In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...
Specifications ensure drug substances/products meet acceptance criteria, forming a foundation for robust control strategies. Validated methods must be fit for purpose, with MODRs providing flexibility ...
Learn when static methods can’t be unit tested and how to use wrapper classes and the Moq and xUnit frameworks to unit test them when they can When building or working in .NET applications you might ...
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