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Toxicologic Pathology
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Molecular Pathology in the Preclinical Development of Biopharmaceuticals

Nancy A. Gillett

Sierra Biomedical, Inc., 587 Dunn Circle, Sparks, Nevada 89431, ngillett@ sierrabiomedical.com.

Curtis M. Chan

Sierra Biomedical, Inc., Sparks, Nevada

Advances in cell and molecular biology have engendered a wide range of techniques that can be used to study the molecular events that underlie the cause of disease, thus producing a new field of study called "molecular pathology." These techniques can be either slide-based or non-slide-based (solution-based). The slide-based techniques include immunohistochemistry, in situ hybridization, and in situ polymerase chain reaction; pathologists play a unique role in the administration of these techniques because of their ability to interpret the end product (i.e., the slide). In this manuscript, we briefly discussed the use and impact of these slide-based techniques within all phases of drug development in the pharmaceutical industry.

Key Words: Immunohistochemistry • in situ hybridization • polymerase chain reaction • in situ polymerase chain reaction • drug development

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Toxicologic Pathology, Vol. 27, No. 1, 48-52 (1999)
DOI: 10.1177/019262339902700110


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A. M. Pilling
The Role of the Toxicologic Pathologist in the Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Toxicol Pathol, November 1, 1999; 27(6): 678 - 688.
[Abstract] [PDF]


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