Functional service


Using our research capability for DMPK and Bioanalysis, we support acceleration and success of customer's projects from drug discovery to development widely.
In vivo pharmacokinetic studies (parenteral administration)
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■Modeling & simulation
We provide a service for the integrated PK/PD modeling, interpretation of PK, drug effect and biomarker measurement in non-clinical studies. We support translational research through practical pharmacometrics (PMX) activities mainly focus on model based drug development(MDBB).
It is useful in all stages of drug discovery and development, such as compound selection from the discovery stage, proposal of target exposure level at the start of clinical trials, and optimization of dose regimen for clinical POC trials.
We have supported non-clinical and clinical PK/PD modeling of diabetes, antihypertensive, and proton pump inhibitors for approved drugs. We have also successfully analyzed the Biomarker-Efficacy relationship of anticancer drugs and extrapolated to the clinical trials.
The business alliance with Leiden Advanced PK/PD (LAP&P), which is a global leading company in PK/PD field, accelerates the introduction of more advanced PMX services, such as physiologically-based pharmacokinetic analysis (PBPK) and quantitative systems pharmacology (QSP) to accelerate drug development for our clients.
Experienced members of PMX activities support drug discovery and development through practical MDBB. We accept requests as comprehensive consulting for drug discovery and development, not just as a contract for PK / PD analysis.

■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 DMPK

ADME Screening
ADME Screening ▶ Purity
▶ Kinetic solubility
▶ log D
▶ MDR1 substrate screening (using NIH MDR1-MDCK cell)
▶ Metabolic stability
▶ CYP inhibition
▶ CYP3A time-dependent inhibition (TDI)
▶ CYP induction
▶ Plasma protein binding
▶ Cassette dosing (rodents)
Discovery DMPK Studies
Bioanalysis (including method development)
In vitro studies ▶ CYP phenotyping studies
▶ CYP3A time-dependent inhibition (TDI)
▶ CYP induction
▶ Non-CYP metabolism studies
▶ Hepatocyte metabolic clearance
▶ Metabolite structural analysis (in vitro/in vivo)
▶ GSH/CN trapping studies
▶ Blood/plasma concentration ratio
▶ Substrate specificity studies using various transporter-expressing cells
▶ Inhibition studies using various transporter-expressing cells
▶ Plasma protein binding
▶ Skin permeability studies
Pharmacokinetic studies in various animal species ▶ Cassette dosing (non-rodents)
▶ Tissue distribution, urinary/biliary excretion
▶ Parenteral administration (transdermal, intranasal, pulmonary, sublingual, intrarectal, etc.)
Compound optimization / translational research ▶ Structure-property relationship
▶ DDI risk assessment
▶ Human PK, effective concentrations, and effective doses prediction
▶ PK/PD/E analysis, TK/TD analysis, modelling & simulation (Business partnership with Leiden Advanced PK/PD)
Physicochemistry and Preformulation Studies
Physicochemical property profiling ▶ Purity
▶ Crystal form / crystallinity
▶ Thermal property
▶ Hygroscopicity
▶ Particle size
▶ Thermodynamic solubility, etc.
Development form selection
Formulation for animal experiments
Stability (solid, solution, dosing formulation)