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Medicilon's Preclinical Research-Pharmacology, PK, and Safety Evaluation Services

2022-03-24
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Medicilon pre-clinical research services provide clients with the solutions to transform candidate compounds for clinical trial approval.
Our integrated pre-clinical research services include PRE-CLINICAL SAFETY ASSESSMENT GLP & NON-GLP、 pharmacokinetic studies 、 Small Molecule Bioanalysis, and Large Molecule Bioanalysis, etc.

PRE-CLINICAL SAFETY ASSESSMENT GLP & NON-GLP

In Vivo Toxicology

• General toxicology

• Safety pharmacology

• Reproductive toxicology

• Genetic toxicology

• Inhalation toxicology

• Immunotoxicology

• Carcinogenicity study

• Local toxicity study (hemolysis, allergy, and irritation tests)

Histopathology

• H&E staining

• Immunohistochemistry (IHC)

• Tissue cross-reaction (TCR)

Clinical Pathology

• Hematological analysis

• Urinalysis

• Clinical biochemical analysis

• Hemagglutination analysis

• Lymphocyte typing

PHARMACOKINETICS

In Vitro ADME

• Lipophilicity, solubility tests

• Caco-2 permeability

• Transporters: substrate and inhibition studies

• hERG test

In Vivo DMPK

• Pharmacokinetics screening service

• Pharmacokinetics for IND submission

• Toxicokinetic for IND submission

BIOANALYSIS

Small Molecule Bioanalysis

• Early selection of DMPK/ADME in vitro and in vivo

• Preclinical GLP-based pharmacology and toxicology experiment

• Bioequivalence (BE) experiment of generic drugs

• Sample analysis of global clinical trials

• Development of LC-MS/MS method and verification of methodology

• Synthesis of standards and isotope internal standards

Large Molecule Bioanalysis

• Development and methodological verification

• Analysis of proteins, antibodies, polypeptides and drugs

• Biological markers

• Vaccine analysis

• Immunogenicity tests

CERTIFICATES

Medicilon has an AAALAC accredited animal facility supporting a wide variety of rodent and nonrodent animal experiments, and our pre-clinical labs are compliant with FDA、EMA, and TGA and certified by the Chinese NMPA for GLP.

Certificates-&-Compliance.jpg

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