Statements (31)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:adoptedBy |
1993
|
| gptkbp:appliesTo |
new drug products
new drug substances |
| gptkbp:defines |
storage conditions
stability testing protocols testing conditions testing duration testing frequency |
| gptkbp:documentType |
regulatory guideline
|
| gptkbp:focusesOn |
stability testing
|
| gptkbp:fullName |
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH Q1A (Stability Testing)
|
| gptkbp:issuedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:language |
English
|
| gptkbp:latestReleaseVersion |
2003
|
| gptkbp:purpose |
to determine shelf life
to determine storage conditions to ensure drug quality over time |
| gptkbp:region |
gptkb:Europe
gptkb:Japan gptkb:United_States |
| gptkbp:relatedTo |
ICH Q1B (Photostability Testing)
ICH Q1C (Stability Testing for New Dosage Forms) ICH Q1E (Evaluation of Stability Data) ICH Q1D (Bracketing and Matrixing Designs for Stability Testing) |
| gptkbp:usedBy |
pharmaceutical industry
regulatory authorities |
| gptkbp:website |
https://www.ich.org
|
| gptkbp:bfsParent |
gptkb:ICH_Guidelines
|
| gptkbp:bfsLayer |
7
|