Functional service

Safety

Designing and executing in vitro / in vivo toxicology studies from target validation to IND and beyond. Providing reliable data with toxicological interpretation to make GO / No-Go decision.


■Package service for preclinical safety evaluation
Axcelead offer comprehensive support for smooth IND application and out-licensing by using our experience with numerous applications in Japan, the EU and the US and knowledge gained through in-licensing investigation
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■Consulting service  
Axcelead offer consulting on non-clinical development strategy and individual issues in various developmental phases.We provide the best solution by making the best use of our sophisticated technology, wealthy knowledge and experience of IND/NDA.
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◇Service menu for Safety

in vitro Exploratory Safety Studies
Cytotoxicity ▶ Glu/Gal cytotoxicity assay(HepG2 cell)
Phospholipidosis ▶ Phospholipidosis assay(HepG2 cell)
Cardiotoxicity ▶ hERG, Nav1.5 peak, Cav1.2 automated patch clamp
▶ Microelectrode array(MEA)assay(hiPS-cardiomyocytes)
Secondary pharmacology ▶ Promiscuous/diversity panel
Genotoxicity ▶ umu microtest(TA1535/pSK1002)
▶ Ames test(TA100, TA98)
▶ Micro-Ames test(TA100, TA98)
▶ In vitro micronucleus test(TK6 cell)
▶ Micro-Flow(In vitro micronucleus test using Flowcyte(TK6 cell)
▶ Multi-Flow DNA damage assay(γH2AX/pHH3/p53/polyploidy(TK6 cell))
Phototoxicity ▶ UV/Vis absorption spectra
▶ In vitro 3T3 NRU phototoxicity test
In vivo safety studies
Exploratory studies
TK/tolerability studies in rodents and non-rodents
Preliminary range-finding repeated-dose toxicity studies in rodents and non-rodents (including TK studies)
Cardiovascular safety pharmacology study in rodents and non-rodents (including TK studies; possible in conscious or anesthetized condition)  
Preliminary embryo-fetal development toxicity study in rodents and rabbits (including TK studies)
In vivo photo toxicity studies in rodents
In vivo micronucleus tests in rodents
Improvement of oral absorption for insoluble drugs due to nanoparticle preparation technology  
In vivo definitive safety studies for investigational new drug (IND) application*
Repeated-dose toxicity studies in rodents and non-rodents
Safety pharmacology studies
Genotoxicity studies
*: GLP-compliant (including partly subcontract)
In vivo definitive safety studies for new drug application (NDA) *
Reproductive and developmental toxicity studies
Long-term Repeated-dose toxicity studies
Carcinogenicity studies
Juvenile animal toxicity studies in rodents
*: GLP-compliant (including partly subcontract)
Toxicity mechanism studies / Target validation / Efficacy studies
Preliminary toxicity evaluation in pharmacology studies
Characterization of disease models and Tg/KO animals
Neuro-electrophysiological examinations due to compound muscle action potentials (CMAPs) or motor evoked potentials (MEPs) in rodents
Pharmacology studies of regenerative medicines in immunosuppressed animals
Exploratory carcinogenicity/tumorigenicity studies of regenerative medicines in immunodeficient mice
Ocular function evaluation and mechanistic studies of ocular toxicity (ex. quantitative determination of cataract, ERG, cornea histological examination in life and cotton yarn/Schirmer tear test in rodent)
Histology services (Special staining, immunohistochemistry, and in situ hybridization)
Whole slide image analysis / Morphometry (Fibrosis, G-ratio, etc.)
Electron microscopic examinations
Laser capture microdissection
Clinical pathology (Hematology, Blood chemistry, Blood coagulation test, Blood compatibility test, Hemolysis test, Urinalysis)
Exploratory tumorigenesis studies for development of regenerative medicine products
Consulting services
Non-clinical safety consultation in various developmental phases (screening phase, candidate nomination, candidate selection, IND, NDA)
Consultation on issues inquired from the regulatory authorities