Page History
- 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.
- STOCONID is applicant-defined, but it must be unique with regard to the specific set of storage conditions contained in the ES dataset.
- STOCONID can also be used in the PT domain where the storage conditions it identifies are applicable to observations contained in that domain
(e.g, when representing the results of stability studies in the PT domain that were conducted under a set of storage conditions represented in ES).Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-125
- ESPARMCD/ESPARM are the parameters of the storage conditions. Examples of storage condition parameters include temperature, humidity, percent oxygen, climate zone, etc.
Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-180 - Timing and duration of storage
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).Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-225
Overview
Content Tools