|
|
|
Toxicology |
|
First Flight Biosciences is committed to providing in vitro and in vivo toxicology services which support the early drug discovery and lead selection/optimization. In continuation of plate-based efficacy services, First Flight Biosciences provides rapid and valuable safety evaluation to define the potential of new compounds in your pipeline. Client’s compounds will be quickly analyzed for the safety profile in early stage through most our in vitro HTS in vitro toxicology assay as low as 10ul of 10mM.(eg, ~10ul of 10 mM compound can be used for most following in vitro toxicology assays). For further evaluation of compound toxicity, in vivo toxicology study can be initiated and performed in rodents soon in our new SFP level IACUC animal facility.
|
|
In vitro toxicology studies
|
|
We provide robust and rapid in vitro toxicity screening approaches to identify compound liabilities and its STR (structure toxicity relationship) in order to further optimize NCE in an early drug discovery stage. Our fast turnaround results from multiple assays and dose-response profiles help our clients to define the potential toxicity of compounds and assists our clients to select lead compounds with higher probability of success and faster speed. Most of our assays are of high throughput system (eg. 384 plate format) that requires small amounts of tested compound with fast data turnaround (eg. one week).
|
|
|
Genotoxicity
|
|
|
Ames Test
|
|
Micronucleus test (manual / automatic)
|
HTS method available
|
|
|
Cardiac Toxicity
|
|
|
hERGs patch clamp
|
|
hERGs binding assay
|
HTS method available |
|
|
Hepatotoxicity
|
|
|
Hepatocyte cell viability
|
|
Steatosis and phospholipidosis
|
HTS method available |
|
Enzyme induction
|
|
|
Mitochondrial toxicity
|
|
|
Fluorescence-based oxygen consumption assay
|
HTS method available |
|
Membrane potential transition (MPT)
|
HTS method available |
|
|
Cytotoxicity
|
|
|
ATP content assay
|
HTS method available |
|
LDH assay
|
HTS method available |
|
MTT assay
|
HTS method available |
|
Testing will be performed on HepG2 cell line, hepatocyte, astrocytes, neuron cells and other cell lines.
|
|
|
Drug-drug interaction
|
|
|
Human CYP3A4 induction cell based assay
|
HTS method available |
|
Human CYP1A induction cell based assay
|
HTS method available |
|
P-gp inhibition cell based assay
|
HTS method available |
|
|
In vivo toxicology studies
|
|
First Flight Biosciences in vivo toxicology services provide the flexible access to rodents and non-rodent animal species with a variety of administration routes to characterize adverse effects, determine severity and reversibility, to establish a dose-response relationship, to assist in dose selection for clinical trials and to predict genotoxicity. Clinical observation, histopathology, gross pathology, clinical chemistry, hematology and urinalysis will be evaluated in the following study upon your request. First Flight Biosciences owns a new SPF level. AAALAC-compliant animal facility for rodent studies. Non-rodent animal species can be tested in off-site facilities.
|
|
|
Local tolerance test
Dose-range-finding study
Acute toxicity study
Repeat dose study
NOAEL (no observable adverse effect level) determination
In vivo micronucleus testing
Toxicokinetics
|
|
|
In vivo mouse bone marrow micronucleus testing
|
|
|
|