Invited review: Carcinogenicity assessments of biotechnology-derived pharmaceuticals: A review of approved molecules and best practice recommendations

Toxicologic Pathology

Volumn 38, Issue 4, 2010, Pages 522-553

  Vahle, John L ^a   Finch, Gregory L ^b   Heidel, Shawn M ^a   Hovland Jr , David N ^c   Ivens, Inge ^d   Parker, Suezanne ^e   Ponce, Rafael A ^f   Sachs, Clifford ^g   Steigerwalt, Ronald ^h   Short, Brian ⁱ   Todd, Marque D ^b  

^a ELI LILLY AND COMPANY   (United States)

^b PFIZER INC   (United States)

^c AMGEN INC   (United States)

^d BAYER CORPORATION   (United States)

^e BIOGEN   (United States)

^f AMGEN INC   (United States)

^g CENTOCOR INC   (United States)

^h Takeda San Diego Inc   (United States)

ⁱ ALLERGAN INC   (United States)

Author keywords

Biotherapeutics; Carcinogenicity; Regulatory toxicology; Safety assessment

Indexed keywords

ABATACEPT; ABCIXIMAB; ADALIMUMAB; ALEFACEPT; ALEMTUZUMAB; ALPHAN3 INTERFERON; ALTEPLASE; BASILIXIMAB; BECAPLERMIN; BETA1A INTERFERON; BETRON; BEVACIZUMAB; CAPROMAB PENDETIDE IN 111; CETUXIMAB; CONSENSUS INTERFERON; CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; DACLIZUMAB; DENILEUKIN DIFTITOX; DROTRECOGIN; EFALIZUMAB; ETANERCEPT; EXENDIN 4; FORCALCITONIN; GAMMA1B INTERFERON; GEMTUZUMAB OZOGAMICIN; HUMAN GROWTH HORMONE; HUMAN INSULIN; IBRITUMOMAB TIUXETAN; INFLIXIMAB; INSULIN; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; INTERFERON BETA SERINE; IPRIVASK; ISOPHANE INSULIN; LEPIRUDIN; MECASERMIN RINFABATE; NATALIZUMAB; NEORECORMNON; NESIRITIDE; NEUTRAL INSULIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; NOVOSTASE; OCTREOTIDE; OCTREOTIDE HOSPIRA; OKT 3; OMALIZUMAB; OMNITROP; OPTINSULIN; PALIFERMIN; PALIVIZUMAB; PANITUMUMAB; PARATHYROID HORMONE[1-34]; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; PEGVISOMANT; PRAMLINTIDE; RANIBIZUMAB; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT ANTITHROMBIN III; RECOMBINANT BLOOD CLOTTING FACTOR 7A; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9; RECOMBINANT CHORIONIC GONADOTROPIN; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT FOLLITROPIN; RECOMBINANT GLUCAGON; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; RECOMBINANT HUMAN INSULIN; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RECOMBINANT INTERLEUKIN 11; RECOMBINANT INTERLEUKIN 2; RECOMBINANT LUTEINIZING HORMONE; RECOMBINANT PARATHYROID HORMONE; RECOMBINANT SOMATOMEDIN C; RECOMBINANT THYROTROPIN; RITUXIMAB; SALCATONIN; TASONERMIN; TOSITUMOMAB I 131; TRASTUZUMAB; UNCLASSIFIED DRUG; UNINDEXED DRUG; VIRAFERIN;

BIOASSAY; BIOTECHNOLOGY; CANCER RISK; CARCINOGENICITY; FEASIBILITY STUDY; NONHUMAN; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; TUMOR GROWTH; ANIMAL; CARCINOGEN TESTING; DRUG APPROVAL; DRUG TOXICITY; HUMAN; METHODOLOGY; PHARMACEUTICS;

RODENTIA;

ANIMALS; BIOPHARMACEUTICS; BIOTECHNOLOGY; CARCINOGENICITY TESTS; DRUG APPROVAL; DRUG TOXICITY; HUMANS;

EID: 77953671996     PISSN: 01926233     EISSN: 15331601     Source Type: Journal    
DOI: 10.1177/0192623310368984     Document Type: Review

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