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Service
Biological Sample Analysis Service
We can provide comprehensive quantitative analytical services for a wide range of in vivo biological samples of small and large molecule drugs and metabolites from preclinical stage to clinical studies in. The service platform is equipped with systematically validated instrumentation and electronic system, including multiple triple quadrupole liquid chromatograph-mass spectrometers. We have completed the analysis of pre-BE samples dozens of projects for various dosage forms, and have established a complete library of validated analytical methods.
The R&D team attended the proficiency testing program held by National Institutes for Food and Drug Control in 2019: Proficiency Testing Program for Determination of Ibuprofen in Rat Plasma Ibuprofen by High Performance Liquid Phase Mass Spectrometry, and in 2020, participated in the External Quality Assessment - Pharmacokinetic Laboratory Biological Sample Detection - Concentration of Carbamazepine in Human Plasma program held by the National Health Commission, receiving satisfactory evaluations.
Service Capability:
◆Small molecule in vivo drug analysis: including the development and validation of biological sample analytical methods, biological sample analysis, methods that meet the requirements for preparing dossier, validation protocols, analysis plans, validation reports and sample analysis reports, PK parameter statistics, and stable storage of biological samples. |
◆Large molecule in vivo drug analysis: including the development and validation of analytical methods for animal and clinical PK study samples of peptides and protein drugs. |
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