Toxicity testing or safety assessment is a major part of the preclinical safety evaluation related to drug development. Aginko offers safety programs in accordance with guidelines and regulations, ranging from acute to chronic toxicity and carcinogenicity studies.
We also offer a broad range of animal models as well as numerous route of administration.
AGINKO proposes a series of tests for general toxicology assessment. We understand how critical development support is from concept through essential safety and efficacy studies. Toxicologists working with Aginko have experience with a variety of compounds and therapeutic areas. Our staff provides safety services to support analytical and bioanalytical studies for pharmaceutical product development. We are all dedicated to quality and excellence. Our goal is to provide equally reliable data for an accurate and balanced assessment.
In-Vitro Testing
| Test | Based on |
|---|---|
| Mutagenicity test in Bacteria (AMES) | OECD 471, ICH S2(R1) |
| Cytotoxicity test (MTT) | ISO 10993-5 |
| Mammalian Chromosomal aberration | ISO 10993-3 |
| Micronucleus | OECD 487, ISO 10993 |
In-Vivo
| Code | Test | Type of Study | Method | Turnover (Week) | |
|---|---|---|---|---|---|
| AGR1 |
Acute Toxicity (p.o, i.v., i.m., s.c.,i.p., dermal), rodents |
Full study |
|
8 - 10 | |
| AGR2 |
Acute injection toxicity/pathogenicity, rodents
|
Full study | OPTTS 885.3200 | 8-10 | |
| AGR4 |
Acute oral toxicity/ pathogenicity, rodents
|
Full study | OPTTS 885.3300 | 8-12 | |
| AGR5 |
Maximum tolerated dose, rodents
|
Full study (3 - 5 dose levels), clinical and clinical-laboratory observation, gross pathology | CHMP/SWP/302413/08 | 8-12 | |
| AGR6 | Extended single dose toxicity study, rodents |
Full study, clinical and clinical-laboratory observation, gross and histopathology
|
CPMP/ICH/286/95, M3 (R2) | 8-12 | |
| AGR7 | Maximum tolerated dose, non-rodents (rabbits, ferrets, dogs, non-human primates) |
Full study (3 - 5 escalated dose levels), clinical and clinical-laboratory observation, gross pathology
|
CHMP/SWP/302413/08 | 8-12 | |
| AGR8 | Dose range-finding study (p.o, i.v., i.m., s.c.,i.p., dermal), rodents |
2 weeks of administration, 7d/wk exposure, clinical and clinical-laboratory examination, gross pathology, optional histopathology of selected organs
|
CPMP/SWP/1041/99, OPTTS 870-3050 | 8-12 | |
| AGR9 | Dose range finding study (p.o, i.v., i.m., s.c.,i.p.), non-rodents, (rabbits, ferrets, dogs, non-human primates) |
2 weeks of administration, 7d/wk exposure, clinical and clinical-laboratory examination, gross pathology, optional histopathology of selected organs
|
CPMP/SWP/1041/99, OPTTS 870-3050 | 8-12 | |
| AGR10 | 14-21 days repeated dose toxicity study (p.o, i.v., i.m., s.c.,i.p., dermal), rodents |
2 - 3 weeks of administration, 7d/wk exposure, clinical and clinical-laboratory examination, gross pathology, full set of histopathology
|
CPMP/SWP/1041/99, OECD 407, EU B.7, OPTTS 870-3050 | 10-16 | |
| AGR11 | 14-21 days repeated dose toxicity study (p.o, i.v., i.m., s.c.,i.p.), non-rodents, (rabbits, ferrets, dogs, non-human primates) |
2 - 3 weeks of administration, 7d/wk exposure, clinical and clinical-laboratory examination, gross pathology, full set of histopathology
|
CPMP/SWP/1041/99, OECD 407, EU B.7, OPTTS 870-3050 | 10-16 | |
| AGR12 | 28-day repeated dose toxicity study (p.o, i.v., i.m., s.c.,i.p., dermal), rodents, primates) |
7d/wk exposure, clinical and clinical-laboratory examination, functional observation battery, gross pathology, full set of histopathology
|
OECD 407, 410, EU B.7. OPTTS 870-3050 | 18-22 | |
| AGR14 | 28-day repeated dose toxicity study (p.o, i.v., i.m., s.c.,i.p., dermal), non-rodents |
7d/wk exposure, clinical and clinical-laboratory examination, functional observation battery, gross pathology, full set of histopathology
|
OECD 407, 410, EU B.7. OPTTS 870-3050 |
18-22 | |
| AGR16 | 6-month repeated dose toxicity study, rodents |
7d/wk exposure, clinical and clinical-laboratory examination, gross pathology, full set of histopathology
|
OECD 452, CPMP/SWP/1041/99 | 40-42 | |
| AGR17 | 6-month repeated dose toxicity study, non-rodents (rabbits, ferrets, dogs, non-human primates) |
7d/wk exposure, clinical and clinical-laboratory examination, gross pathology, full set of histopathology
|
OECD 452, CPMP/SWP/1041/99 | 40-42 |
We can perform in-vivo studies with diverse administration routes such as:
- Oral: gavage, capsules, dietary admixtures, drinking water
- Parenteral:
- Intravenous: bolus, slow injection, continuous infusion, cycles
(vascular access port)
- Other: subcutaneous, intradermal, intramuscular, intraperitoneal
- Dermal: open, semi-occluded and occluded dressing, patches and other devices, with or without rinsing, with or without collar
- Ocular (including intra-vitreous)
- Intra-nasal
- Inhalation (in non-rodents)
- Intra-vaginal
We have experience in a number of very specific routes of administrations in different species and each study is adapted to the specificity of the product.
At AGINKO we are committed to learn and understand your objectives for your product development in order to meet regulatory requirements. For personalized and adapted toxicology study designs do not hesitate to contact us.
We also conduct studies with very specific adapted designs (adapted to the tested product and specific national regulatory requirements if needed).
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