Aginko
Toxicity Testing

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 cardiogenecity 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 the 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 aqually 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

OECD 420, 423, 425, 402, EU B.1.tris, ,  EU B.1bis, EU B.3, OPTTS 870-1200

 
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)
    • Others: 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 regulatories 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).

To read more about Toxicity Testing,
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AGINKO Research AG
AGINKO Research AG, Route de l'ancienne Papeterie 7
1723 Marly , Switzerland