Whitepapers on ACD/Labs Software and Solutions

Read a new whitepaper that describes the significant advances in pharmaceutical stress testing over the past 20 years, largely through the development of several novel analytical and automation tools, like ACD/Labs Luminata.

In this white paper we provide commentary on factors that impact analytical data standardization and a vision of the considerations and requirements that such an undertaking should include.

This white paper discusses how a new technological approach can help effectively capture, retrieve, and re-analyze knowledge gained from analytical data generation in formulated products R&D.

Read how to:

• Capture knowledge associated with data analysis and problem-solving for future through an effective informatics framework
• Reduce duplication of effort where the same problems are solved over and over again
• Retain valuable intellectual property
• Deliver better ROI on investments in analytical instrumentation and analytical data generation

Unified Laboratory Intelligence (ULI) is an R&D informatics category focused on the collection, unification, and enrichment of 'live' analytical data content with chemical and reaction-based context. Impurity Resolution Management (IRM) is a specific application of ULI to identify and characterize impurities for control, resolution, and reporting during the development and acceptance of a new drug substance. IRM enables cross-functional scientific collaboration among the process chemistry, analytical chemistry, and structure characterization, identification, and elucidation groups through comprehensive and dynamic visualization, optimal method development, and quick and easy reporting. With a fully searchable electronic repository or process knowledge, IRM can capture legacy knowledge to solve future problems and provide quick and easy access to knowledge for prompt responses to regulatory filing agencies.

Quality by Design (QbD) has become popular within the pharmaceutical industry and the FDA has cited a riskbased approach to drug development as desirable for the near future. More complete information and transparency relating to risk assessment will be made available for new drug applications, speeding the approval process and preventing late‐stage failures.