ICH Q14 Guideline: Science-Based Analytical Procedure Development

adicionou um novo artigo Health

2026-11-14 18:07:54

In the highly regulated pharmaceutical and life sciences sector, the quality of a drug substance or drug product is only as reliable as the analytical procedures used to test it. Historically, analytical methods were developed using empirical, trial-and-error "minimal" approaches, often resulting in rigid methods that triggered extensive regulatory hurdles whenever a minor change was required...

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