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Micromolecular Drugs Bioanalysis

Micromolecular Drugs Bioanalysis

Our Bioanalysis Department can provide bioanalysis of micromolecular drugs in accordance with standards of FDA/NMPA GLP to support the selection and development, preclinical and clinical research of micromolecular drugs.
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Medicilon diamond icon.pngHighlights
  • Service team for bioanalysis of micromolecular drugs composed of experienced employeesEmployment of verified laboratory information management system (Watson LIMS 7.2) to manage samples and experiment dataReview by US FDA and GLP certificate by NMPA Bioanalysis of micromolecular drugs for global clients
Medicilon diamond icon.pngService
  • Early use of DMPK/ADME in vitro and in vivoPreclinical GLP-based pharmacology and toxicology experimentBioequivalence (BE) exaluation of drugsSample analysis of global clinical trialsDevelopment of LC-MS/MS method and verification of methodologyDevelopment, transfer and optimization of LC-MS/MS method for determination of drug concentration in biological matrixRapid verification of methodology to support needs of potential projects including development, transfer and verification of methodology  Development, transfer and verification of methodology          Synthesis of standards and isotope internal standardsShort-term and fast synthesis of standards and isotope internal standards in Chemical Synthesis and Radiosynthesis Laboratory
Medicilon diamond icon.pngInstruments
  • Sciex Triple Quad 7500:1Waters Acquity UHPLC:  20Sciex Triple Quad 6500+:  18Shimadzu UHPLC:  12Sciex Triple Quad 5500:  10Thermo Vanquish UHPLC:1Sciex Triple Quad 4000:1Thermo Orbitrap Exploris 240 : 1Shimadzu MS 8050:  1Waters Acquity UPLC Xevo TQ-XS:2Thermo Orbitrap Exploris 240:1Thermo Q Exactive HF-X:1Sciex API 4000:1
Medicilon diamond icon.pngSample Pre-treatment & Storage
  • Biotage Lycera Bead Mill HomogenizerAgela SPE-M96 Positive Pressure DeviceMP Bio Fastprep-24 Bead Mill HomogenizerBiotage SPE Dry 96 Sample ConcentratorIKA ULTRA-TURRAX T25 Digital DisperserEppendorf Refrigerated CentrifugesMilli-Q Integral 10
Service Cases

Medicilon Assists CGeneTech's Oral Hypoglycemic DPP-4 Inhibitor, New Drug Application (NDA) Accepted.webp

Medicilon Assists CGeneTech's Oral Hypoglycemic DPP-4 Inhibitor, New Drug Application (NDA) Accepted

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Relevant laboratories
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