Analytical Method Development and Validation

Analytical method development is the process of choosing an accurate assay procedure to determine the composition of a formulation. It is the process of proving that an analytical method is acceptable for use in laboratory to measure the concentration of subsequent samples Analytical methods should be recycled within GMP and GLP environments and must be developed using the protocols and acceptance conditions set out in the ICH guidelines. Analytical method development and validation stand the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It supports in formation of product-specific acceptance criteria and stability of results. Validation should establish that the analytical procedure is suitable for its intended purpose. Design of experiment is a powerful tool for the method characterization and validation. 

 

  • Electroanalytical methods
  • Fluorescence techniques
  • Nanotechnology applications in analytical methods
  • Forensic analytical techniques
  • Drug screening: Strategy and methods
  • HPLC analytical method development and validation
  • Analytical methods and biomarker validation
  • analytical research methodology
  • chemical analytical methods
  • analytical marketing

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