Stability Testing :

• A

  • Available Date : The target date minus the time point window interval.
  
  

• B

  • Base Date : This date corresponds to the date the formulation was put on stability testing. The available, required and target dates are calculated from the base date.
  
  
  • Batch : Usually this refers to a production batch, also referred to as formulation or test article in this manual
  
  

• C

  • Condition : The temperature and humidity condition that the sample will be stored in are specified in the condition
  
  

• F

  • Formulation : See definition of Test Article
  
  
  • Formulation template : A template that is used to define the fields that appear in the Add Formulation and Modify Formulation dialogs.
  
  

• L

  • Level : This is typically used for packaging variation (for example upside or downside) but may be used for any additional study variable
  
  

• P

  • Protocol : A test plan consisting of levels, time points, conditions and formulations. Must be approved before a study can be created
  
  
  • Protocol Template : See definition of Stability Protocol Template
  
  

• R

  • Required Date : The target date plus the time point window interval.
  
  

• S

  • Scheduled Login : Sample that are scheduled to be logged in just after midnight on the Available Date.
  
  
  • Stability Level : See definition of Level
  
  
  • Stability Protocol : See definition of Protocol
  
  
  • Stability Protocol template : A matrix of levels, time points, and conditions that is used to create a protocol.
  
  
  • Storage Condition : See definition of Condition
  
  
  • Storage Location : Location of sample, as defined in the Locations table
  
  
  • Study : A collection of samples
  
  

• T

  • Target Date : The base date plus the time point interval.
  
  
  • Test Article : This is the formulation of the material being tested. It is also known as a batch.
  
  
  • Timepoint : This is the point in time when the sample will be tested (taken relative to the base date).