ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
GPTKB entity
Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:appliesTo |
biotechnology-derived pharmaceuticals
|
| gptkbp:covers |
cytokines
growth factors monoclonal antibodies recombinant proteins immunomodulators gene therapy products |
| gptkbp:firstPublished |
1997
|
| gptkbp:focusesOn |
preclinical safety evaluation
|
| gptkbp:guidanceSystem |
nonclinical safety studies
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
|
| gptkbp:issuedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:language |
English
|
| gptkbp:relatedTo |
ICH guidelines
|
| gptkbp:updated |
2011
ICH S6(R1) |
| gptkbp:usedBy |
pharmaceutical industry
regulatory authorities |
| gptkbp:website |
https://www.ich.org/page/safety-guidelines
|
| gptkbp:bfsParent |
gptkb:ICH
|
| gptkbp:bfsLayer |
6
|