Vimta Labs Ltd. The A8 Global Harmonization Team focused on the documentation needed to support both small and large molecule bioanalysis. Current regulatory requirements were compiled and compared. A common high-level table of contents for method validation and sample analysis reports is proposed. Suggestions have been made as to how the CTD can be standardized to improve usability and review.
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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. We have a foundation for regulated bioanalysis in BMV Guidance but new and rapidly evolving challenges await us.
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The instrumentation at our facilities is state-of-the-art, and we constantly upgrade equipment to remain at the forefront of the industry. Our lab equipment can be used for small molecule bioanalysis, large molecule bioanalysis, and DMPK. A mass spectrometer that collects both quantitative and qualitative information from the same run. A mass spectrometer that excels at multi-component quantitation , required by environmental, targeted quantitative proteomics, clinical research, and food and beverage applications. A mass spectrometer that can obtain sensitive results for drug development and provides high throughput efficiency, with low detection limits for trace analysis.
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.