test sets, including genotoxicity tests and safety pharmacology tests necessary to enter clinical trials (Phase I), can be completed with the final report prepared within six months. 【Tests using rodents】 ■Animal species: Mice, rats, hamsters ■Routes of administration: Oral administration, intravenous administration, intraperitoneal administration, subcutaneous administration, transdermal administration, rectal administration ■Tests are also conducted using 24-hour continuous intravenous infusion in rats. *For more details, please refer to the PDF document or feel free to contact us.

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Safety testing of pharmaceuticals: General toxicity test using rabbits.

Safety testing of pharmaceuticals: General toxicity test using rabbits.

Support for toxicity testing from the screening stage to entering clinical trials!

Inari Research supports toxicity testing from the screening stage until entering clinical trials (clinical studies). We conduct a wide range of tests based on our extensive testing experience and accumulated background data in standard test systems such as mice, rats, rabbits, dogs, and of course, monkeys. The tests are conducted in a GLP-compliant facility that has obtained certification from AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). A series of non-clinical test sets, including genotoxicity tests and safety pharmacology tests necessary to enter clinical trials (Phase I), can be completed with the final report prepared within six months. [Test using rabbits] ■ Routes of administration: oral administration, intravenous administration, ocular administration, intramuscular administration, subcutaneous administration, transdermal administration, rectal administration. *For more details, please refer to the PDF materials or feel free to contact us.

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Safety testing of pharmaceuticals: General toxicity test using cynomolgus monkeys.

Safety testing of pharmaceuticals: General toxicity test using cynomolgus monkeys.

Support for toxicity testing from the screening stage to entering clinical trials!

Inari Research supports toxicity testing from the screening stage until entering clinical trials (clinical studies). We conduct a wide range of tests based on our extensive testing experience and accumulated background data in standard test systems such as mice, rats, rabbits, dogs, and of course, monkeys. Tests are conducted at a GLP-compliant facility that has obtained certification from AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). A series of non-clinical test sets, including genotoxicity tests and safety pharmacology tests necessary to enter clinical trials (Phase I), can be completed with the final report prepared within six months. [Test using cynomolgus monkeys] - Routes of administration: oral administration, intravenous administration, intramuscular administration, topical administration, subcutaneous administration, ocular administration, intraperitoneal administration, rectal administration - Tests can also be conducted with continuous intravenous infusion for 24 hours. *For more details, please refer to the PDF document or feel free to contact us.

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Safety pharmacology core battery tests for pharmaceuticals.

Safety pharmacology core battery tests for pharmaceuticals.

We deliver stable data with high technical expertise!

Inari Research supports toxicity testing from the screening phase to the entry into clinical trials (clinical studies). We conduct a wide range of tests based on our extensive testing experience and accumulated background data using standard test subjects such as mice, rats, dogs, and of course, monkeys. Safety pharmacology tests are conducted in accordance with guidelines. GLP compliance is available. Our knowledgeable staff ensures stable data delivery. Measurements during intravenous injections are also possible. 【Safety Pharmacology Core Battery Tests】 ■ Central Nervous System - FOB (Rats, Dogs, Monkeys) - Irwin Method (Mice) ■ Cardiovascular System - Telemetry tests using unanesthetized animals (Dogs, Monkeys) - hERG (HEK293, CHO) Other tests, such as measurements with Holter electrocardiograms, can be conducted under various conditions including unrestrained/restrained and unanesthetized/anesthetized, according to your requests. ■ Respiratory System - Measurement of respiratory rate, tidal volume, and minute ventilation (unanesthetized/unrestrained rats) - Blood gas measurements (unanesthetized dogs/monkeys) *For more details, please refer to the PDF document or feel free to contact us.

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Safety testing of pharmaceuticals: "Immunotoxicity Testing"

Safety testing of pharmaceuticals: "Immunotoxicity Testing"

Support for toxicity testing from the screening stage to entering clinical trials!

Inari Research supports toxicity testing from the screening stage to the entry into clinical trials (clinical studies). We propose test designs tailored to the regulations and drugs of each country. 【Immediate Hypersensitivity Tests】 ■ Active Systemic Anaphylaxis Test (ASA Test) ■ Passive Cutaneous Anaphylaxis Test (PCA Test) ■ Heterologous Passive Cutaneous Anaphylaxis Test (Hetero-PCA Test) 【Delayed-Type Hypersensitivity Tests】 ■ DTH Skin Reaction Test ■ Popliteal Lymph Node Test (PLNA Test) ■ Skin Sensitization Tests - Maximization Method, Adjuvant and Patch Method, Buehler Method, etc. - Local Lymph Node Assay (LLNA Method) ■ Skin Phototoxicity Test *For more details, please refer to the PDF materials or feel free to contact us.

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Safety testing of pharmaceuticals: General toxicity test using dogs.

Safety testing of pharmaceuticals: General toxicity test using dogs.

Support for toxicity testing from the screening stage to entering clinical trials!

Inari Research supports toxicity testing from the screening stage until entering clinical trials (clinical studies). We conduct a wide range of tests based on our extensive testing experience and accumulated background data in standard test species such as mice, rats, rabbits, dogs, and of course, monkeys. Tests are conducted in a GLP-compliant facility that has obtained certification from AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). A series of non-clinical test sets, including genotoxicity tests and safety pharmacology tests necessary to enter clinical trials (Phase I), can be completed with the final report prepared within six months. [Tests using dogs] - Animal species: Beagles from domestic and international breeding sites - Routes of administration: Oral, intravenous, subcutaneous, intramuscular, ocular, transdermal, intra-articular, and rectal administration - Tests can also be conducted using continuous intravenous infusion for 24 hours. *For more details, please refer to the PDF materials or feel free to contact us.

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Safety testing of pharmaceuticals: "Carcinogenicity testing"

Safety testing of pharmaceuticals: "Carcinogenicity testing"

An experienced pathologist will conduct the diagnosis!

Inari Research supports toxicity testing from the screening stage to the entry into clinical trials (clinical studies). We conduct a wide range of tests based on our extensive testing experience and accumulated background data in standard test systems such as mice, rats, rabbits, dogs, and of course, monkeys. Experienced pathologists in carcinogenicity testing perform tumor diagnoses. The results of tumor diagnoses can undergo peer review by pathologists both domestically and internationally. 【Carcinogenicity Testing】 ■ Long-term carcinogenicity tests using mice and rats (preliminary tests, main tests) - Can be conducted via oral (forced, mixed feed), dermal, subcutaneous, and other routes of administration. ■ Short-term carcinogenicity tests - Short-term carcinogenicity tests using genetically modified mice are also possible. *For more details, please refer to the PDF materials or feel free to contact us.

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