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changes.mady.by.user Christine Connolly

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  1. ES is a study reference dataset that provides a consistent identifier–the Applicant-defined Storage Conditions ID (STOCONID)–for a set of conditions under which a product was stored during testing. The dataset contains these storage condition parameters (temperature, humidity, etc) and merges those characteristics on this single identifier.
    1. STOCONID is applicant-defined, but it must be unique with regard to the specific set of storage conditions contained in the ES dataset.
    2. STOCONID can also be used in any the PT domain where the storage conditions it identifies are applicable to observations contained in that domain
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      (e.g, it can be used in the PT domain   when representing the results of stability studies).
  2. ESPARMCD/ESPARM are the parameters of the storage conditions. Examples of storage condition parameters include temperature, humidity, percent oxygen, climate zone, etc.
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  3. Timing and duration of storage
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    would be determined in the context of the testing of stored samples from the timing variables used in the domain where the testing results are represented (i.e., the PT domain).