The application of ICH S6 to the preclinical safety evaluation of plasma derivative therapeutic products

Biologicals

Volumn 38, Issue 4, 2010, Pages 494-500

  Lewis, Richard M ^a   Cavagnaro, Joy ^a  

^a Access BIO   (United States)

Author keywords

ICH S6; Plasma derivative; Preclinical; Safety Evaluation; Toxicology

Indexed keywords

ALPHA 1 ANTITRYPSIN; BLOOD CLOTTING FACTOR; BLOOD CLOTTING FACTOR 9 CONCENTRATE; COMPLEMENT COMPONENT C1S INHIBITOR; EXCIPIENT; FIBRIN; FIBRINOGEN; HEPATITIS B ANTIBODY; IMMUNOGLOBULIN; IMMUNOGLOBULIN G; PLASMA PROTEIN; PROTEIN C; PROTEIN DERIVATIVE; THROMBIN; VON WILLEBRAND FACTOR;

ANTIGEN ANTIBODY REACTION; ANTIGENICITY; AREA UNDER THE CURVE; BIOTECHNOLOGY; CARCINOGENICITY; CHRONIC TOXICITY; CLINICAL TRIAL; DEVELOPMENTAL DISORDER; DRUG DETERMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; EYE TOXICITY; GENOTOXICITY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IMMUNOTOXICITY; NONHUMAN; NOTE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REPEATED DRUG DOSE; REPRODUCTIVE TOXICITY; SINGLE DRUG DOSE; SKIN IRRITATION; SKIN TOXICITY; THROMBOGENICITY; TOXICITY TESTING;

ANIMALS; BIOLOGICAL PRODUCTS; BLOOD PROTEINS; CLINICAL TRIALS AS TOPIC; CONGRESSES AS TOPIC; DRUG EVALUATION, PRECLINICAL; DRUG TOXICITY; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL AGENCIES; INTERNATIONAL COOPERATION; PHARMACOPOEIAS AS TOPIC; REPRODUCIBILITY OF RESULTS; TECHNOLOGY, PHARMACEUTICAL;

ANIMALIA;

EID: 77955305691     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.03.001     Document Type: Note

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