|
gptkbp:instanceOf
|
gptkb: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
|
|
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
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
ICH Guidelines
|