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Pharmaceutical Stability Testing to Support Global Markets

By Kim Huynh-Ba (Editor)
eBook
$159.00
By Kim Huynh-Ba (Editor)
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The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requir...