DMPK Services
The BioMetas DMPK team with rich experience and strong credentials provides high-quality, insightful, rapid and cost-effective drug metabolism and pharmacokinetics services for both small molecule compounds (LC-MS/MS analysis method) and large molecule compounds (ELISA analysis method) in multiple fields, and helps client accelerate the research and development (R&D) process, save R&D costs and reduce R&D risks.
- Drug discovery stage
- Pre-clinical research of new chemical entities (NCEs)
- Formulation modification
- Dose ranging finding
- Pre-clinical candidate (PCC) nomination & IND-enabling stage
- Optimization of clinical administration regimen
- Exploratory toxicity assessment
- Evaluation on drug-drug metabolic interactions (DDI)
The BioMetas DMPK team with rich experience and strong credentials provides high-quality, insightful, rapid and cost-effective drug metabolism and pharmacokinetics services for both small molecule compounds (LC-MS/MS analysis method) and large molecule compounds (ELISA analysis method) in multiple fields, and helps client accelerate the research and development (R&D) process, save R&D costs and reduce R&D risks.
- Drug discovery stage
- Pre-clinical research of new chemical entities (NCEs)
- Formulation modification
- Dose ranging finding
- Pre-clinical candidate (PCC) nomination & IND-enabling stage
- Optimization of clinical administration regimen
- Exploratory toxicity assessment
- Evaluation on drug-drug metabolic interactions (DDI)
Our Services
Rodent and Large Animal Study
- Multiple administration routes: PO (solution & mini-capsule/tablet), IV (bolus, infusion), SC, IM, IP, ID, IT, duodenal cannulation, femoral or caudal vein cannulation, etc.
- Proficiency bleeding from rodents: JVC, CAC, PVC, orbital, puncture (saphenous vein, jugular vein, cardiac vein, tail vein, cheek, abdominal aortic vein)
- Skilled collection on multiple biological matrices: blood/plasma/serum, bile/urine/feces,, CSF, bone marrow, spinal cord, lymph nodes, brain (with or without perfusion) and other main tissues
- Superb technology for rat surgery: JVC, CAC, FVC, PVC, BDC, TVC, JVC/PVC, JVC/CAC, etc.
- Pharmacokinetics (PK)/Toxicokinetics (TK)
- IND-enabling studies: single (and 7-day daily) dose PK, tissue distribution and excretion in rats
- Maximum tolerated dose (MTD) and dose ranging finding (DRF) (7-, 14-, 28-day, etc.)
- Non-GLP toxicity (exploratory toxicity)
- Food effect evaluation
- In-life part of large animal study run by partner
Bioanalysis and PK Analysis
- State-of-the-art bioanalytical instrument: API 6500 plus LC-MS/MS system
- Multiple sample processing methods: protein precipitation (PPT); liquid-liquid extraction (LLE), solid phase extraction (SPE), acidification method
- LC-MS/MS based method development for small molecules and peptide molecules, with lowest level of quantitation (LLOQ) in plasma ≤ 1 ng/mL
- Full/partial method validation under US and China FDA guidelines (non-GLP)
- Preclinical PK/TK sample analysis
- PD sample analysis
- Dose formulation analysis (concentration verification, stability and homogeneity)
- PK analysis and PK simulation/prediction using WinNonlin software
- Structural characterization of metabolites (or unknowns) in bio-samples using high resolution mass spectrometry run by partners
Deliverables
- PK/TK parameters
- Bioavailability
- Tissue distribution including blood brain barrier
- Excretion pathways (fecal, urinary, biliary)
- Food effect (dosing under fasted and fed states)
- Formulation selection
- Dose proportionality
- Maximum toleration dose
- Clinical pathology (hematology, clinical chemistry and coagulation) and histopathology
- PK/PD correlation
- PK Simulation/Prediction (allometry human clearance and Vss, human equivalent dose (HED) calculation, dosing regimen simulation/prediction)
- In vivo metabolite pathways
Advantages of the BioMetas Process
