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MOLECULAR HISTOPATHOLOGY AND TISSUE BIOMARKERS IN DRUG AND DIAGNOSTIC DEVELOPMENT

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9781493954209 ::  MOLECULAR HISTOPATHOLOGY AND TISSUE BIOMARKERS IN DRUG AND DIAGNOSTIC DEVELOPMENT
ISBN:

9781493954209

Collection:METHODS IN PHARMACOLOGY AND TOXICOLOGY
Publisher:SPRINGER NATURE
Edition:
Pages:375
Language:INGLES
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<P><I>MOLECULAR HISTOPATHOLOGY AND TISSUE BIOMARKERS IN DRUG AND DIAGNOSTIC DEVELOPMENT</I> GATHERS DIVERSE EXPERTS TO PRESENT STATE OF THE ART GUIDANCE AND APPLICATION OF HISTOPATHOLOGY IN DRUG DEVELOPMENT SETTINGS RANGING FROM DISCOVERY RESEARCH TO HUMAN CLINICAL TRIALS. WHILE MANY CURRENT APPLICATIONS OF QUANTITATIVE HISTOLOGY AND MOLECULAR PATHOLOGY IN THE BIOPHARMACEUTICAL INDUSTRY ARE FOCUSED ON ONCOLOGY, THIS VOLUME IN ADDITION EXPLORES NON-ONCOLOGIC DISEASE AREAS INCLUDING NONALCOHOLIC STEATOHEPATITIS, ARTHRITIS, CELIAC DISEASE, MYELOPROLIFERATIVE DISORDERS, NEUROLOGY, AND WOUND HEALING. THE AUTHORS WRITE FROM YEARS OF EXPERIENCE IN DIAGNOSTIC PRACTICE AND PHARMACEUTICAL DRUG DEVELOPMENT, AIMING TO EDUCATE PHARMACEUTICAL AND ACADEMIC SCIENTISTS HOW TO BEST USE TISSUE TO DIAGNOSE DISEASE AND IMPROVE THE PROCESS OF DRUG DEVELOPMENT.  AS PART OF THE <I>METHODS IN PHARMACOLOGY AND TOXICOLOGY</I> SERIES, THIS VOLUME IS DESIGNED TO PROVIDE WISDOM AND EXAMPLES THAT OTHERS CAN FOLLOW AND APPLY AS PART OF DRUG DEVELOPMENT.</P><P>COMPREHENSIVE AND PRACTICAL, <I>MOLECULAR HISTOPATHOLOGY AND TISSUE BIOMARKERS IN DRUG AND DIAGNOSTIC DEVELOPMENT</I> WILL INFORM AND ENLIGHTEN BOTH TISSUE-FOCUSED AND NON-TISSUE-FOCUSED DRUG DEVELOPMENT PROFESSIONALS ABOUT BETTER USE AND INTERPRETATION OF THE MULTIDIMENSIONAL DATA CONTAINED IN A TISSUE BIOPSY.</P>

