The traditional method of toxicological evaluation is animal in vivo experiments, through anatomical examination, weighing, calculation of organ index, blood biochemical examination, and pathological morphology examination, etc. For toxicity determination, mainly on rodents and non-rodents conduct. The primary purpose of early drugs in vivo preclinical toxicity testing is to characterize potential side effects and provide an initial estimate of the margin of safety to determine whether a compound is likely to be safe for use in humans. Alfa Chemistry provides professional in vivo toxicological evaluation services to conduct a comprehensive and systematic safety evaluation of generic drugs.
Figure 1. General toxicology workfl ow in early-stage drug discovery. (Fielden MR, et al. 2008)
Our Capabilities
- Localized tolerance testing
- Dose range finding test
- Acute toxicity testing
- Repeat dosing toxicity test
- No adverse effect dose level (NOAEL) determination test
- In vivo micronucleus test
- Toxicokinetic test
Our Services
Alfa Chemistry offers programmatic flexibility for in vivo toxicological evaluation in rodents and non-rodents. We can examine adverse effects by multiple routes of administration, determine the degree of toxicity and reversibility, and establish dose-effect relationships to assist clients in selecting doses for clinical trials and predicting genotoxicity. The following test programs are available upon request:
Common general observations/test contents in early toxicology studies:
| Test Items | Test Content |
| General Clinical Observation | Growth status (feeding, weight change), health status (posture, hair, skin, lid gland, etc.), activity restriction, etc. |
| Blood Biochemistry | Growth status (feeding, weight change), health status (posture, hair, skin, lid gland, etc.), activity restriction, etc. |
| Routine Blood Tests | White blood cell count, lymphocyte count & percentage, monocyte count & percentage, neutrophil count & percentage, red blood cell count, hemoglobin, erythrocyte accumulation pressure, mean erythrocyte volume, mean hemoglobin content & concentration, coefficient of variation of erythrocyte distribution width, platelet count, mean platelet volume, platelet distribution width, platelet pressure accumulation, etc. |
Common tissue crossing (TCR) analyses in early toxicology studies:
| Tissue Name |
| Adrenal gland | Heart | Skin | Bladder |
| Kidney | Spinal cord | Blood | Liver |
| Spleen | Bone marrow | Lungs | Rhabdomyolysis |
| Thyroid | Lymph nodes | Testes | Breast |
| Ovary | Endothelium (blood vessels) | Cerebellum | Cerebellum |
| Cerebellum | Cerebellum | Eye | Prostate |
| Colon | Fallopian tube | Placenta | Uterus (neck) |
| Gastrointestinal tract | Tonsils | - | - |
Our Advantages
- Integration of high-quality in vivo pharmacology research resources
- IND approval in as little as 10 months
- Meet regulatory requirements of FDA, NMPA, EMA, etc.
- Non-clinical safety evaluation
- AAALAC-accredited SPF-rated laboratory animal area
According to customer requirements, we can conduct clinical indication observation, histopathological analysis, gross observation, clinical biochemical analysis, blood test, and urine test in the test project to evaluate the toxicology of generic drugs in vivo. Please contact us for more information.
Reference
- Fielden MR, Kolaja KL. The role of early in vivo toxicity testing in drug discovery toxicology. Expert Opin Drug Saf. 2008 Mar;7(2):107-10.
