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Biological Sample Analysis
Small molecule drug research
Relying on the GLP laboratory animal center certified by AAALAC, IPHASE operates the analysis and testing laboratory in strict accordance with the ISO/IEC 17025 quality management system, and has obtained the CNAS certificate and the CMA certificate from the China National Accreditation Service for Conformity Assessment, which can meet the screening and development of small molecular drugs for customers.
service content
Support IND/NDA declaration
Complete validation of biological sample analysis methods: selectivity/specificity, linearity and sensitivity, precision, accuracy, matrix effect, recovery, stability, dilution linearity, interference test, etc
In vivo and in vitro test design: blood drug concentration-time curve, absorption, distribution, excretion, plasma protein binding, biotransformation, influence on drug metabolism enzyme activity and transporter, material balance, etc
Analysis of pharmacokinetic characteristics and issuance of summary report
Original data saving
Accept on-site verification
Reference standards
The project is carried out in strict accordance with the requirements of the Guidelines for the Administration of Biological Sample Analysis Laboratory in Clinical Drug Trials (Trial). The validation of analytical methods and sample testing are based on the FDA Guidelines for the Validation of Biological Sample Analytical Methods The work was carried out in accordance with the guiding principles of the EMA Guidelines for Bioequivalence Research and Biosample Analysis and the Guidelines for Quantitative Analysis of Biological Samples in the Chinese Pharmacopoeia 2020. Huizhi Taikang Laboratory has also formed a complete quality management system, with hundreds of SOPs covering six major aspects: general management, quality assurance, pre-analysis preparation, laboratory analysis and detection technology, instruments and equipment, computer and software and hardware systems. Before the implementation of methodological verification and sample testing for each project, the Methodological Verification Plan and the Sample Analysis and Research Plan are formed respectively, and the test is carried out after the approval of the entrusting party. The compliance of each work and the traceability of data and records meet the verification requirements