The research and development of innovative drugs is a long-term process with high investment, high risk and high return. It takes more than ten years on average from early discovery to successful listing, and the cost is as high as more than 1 billion US dollars. Pharmacokinetics (DMPK) research runs through all stages of lead compound discovery, lead compound optimization, preclinical candidate compound (PCC) selection, preclinical development, clinical trials, etc., helping to improve the efficiency of new drug development and reduce the risk of failure in the later stages of development Plays an important role. Medicilon is your ideal partner to carry out all kinds of DMPK research.
Advanced Biological Analysis platform
Medicilon is one of the first new drug R&D CROs in China to introduce tandem mass spectrometers and carry out biological analysis services. In recent years, it has continued to invest heavily in introducing high-end equipment, and has now built 16 sets of Sciex/Waters/Shimadzu ultra-high performance liquid- Tandem mass spectrometry system (UHPLC-MS/MS), inductively coupled plasma mass spectrometer (ICP-MS) as the representative instrument of small molecule biological analysis platform and MSD high-throughput multi-protein detector, Luminex liquid chip protein analysis system, Gyrolab nano-upgraded microfluidic immunoassay workstation and Applied Biosystems real-time fluorescent quantitative PCR system are representative instruments of macromolecular bioanalysis platform, for early in vitro ADME, screening PK, preclinical declaration DMPK/TK, and clinical trials and bioequivalence of generic drugs Sex (BE) testing provides strong support.
Medicilon’s experienced and comprehensive pre-clinical in vivo and in vitro DMPK research team provides diversified services from early screening to IND application research for customer groups ranging from local startups to Top10 global manufacturers. The research fields cover metabolic stability, P450 enzyme inhibition, P450 enzyme induction, enzyme phenotype analysis, protein binding, red blood cell/plasma partition ratio, Caco-2 permeability, transporter research, metabolite identification, multi-path administration PK, tissue distribution and blood brain Barrier permeability, excretion studies, in vivo drug interactions, multi-period crossover BE/prescription screening, etc. Medicilon’s comprehensive training mechanism, comprehensive quality control (QC) system and scientific and efficient project management system provide a strong guarantee for the efficient and high-quality completion of various DMPK projects.
Test Quality and Animal Welfare
Medicilon has a high-standard animal room certified by the International Association for Laboratory Animal Management Evaluation and Certification (AAALAC) and an animal use management system centered on IACUC supervision. By implementing the 3R (reduction, substitution, optimization) principle by improving animal experiment technology and perfecting the in vitro experiment platform, the quality of experiment and animal welfare promote each other and complement each other in Medicilon. For example, compared with the traditional single-point or cross-sampling method, the mouse continuous micro blood sampling technology significantly reduces the amount of animals in the mouse PK experiment and the consumption of the customer’s test product. A complete blood concentration curve can be obtained from a single mouse. Compared with the traditional method in which blood concentrations of up to 8 mice are combined into a curve at different time points, the error introduced by individual differences is significantly reduced.