Regulatory forum opinion piece*: tissue cross-reactivity studies: what constitutes an adequate positive control and how do we report positive staining?

Geoly, Frank J

Geoly, Frank J.

Affiliation

Geoly FJ; Drug Safety Research & Development, Pfizer Worldwide Research & Development, Groton, Connecticut, USA frank.j.geoly@pfizer.com.

Toxicol Pathol ; 42(6): 954-6, 2014 Aug.

Article in En | MEDLINE | ID: mdl-23847038

Subject(s)

Drug Evaluation, Preclinical/standards; Immunohistochemistry/standards; Risk Assessment/standards; Animals; Antibodies, Monoclonal; Cross Reactions; Drug Evaluation, Preclinical/methods; Humans; Immunohistochemistry/methods; Models, Biological; Risk Assessment/methods

Key words

commentary.; immunohistochemistry methods; interpretation; regulatory affairs; safety assessment; tissue cross-reactivity

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Immunohistochemistry / Risk Assessment / Drug Evaluation, Preclinical Type of study: Etiology_studies / Prognostic_studies / Risk_factors_studies Limits: Animals / Humans Language: En Journal: Toxicol Pathol Year: 2014 Type: Article Affiliation country: United States

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