Bioanalysis is vital throughout every stage of drug discovery and development, CMIC provides cutting-edge capabilities and sophisticated expertise to enable sponsors to overcome their research challenges. We provide bioanalysis services for all development stages, both GLP and non-GLP, within a state-of-the-art facility that has the capacity to accommodate quick turnaround for high-volume projects from around the globe. As your strategic partner, we help streamline your drug development efforts to maximize the probability of success and minimize drug development time and costs. Our laboratories perform bioanalysis and various biomarker measurements utilizing advanced instrumentation.
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Stephen Lowes, Ph. January 17, Introduction Here at the beginning of it seems fitting to update my personal thoughts on the status of regulated bioanalysis including how we are adapting to the finalized FDA BMV Guidance and anticipate what may lie ahead. As expected the FDA Guidance has generated healthy debate on the practices of bioanalytical method validation BMV , primarily around compliance with guidance language. We are now experiencing the introduction of techniques that supplement the traditional chromatographic or ligand binding technologies in the bioanalytical laboratory. These can present formidable challenges when correlating again BMV Guidance language.
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Whether you are developing a small or large molecule drug, our dedicated bioanalytical team provides a wide range of services including method development, method qualification and sample collection protocol design. Work is conducted to appropriate standards ranging from high throughput research quality, to Good Laboratory Practice GLP assays, suitable for discovery and preclinical development. The bioanalytical team offers optimized project workflows, an exceptional staff training program and robust state-of-the-art technology platforms. These high-quality platforms provide a strong bioanalytical capability to support both small and large molecule development. This includes biomarkers, immunogenicity and pharmacokinetic PK studies.
October Historically, mass spectrometers have been used largely in drug discovery owing to their qualitative capabilities and have escaped rigorous regulation. This is clearly no longer the case.