DMPK_Shanghai Xihua Scientific Co.,Ltd.

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DMPK

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

具有相关资质的供应商
检验检疫合格
定期动物体检
实验动物定期第三方质检

人员、物品进出严格管控
日常的清洁、消毒
设施环境符合标准
每批次提供质量检测报告
定期水质检测

· 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