DMPK
Service Introduction
In-Vivo PK
Species
Rat: SD, Wistar
Mouse: CD1, C57BL/6, BALB/c
Dog: Beijing Marshall Beagle Dog
Monkey: Cynomolgus Monkey
Guinea Pig
Rabbit
Types of Study
Excretion Study PK comparison for Formulations and vehicle screening
Dose Escalation Trials
Tissue Distribution
Bioavailability
Non-GLP Toxicological Study
Surgical Techniques
Jugular Vein Cannulation
Thoracic Duct Cannulation
Bile Duct Cannulation
Portal Vein
Duodenum Cannulation
Lymphatic Cannulation etc.
Dosing Routes
Intravenous, Oral, Intraperitoneal, Subcutaneous
ICV, Intradermal, Intramuscular, Transdermal
Portal Vein, Intestinal, Mini-pump, Intravitreal Injection
Ocular Instillation, Sublingual, Inhalation, Intratympanic
Intravaginal, Intraarticular, Intranasal, Intratracheal
Types of Study Molecule
Small Molecule Drugs
Biologics
Gene Therapy Drugs
Cell Therapy
In-Vitro ADME
Absorption
Permeability:PAMPA,Caco-2,MDCK-MDR1,Membranevesicle
Transporters: OATP1B1/3, OAT1/3, OCT2, MDRs, BCRPPhysicochemical Properties Analysis: KS/TS, log D / log P
Distribution
Plasma/Serum/Tissue Protein Binding, etc.
Blood to Plasma Ratio
Metabolism & Excretion
Matrix Stability: Plasma, Blood, Tissue, Simulated Intestinal Fluid and Gastric Fluid, Buffe
Metabolic Stability: Hepatocytes, Microsomes, S9 of Different SpeciesMetabolite Identification: Structural Identification and Quantitative Testing
Drug-Drug Interaction
CYP Inhibition (Reversible and Time Dependent)
CYP Induction CYP Phenotyping
Transporters (Uptake and Inhibition)
Innovative Biopharmaceutical and Biosimilars PK
Molecular Type
Peptides
Monoclonal Antibodies
Bispecific Antibodies
Antibody Drug Conjugates
Oligonucleotides
Immunogenicity
Anti-Drug Antibody (ADA)
Neutralizing Antibody
Biomarker Analysis Platform
ELISA、MSD 、
Luminex、 qPCR、
FACS Analysis、LC/MS/MS
Biomarker
Fit-for-Purpose Exploratory Biomarkers to Support Safety and Efficacy
IND Application Service
Our DMPK team works closely with CMC, Regulatory Bioanalysis Clinical teams and expert consultant to ensure In-depth interpretation of ADME / PK data and give full clinical.
We provide IND-enabling ADME, biotransformation and in vivo PK studies services to support IND filing, in full compliance with international regulatory requirements.
Target validation
Lead compounds
Lead compound optimization
Candidate compounds PCC
IND Application
Clinic
Definitive
DDI
IND Enabling
ADME
In-Vitro and In-VivoMet ID
In-Vivo
PK
PK/PD
Assessment
DMPK Study Design and Dossier Preparation
Human PK Projection
Experimental Instruments
- LC-MS/MS：API6500plus、 API6500、API5000、API4000，etc
- Flow cytometry
- PCR(q-PCR)
- High-resolution mass spectrometer,Thermo QE
- Eppendorf 5810R
- Beckman MAX-XP
- Eppendorf 2.5、10、100、200、1000、5000μL
Quality System
· Passed the inspection and quarantine
· Regular animal medical examination
· Suppliers with relevant qualifications
· Regular third-party inspection of experimental animals
· Regular water quality testing
· Daily cleaning and disinfection
· The facility environment is up to standard
· Provide quality test report for each batch
· The entry and exit of people and goods are strictly controlled
Our Strength
Resources of experimental animals (cynomolgus monkeys, beagles, etc.)
Experience in both Chinese and American IND applications
Small/large molecule detection and analysis ability
PK/PD
model analysis ability
Rapid response to emergency projects
Xihua Headquarters
Address：
Buildings 6, 7and 8, Lane 118, Furonghua Road, Pudong New Area, Shanghai Municipality
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