Analytical Method Validation

Analytical Method Validation

QbD

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This book contains essays on data integrity. Data integrity is the most basic element of work in any scientific discipline. Nothing of lasting value in the hard sciences (physics, chemistry, biology, astronomy, et al.) lacks integrity in the data used to support the premises, the logical arguments proposed, and the conclusions drawn. The point of validation is, after all, to ensure that all results obtained and reported are true. The original premise of our book was to merge the global standard for pharmaceutical analytical methods for regulatory applications [ICH Q2(R1)] with contemporary thi...