Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate? (Q36999193)

17 August 2017

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title

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

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17 August 2017

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Janet Clarke

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17 August 2017

Christopher Hurst

2

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Pauline Martin

3

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John Vahle

4

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Rafael Ponce

5

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Barbara Mounho

6

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Shawn Heidel

7

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Laura Andrews

8

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17 August 2017

Theresa Reynolds

9

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17 August 2017

Joy Cavagnaro

10

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language of work or name

English

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publication date

24 August 2007

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Regulatory Toxicology and Pharmacology

17 August 2017

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17 August 2017

50

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2-22

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1

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Meningoencephalitis and demyelination are pathologic manifestations of primary polyomavirus infection in immunosuppressed rhesus monkeys

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A critical review of the optimum duration of chronic rodent testing for the determination of non-tumourigenic toxic potential: a report by the BTS Working Party on Duration of Toxicity Testing

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The duration of non-rodent toxicity studies for pharmaceuticals. International Conference on Harmonication (ICH).

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Immune and inflammatory responses in TNF alpha-deficient mice: a critical requirement for TNF alpha in the formation of primary B cell follicles, follicular dendritic cell networks and germinal centers, and in the maturation of the humoral immune re

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Preclinical safety evaluation of rhuMAbVEGF, an antiangiogenic humanized monoclonal antibody

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The role of amphiregulin in breast cancer.

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Association of simian virus 40 with a central nervous system lesion distinct from progressive multifocal leukoencephalopathy in macaques with AIDS.

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The use of dogs as second species in regulatory testing of pesticides. Part II: Subacute, subchronic and chronic studies in the dog.

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Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1-34) for 2 years and relevance to human safety

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Untangling the ErbB signalling network

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10.1016/J.YRTPH.2007.08.001

7 January 2021

Identifiers

DOI

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17 August 2017

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