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Analytical R&D

Home > Solutions > Analytical R&D
A Consistent and Reliable Approach to Analytical R&D

Methods for characterizing new drug substances and intermediates, as well as methods for monitoring chemical processes used to make new drug substances, are identified and developed in Analytical R&D.  Such analytical methods ensure that samples of new drug substances used for preclinical and clinical evaluation meet requisite quality benchmarks. 
 
Inference for QbD provides Analytical R&D teams with the following benefits (categorized by team member role):
 
Analytical Scientists
  • enjoy a consistent approach to identification of analytical parameters critical to analytical method performance in analytical methods using the standardized and validated Inference for QbD function library
  • employ a reliable approach to identifications, visualization, documentation and verification of analytical method design space using the Inference for QbD template library
  • gain valuable analytical method understanding from low-value analytical data using machine learning methods
  • save time by automating repetitive QbD tasks, e.g. creating standard analyses reports and capturing them in an electronic lab notebook
  • save time by rapidly prototyping, testing and deploying new data-analysis methods for QbD applications
  • shorten turn-around time for delivery of custom analytical reports by enabling the scientists to perform data pipelining and documentation directly in Inference Word
  • easily find and reuse prior QbD information from a global searchable database of QbD data-analysis methods for assembly into SOPs

Analytical Managers

  • deploy a consistent approach to implementing QbD goals across Analytical R&D
  • ensure consistent, accurate and traceable Analytical QbD records and reports
  • shorten time-to-decision and improve efficiency by providing streamlined, regulatory compliant Analytical workflows
  • improve Analytical R&D’s capability to share and collaborate on QbD projects
  • leverage and exploit an underutilized asset: QbD information from prior Analytical projects 
  • collect a broadly accessible, enterprise wide analytical R&D knowledge base for training new employees and initiating future QbD projects
  • improve decision quality and reduce time-to-decision by supplying facts-based predictive modeling of analytical methods to entire R&D team
  • shorten QbD training by using templates and leveraging familiarity with Microsoft Office

Adjoining Development Functions

  • clearly communicate QbD project status, uncertainties and development strategy to senior stakeholders and the entire development team
  • enable adjoining development functions involved in QbD project to have real-time access to relevant analytical R&D information
  • support regulatory by maintaining QbD study data in a searchable 21 CFR Part 11 compliant centralized repository with full audit trails
  • enable regulatory and CMC project teams to easily assemble standardized QbD results for CMC filing
  • support process engineering during scale-up and validation by enabling direct access to analytical QbD information
  • support IT by providing: a single platform that spans the full development organization; a standards-based architecture that is scalable to thousands of users; and a set of core applications that requires minimal training and support built on familiar Microsoft Office
 
 
Learn More
Documents
Results Document R CPP of SDA assay.pdfResults Document R CPP of SDA assay
INF03+ R CPP of SDA assay.pdfINF03+ R CPP of SDA assay
Screencasts
  Overview of Inference for Office
  Perform Data Analysis Using an Inference Template
  Build and Deploy an Inference Template
  Test-Driven Data-Analysis Method Development
  Verify New Data Analysis Method using Inference
Screenshots
Distribution in wtpercent active and unsupervised classication by spectra
Comparison of actual vs. predicted wtpercent and partial dependance of wtpercent active prediction on tablet attributes
 
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