Carcinogenicity assessments of biotechnology-derived pharmaceuticals: a review of approved molecules and best practice recommendations (Q37753534)

22 August 2017

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title

Carcinogenicity assessments of biotechnology-derived pharmaceuticals: a review of approved molecules and best practice recommendations (English)

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22 August 2017

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2

Gregory L Finch

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22 August 2017

John L Vahle

1

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22 August 2017

Shawn M Heidel

3

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22 August 2017

David N Hovland

4

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22 August 2017

Inge Ivens

5

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22 August 2017

Suezanne Parker

6

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22 August 2017

Rafael A Ponce

7

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22 August 2017

Clifford Sachs

8

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22 August 2017

Ronald Steigerwalt

9

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22 August 2017

Brian Short

10

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22 August 2017

Marque D Todd

11

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22 August 2017

language of work or name

English

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publication date

14 May 2010

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22 August 2017

Toxicologic Pathology

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22 August 2017

38

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22 August 2017

522-553

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22 August 2017

4

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Risk of malignancy with long-term immunosuppression in renal transplant recipients.

22 August 2017

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Assessing cellular proliferation: what's worth measuring?

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Neoplastic lesions of questionable significance to humans

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Risk of leukemia in children treated with human growth hormone: review and reanalysis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Rheumatoid arthritis and malignant lymphomas

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Coordinate expression and trans presentation of interleukin (IL)-15Ralpha and IL-15 supports natural killer cell and memory CD8+ T cell homeostasis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Alternative strategies for toxicity testing of species-specific biopharmaceuticals

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Complications and adverse reactions in the use of newer biologic agents

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Predictive value of proliferation, differentiation and apoptosis as intermediate markers for colon tumorigenesis.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate?

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Human carcinogenic risk evaluation: an alternative approach to the two-year rodent bioassay

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Systemic complications of acromegaly: epidemiology, pathogenesis, and management

21 January 2018

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https://api.crossref.org/works/10.1177%2F0192623310368984

Interleukin-21 signaling: functions in cancer and autoimmunity

21 January 2018

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https://api.crossref.org/works/10.1177%2F0192623310368984

The immunobiology of cancer immunosurveillance and immunoediting

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Recombinant rat and mouse growth hormones: risk assessment of carcinogenic potential in 2-year bioassays in rats and mice

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Keratinocyte growth factor expression and activity in cancer: implications for use in patients with solid tumors

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Human KGF is FGF-related with properties of a paracrine effector of epithelial cell growth

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Ultrasound detection of non-Hodgkin's lymphoma in three cynomolgus monkeys after renal transplantation and cyclosporine immunosuppression

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Nonhuman primate infections after organ transplantation.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Parathyroid hormone and teriparatide for the treatment of osteoporosis: a review of the evidence and suggested guidelines for its use.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Carcinogenesis studies: results of 398 experiments on 104 chemicals from the U.S. National Toxicology Program

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Human carcinogenic risk evaluation, Part III: Assessing cancer hazard and risk in human drug development

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Use of transgenic mice in carcinogenicity hazard assessment

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Defining a noncarcinogenic dose of recombinant human parathyroid hormone 1-84 in a 2-year study in Fischer 344 rats.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Incidence of lymphoma in patients with rheumatoid arthritis: a systematic review of the literature

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Protein therapeutics: a summary and pharmacological classification

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

A review of malignancies observed during efalizumab (Raptiva) clinical trials for plaque psoriasis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Simian retrovirus infections: potential confounding variables in primate toxicology studies

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Interrelationships among angiogenesis, proliferation, and apoptosis in the tumor microenvironment during N-methyl-N-nitrosourea androgen-induced prostate carcinogenesis in rats

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Simian varicella virus reactivation in cynomolgus monkeys

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Influence of immunosuppression on the prevalence of cancer after kidney transplantation

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Long-term mortality in the United States cohort of pituitary-derived growth hormone recipients.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Recombinant full-length parathyroid hormone (1-84): profile report

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

IL-21 enhances and sustains CD8+ T cell responses to achieve durable tumor immunity: comparative evaluation of IL-2, IL-15, and IL-21

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

The Tg rasH2 mouse in cancer hazard identification

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

TNF-alpha inhibitor etanercept and hematologic malignancies: report of a case and review of the literature

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Effects of keratinocyte growth factor on the proliferation and radiation survival of human squamous cell carcinoma cell lines in vitro and in vivo

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Preclinical studies of erythropoietin receptor expression in tumour cells: impact on clinical use of erythropoietic proteins to correct cancer-related anaemia

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Malignant melanoma in organ allograft recipients.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Solid tumors after heart transplantation: lethality of lung cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Progress in human tumour immunology and immunotherapy

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Carcinogenicity testing of IL-10: principles and practicalities

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Keratinocyte growth factor.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Purification and characterization of a newly identified growth factor specific for epithelial cells

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Impact of infections and normal flora in nonhuman primates on drug development

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Cancer after transplantation

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Nonclinical safety of ziconotide: an intrathecal analgesic of a new pharmaceutical class

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Application of a statistical dynamic model investigating the short-term cellular kinetics induced by riddelliine, a hepatic endothelial carcinogen

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

The rasH2 transgenic mouse: nature of the model and mechanistic studies on tumorigenesis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Teriparatide [human PTH(1-34)]: 2.5 years of experience on the use and safety of the drug for the treatment of osteoporosis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

CB6F1-rasH2 mouse: overview of available data

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Bone neoplasms in F344 rats given teriparatide [rhPTH(1-34)] are dependent on duration of treatment and dose.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Lack of bone neoplasms and persistence of bone efficacy in cynomolgus macaques after long-term treatment with teriparatide [rhPTH(1-34)].

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Second malignancies after treatment for Hodgkin's disease

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Biopharmaceutical benchmarks 2006.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Immune suppression in cancer: effects on immune cells, mechanisms and future therapeutic intervention

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

Validation of transgenic mice harboring the human prototype c-Ha-ras gene as a bioassay model for rapid carcinogenicity testing

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

The risk of lymphoma development in autoimmune diseases: a meta-analysis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623310368984

21 January 2018

Identifiers

DOI

10.1177/0192623310368984

1 reference

22 August 2017

1 reference