9 months to 1.5 years for NCEs (2 years for Biologics)
- In vitro assay
- In vivo pharmacology
- PK/PD/Human PK simulation
- In vitro/in vivo ADME
- Exploratory toxicity
- IND-enabling toxicity
- Process Development/CMC
-
- Screening Model
-
- Short model
- Single read-out
-
- Mechanistic model
-
- Model engaging pathway of interest
- More specific read-outs related to MoA
-
- Disease model
• Acute • Chronic
-
- Optimal efficacious dose
- Combi-therapy
-
In vivo screening models
- Primary cells or cell lines
- Animal/human whole blood
-
ADME profile
- In vitro ADME
- Transporter
-
Cellular pharmacokinetics
-
In vivo pharmacology
- In vivo model
- PK endpoint (plasma/tissue)
-
Screening In vitro toxicity
-
PK/PD studies
- Single dose
- Gender difference
- Food effect
- Biomarker
-
Safety profiles
- Toxicity studies
in rodents and
non-rodents
- Genotoxicity
- Safety pharmacology
기업소개
(주)큐베스트바이오