ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

E555163

ICH guideline nonclinical safety guideline regulatory guideline

ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals is an international guideline that outlines the nonclinical safety testing requirements for biotechnological products such as therapeutic proteins and monoclonal antibodies to support their clinical development and marketing authorization.

Try in SPARQL Jump to: Statements Referenced by

Statements (49)

Predicate	Object
instanceOf	ICH guideline ⓘ nonclinical safety guideline ⓘ regulatory guideline ⓘ
addresses	biological activity and potency testing in nonclinical programs ⓘ carcinogenicity testing considerations for biotechnology-derived products ⓘ dose selection for nonclinical studies ⓘ duration of nonclinical studies ⓘ genotoxicity testing considerations for biotechnology-derived products ⓘ immunogenicity assessment in nonclinical studies ⓘ local tolerance testing for biotechnology-derived products ⓘ reproductive toxicity testing considerations for biotechnology-derived products ⓘ safety assessment of impurities in biotechnology-derived products ⓘ safety evaluation of cytokines and growth factors ⓘ safety evaluation of monoclonal antibodies ⓘ safety evaluation of recombinant proteins ⓘ safety pharmacology considerations for biotechnology-derived products ⓘ selection of relevant animal species ⓘ species specificity of biotechnology-derived products ⓘ toxicology study design for biotechnology-derived pharmaceuticals ⓘ use of pharmacologically relevant animal models ⓘ
aimsTo	harmonize international requirements for nonclinical safety testing of biotechnology-derived pharmaceuticals ⓘ reduce duplication of nonclinical studies across regions ⓘ
appliesTo	biotechnology-derived pharmaceuticals ⓘ monoclonal antibodies ⓘ therapeutic proteins ⓘ
covers	biomarker use in nonclinical safety studies ⓘ first-in-human dose selection considerations for biotechnology-derived products ⓘ study endpoints relevant to biotechnology-derived products ⓘ translation of nonclinical findings to clinical risk assessment ⓘ
documentType	scientific guideline ⓘ
focusesOn	nonclinical safety testing requirements ⓘ preclinical safety evaluation ⓘ
hasAbbreviation	ICH S6 NERFINISHED ⓘ
hasVersion	ICH S6(R1) NERFINISHED ⓘ
issuedBy	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ
language	English ⓘ
region	European Union NERFINISHED ⓘ Japan NERFINISHED ⓘ United States of America ⓘ surface form: United States
relatedTo	ICH M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization NERFINISHED ⓘ ICH Q5 series guidelines on quality of biotechnological products NERFINISHED ⓘ
supports	clinical development of biotechnology-derived pharmaceuticals ⓘ marketing authorization of biotechnology-derived pharmaceuticals ⓘ
targetAudience	nonclinical safety scientists ⓘ regulatory affairs professionals ⓘ
updateOf	original ICH S6 guideline ⓘ
usedBy	biotechnology companies ⓘ pharmaceutical companies ⓘ regulatory authorities ⓘ

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.

ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals → relatedTo → ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals ⓘ