Toxicology Testing (Non-GLP) Service

Toxicology testing is an essential step in drug development to evaluate the safety of new therapeutic candidates before they advance into clinical trials. These studies help determine toxic dose ranges, identify target organ toxicity, and provide systemic safety and risk assessment to ensure that only compounds with acceptable safety profiles move forward in the pipeline.

Abnova provides non-GLP toxicology testing services, including single dose toxicity studies, repeated dose toxicity studies, and systemic safety and risk assessment. We ensure quality performance, delivery of high-quality data, and proper interpretation, review, and reporting of every aspect of your study, supporting regulatory requirements and the successful advancement of your drug development program.

Advantages

High-quality data output
Fast turnaround times
Compliance with regulatory standards
Flexible animal models
Customizable protocols to suit specific needs

Our Services

Single dose toxicity

- Dose range finding study
- Acute toxicity study
- Subacute toxicity study

Repeated dose toxicity

- Acute toxicity study
- Subacute toxicity study

Systemic safety and risk assessment

Test Items

Hematology
Biochemistry
Histopathology
Cytokine Assay

Examples

Repeated Dose Toxicology Evaluation of Three SD Rat Groups Following Immunotherapy

Hematology Tests

Parameters	Group A (Control)			Group B (Vehicle)			Group C (Test Article)
	Acute Toxicity Study		Subacute Toxicity Study	Acute Toxicity Study		Subacute Toxicity Study	Acute Toxicity Study		Subacute Toxicity Study
	D3	D30	D42 (Recovery)	D3	D30	D42 (Recovery)	D3	D30	D42 (Recovery)
RBC (10⁶/µL)	6.68	7.88	8.30	7.00	8.44	8.04	7.01	8.55	7.88
HGB (g/dL)	12.6	15.0	14.7	13.4	15.5	Vehicle	14.1	15.7	15.2
HCT (%)	37.5	44.4	43.4	40.2	45.7	42.1	41.5	46.1	45.1
MCV (fL)	56.1	56.3	52.3	57.4	54.1	52.4	59.2	53.9	57.2
MCH (pg)	18.9	19.0	17.7	19.1	18.4	17.9	20.1	18.4	19.3
MCHC (g/dL)	33.6	33.8	33.9	33.3	33.9	34.2	34.0	34.1	33.7
RDW-SD (fL)	24.5	26.0	24.7	24.3	26.2	24.0	24.3	26.8	26.6
RDW-CV (fL)	13.3	16.7	17.4	14.4	17.8	16.2	12.6	19.0	16.1
RET (%)	5.08	3.92	3.79	5.72	2.36	2.88	4.01	3.02	2.69
PLT (10³/µL)	690	706	919	962	742	873	623	821	950
PDW (fL)	8.6	9.6	8.9	8.0	8.2	8.3	8.3	8.2	8.1
WBC (10³/µL)	9.67	9.99	5.32	12.62	7.23	5.86	14.12	9.14	10.31
NEU (%)	2.7	5.0	7.4	4.1	7.1	7.6	3.6	14.2	13.3
LYM (%)	93.4	92.0	88.2	91.0	82.3	88.7	93.1	80.0	84.2
MON (%)	2.8	1.2	2.1	3.7	8.7	1.5	2.5	4.3	1.0
EOS (%)	1.1	1.5	2.1	1.0	1.8	1.9	0.7	1.4	1.4
BAS (%)	0	0.3	0.2	0.2	0.1	0.3	0.1	0.1	0.1

Biochemistry Tests

Parameters	Group A (Control)		Group B (Vehicle)		Group C (Test Article)
	Acute Toxicity Study	Subacute Toxicity Study	Acute Toxicity Study	Subacute Toxicity Study	Acute Toxicity Study	Subacute Toxicity Study
	D30	D42 (Recovery)	D30	D42 (Recovery)	D30	D42 (Recovery)
GLU (mg/dL)	289	292	153	374	253	163
TG (mg/dL)	85	80	88	63	80	76
CHOL (mg/dL)	43	43	116	48	60	71
GGT (U/L)	1	1	1	1	1	1
AST (U/L)	117	128	138	190	123	127
ALT (U/L)	38	50	42	63	41	49
TP (g/dL)	5.5	6.6	6.8	5.8	6.1	6.9
ALB (g/dL)	3.09	3.92	3.82	3.42	3.52	3.87
TBIL (mg/dL)	0.1	0.1	0.1	0.1	0.1	0.1
CK (U/L)	589	973	630	4690	1401	554
BUN (mg/dL)	28.1	26.9	23.3	30.5	27.1	27.8
CREA (mg/dL)	0.56	0.46	0.46	0.89	0.46	0.46
AMY (U/L)	377	510	552	515	406	526
A/G	1.3	1.5	1.3	1.5	1.4	1.3
GLO (g/dL)	2.4	2.7	3.0	2.3	2.6	3.1
ALP (U/L)	113	92	114	67	96	160
Ca (mg/dL)	9.8	10.0	10.3	10.4	9.8	10.1
Cl (mmol/L)	104	101	100	98	101	101
P (mg/dL)	6.8	8.7	5.5	19.4	6.6	6.5
K (mmol/L)	4.7	4.0	4.4	6.1	4.2	4.4
Na (mmol/L)	144	143	144	141	141	144

Histopathology Tests

Subacute Toxicity Study	Acute Toxicity Study
Group A (Control), 42 days	Group B (Vehicle), 30 days	Group C (Test Article), 30 days

H&E staining, 100X. 42 days, infiltration, histiocytic cell, focal, minimal, lung.	H&E staining, 100X. 30 days, infiltration, histiocytic cell, focal, minimal, lung.	H&E staining, 100X. 30 days, infiltration, mononuclear cell, focal, minimal, lung.

Cytokine Assays

Toxicology_Testing_Service_4.jpg (209 KB)

Group	Group A (Control)		Group B (Vehicle)		Group C (Test Article)
	Acute Toxicity Study		Acute Toxicity Study		Acute Toxicity Study
	D0	D3	D0	D3	D0	D3
IL12 (pg/ml)	350	539	122	1136	330	176

Toxicology_Testing_Service_5.jpg (229 KB)

Group	Group A (Control)		Group B (Vehicle)		Group C (Test Article)
	Acute Toxicity Study		Acute Toxicity Study		Acute Toxicity Study
	D0	D3	D0	D3	D0	D3
IFN-γ (pg/ml)	N.D.	N.D.	N.D.	N.D.	N.D.	N.D.

N.D. means that the limit of detection of this assay is lower than 31.25 pg/mL.

oem@abnova.com
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