Statements (27)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
pharmaceutical guideline
|
| gptkbp:appliesTo |
pharmaceutical industry
regulatory authorities |
| gptkbp:covers |
safety
quality efficacy multidisciplinary topics |
| gptkbp:developedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:firstIssueDate |
1990
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH Guidelines
|
| gptkbp:language |
English
|
| gptkbp:notableGuideline |
gptkb:ICH_E6_(Good_Clinical_Practice)
gptkb:ICH_M4_(Common_Technical_Document) gptkb:ICH_Q1A_(Stability_Testing) gptkb:ICH_Q2_(Analytical_Validation) gptkb:ICH_Q3A_(Impurities_in_New_Drug_Substances) gptkb:ICH_Q7_(GMP_for_APIs) |
| gptkbp:purpose |
harmonize technical requirements for pharmaceuticals
|
| gptkbp:region |
gptkb:Europe
gptkb:Japan gptkb:United_States |
| gptkbp:updated |
gptkb:ICH_Steering_Committee
|
| gptkbp:usedBy |
regulatory agencies
pharmaceutical companies |
| gptkbp:website |
https://www.ich.org
|
| gptkbp:bfsParent |
gptkb:EMA_Guidelines
|
| gptkbp:bfsLayer |
6
|