Service Introduction
InnoStar's small molecule bioanalytical platform provides a full-flow solution for innovative drug discovery and development in compliance with global regulatory standards. Strictly complying with international regulatory requirements such as NMPA/FDA/EMA/OECD/ICH, the platform is equipped with ultra-sensitive liquid-mass spectrometry systems (AB Sciex 7500/6500+/6500/5500/4000, etc.) and Watson LIMS systems complying with 21 CFR Part 11 to guarantee the ALCOA+ principle.
The core team members are all scientists with 7+ years of bioanalytical experience, which enables us to rapidly advance method development, validation and clinical sample testing of innovative small molecule drugs, peptides, small nucleic acids, ADC drugs, etc., while ensuring data integrity, authenticity and accuracy.
Services
- PK analysis
-Bioequivalence studies (BE)
-Metabolite identification
-Material balance
-Biomarkers
Drug Types
-Chemicals and metabolites
-Principal Components of Traditional Chinese Medicines
-Protac/molecular gel
-Peptides
-Insulin
-PDC
-ADC
-Small nucleic acid drugs
Detectable Substrates
-Plasma
-Serum
-Urine
-Tissue
-Feces
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