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[...] Sandoz submitted that the skilled team would know that, in the course of submitting an application for regulatory approval for a calcipotriol aqueous suspension cream, it could expect to be required by the regulatory authority to check whether the Active Pharmaceutical Ingredient (API) formed...

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Bibliographic Details
Published inJournal of generic medicines Vol. 7; no. 2; pp. 195 - 203
Main Authors Burdon, Michael, Kusumakar, Siddharth, Katzka, Catherine
Format Journal Article
LanguageEnglish
Published London, England SAGE Publications 01.04.2010
Sage Publications Ltd
Subjects
Crystal lattices
Law firms
Regulation
Regulatory approval
Seeds
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Summary:[...] Sandoz submitted that the skilled team would know that, in the course of submitting an application for regulatory approval for a calcipotriol aqueous suspension cream, it could expect to be required by the regulatory authority to check whether the Active Pharmaceutical Ingredient (API) formed a hydrate. [...] the skilled team would be bound to check for the presence of hydrates in any event, in the course of routine stability studies.
ISSN:1741-1343
1741-7090
DOI:10.1057/jgm.2010.9