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Handbook Of Stability Testing In Pharmaceutical Development

Обложка книги Handbook Of Stability Testing In Pharmaceutical Development

Handbook Of Stability Testing In Pharmaceutical Development

Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.
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