<P>PART I: CURRENT PERSPECTIVES ON THE PATHOLOGY DISCIPLINE IN THE PHARMA INDUSTRY</P><P> </P><P>1. HISTOPATHOLOGY: A CANVAS AND LANDSCAPE OF DISEASE IN DRUG AND DIAGNOSTIC DEVELOPMENT</P><P>            KEITH A. WHARTON, JR.</P><P> </P><P>2. A FIELD GUIDE TO <I>HOMO MORPHOLOGICUS</I> FOR BIOMEDICAL SCIENTISTS, OR HOW TO CONVEY AN UNDERSTANDING OF PATHOLOGY TO SCIENTISTS IN A BIOPHARMA ENTERPRISE</P><P>            HUMPHREY GARDNER</P><P> </P><P>3. OUTSOURCING TISSUE HISTOPATHOLOGY INVESTIGATIONS IN SUPPORT OF CLINICAL TRIALS FOR NOVEL THERAPEUTICS: CONSIDERATIONS AND PERSPECTIVES</P><P>            KEITH A. WHARTON, JR., BENJAMIN H. LEE, PIERRE MOULIN, DALE MONGEON, RAINER HILLENBRAND, ARKADY GUSEV, BIN YE, AND XIAOYU JIANG</P><P> </P><P>4. HISTOPATHOLOGY IN MOUSE MODELS OF RHEUMATOID ARTHRITIS</P><P>            PATRICK CAPLAZI AND LAURI DIEHL</P><P> </P><P>PART II: CURRENT DIRECTIONS IN HISTOPATHOLOGY FOR DRUG DEVELOPMENT, INVOLVING TISSUE IMAGE ANALYSIS</P><P> </P><P>5. MARKERS USED FOR VISUALIZATION AND QUANTIFICATION OF BLOOD VESSELS AND LYMPHATIC VESSELS</P><P>            MOHAMED E. SALAMA, DAVID A. EBERHARD, AND STEVEN J. POTTS</P><P> </P><P>6. PRACTICAL APPROACHES TO MICROVESSEL ANALYSIS: HOTSPOTS, MICROVESSEL DENSITY, AND VESSEL PROXIMITY</P><P>            STEVEN J. POTTS, DAVID A. EBERHARD, AND MOHAMED E. SALAMA</P><P> </P><P>7. QUANTITATIVE HISTOPATHOLOGY AND ALTERNATIVE APPROACHES TO ASSESSMENT OF FIBROSIS FOR DRUG DEVELOPMENT IN HEPATITIS C AND NONALCOHOLIC STEATOHEPATITIS</P><P>            STEVEN J. POTTS AND JOHANNA K. DISTEFANO</P><P> </P><P>8. STEREOLOGY AND COMPUTER-BASED IMAGE ANALYSIS QUANTIFIES HETEROGENEITY AND IMPROVES REPRODUCIBILITY FOR GRADING RETICULIN IN MYELOPROLIFERATIVE NEOPLASMS</P><P>            MOHAMED E. SALAMA, ERIK HAGENDORN, SHERRIE L. PERKINS, JEFF KUTOK, ETMAN A, JOSEF T. PRCHAL, AND STEVEN J. POTTS</P><P> </P><P>9. IMAGE ANALYSIS TOOLS FOR QUANTIFICATION OF SPINAL MOTOR NEURON SUBTYPE IDENTITIES</P><P>            MIRZA PELJTO AND HYNEK WICHTERLE</P><P> </P><P>10. DEVELOPMENT OF A TISSUE IMAGE ANALYSIS ALGORITHM FOR CELIAC DRUG DEVELOPMENT</P><P>            ERIK HAGENDORN, CHRISTA WHITNEY-MILLER, AARON HUBER, AND STEVEN J. POTTS</P><P> </P><P>11. QUANTITATIVE HISTOPATHOLOGY FOR EVALUATION OF IN VIVO BIOCOMPATIBILITY ASSOCIATED WITH BIOMEDICAL IMPLANTS</P><P>            ROBERT B. DILLER, ROBERT G. AUDET, AND ROBERT S. KELLAR</P><P> </P><P>12. QUANTITATIVE HISTOMORPHOMETRY AND QUANTITATIVE POLYMERASE CHAIN REACTION (PCR) AS ASSESSMENT TOOLS FOR PRODUCT DEVELOPMENT</P><P>            ROBERT G. AUDET, ROBERT B. DILLER, AND ROBERT S. KELLAR</P><P> </P><P>PART III: CURRENT DIRECTIONS IN HISTOPATHOLOGY FOR DRUG DEVELOPMENT, INVOLVING MOLECULAR HISTOPATHOLOGY: IN SITU HYBRIDIZATION</P><P> </P><P>13. MEASURING THE MESSENGER: RNA HISTOLOGY IN FORMALIN FIXED TISSUES</P><P>            STEVEN J. POTTS, MIRZA PELJTO, MAHIPAL SURANENI, AND JOSEPH S. KRUEGER</P><P> </P><P>14. ALGORITHM-DRIVEN IMAGE ANALYSIS SOLUTIONS FOR RNA ISH QUANTIFICATION IN HUMAN CLINICAL TISSUES</P><P>            MIRZA PELJTO, JOSEPH S. KRUEGER, NICHOLAS D. LANDIS, G. DAVID YOUNG, STEVEN J. POTTS, AND HOLGER LANGE</P><P> </P><P>15. SOLID TISSUE-BASED DNA ANALYSIS BY FISH IN RESEARCH AND MOLECULAR DIAGNOSTICS</P><P>            MARCUS OTTE</P><P> </P><P>PART III: CURRENT DIRECTIONS IN HISTOPATHOLOGY FOR DRUG DEVELOPMENT, INVOLVING MOLECULAR HISTOPATHOLOGY: SEQUENCING AND GENOMICS</P><P> </P><P>16. PREANALYTIC CONSIDERATIONS FOR MOLECULAR GENOMIC ANALYSES OF TISSUE</P><P>            MAUREEN CRONIN</P><P> </P><P>17. NEXT GENERATION SEQUENCING (NGS) IN ANATOMIC PATHOLOGY DISCOVERY AND PRACTICE</P><P>            MATTHEW J. MCGINNISS, DAVID A. EBERHARD, AND KEITH A. WHARTON, JR. </P><P> </P><P>PART IV: CURRENT DIRECTIONS IN HISTOPATHOLOGY FOR DRUG DEVELOPMENT, INVOLVING COMPANION DIAGNOSTICS</P><P> </P><P>18. THE IMPACT OF PRE-ANALYTIC VARIABLES ON TISSUE QUALITY FROM CLINICAL SAMPLES COLLECTED IN A ROUTINE CLINICAL SETTING: IMPLICATIONS FOR DIAGNOSTIC EVALUATION, DRUG DISCOVERY, AND TRANSLATIONAL RESEARCH</P><P>            DAVID G. HICKS</P><P> </P><P>19. ADAPTING HER2 TESTING FOR A DIFFERENT ORGAN: NEW WINE IN OLD WINESKINS</P><P>            MICHAEL D. LUNT AND CHRISTA L. WHITNEY-MILLER</P><P> </P><P>20. TISSUE-BASED COMPANION DIAGNOSTICS:  DEVELOPMENT OF IHC ASSAYS FROM AN INDUSTRY PERSPECTIVE</P><P>            MIU CHAU AND JON ASKAA</P><P> </P><P>21. DEVELOPMENT OF TISSUE-BASED COMPANION DIAGNOSTICS:  THE RELATIONSHIP BETWEEN THE PHARMACEUTICAL COMPANY, DIAGNOSTIC PARTNER, AND THE BIOMARKER LABORATORY</P><P>            MARK  KOCKX, STEFANIE DE SCHEPPER, AND CHRISTOPHER UNG</P><P> </P><P>22. NAVIGATING REGULATORY APPROVAL FOR TISSUE-BASED COMPANION DIAGNOSTICS</P><P>            JOSEPH S. KRUEGER, HOLGER LANGE, G. DAVID YOUNG, AND STEVEN J. POTTS</P><P> </P><P>23. IMPLEMENTING A MULTI-ANALYTE IMMUNOHISTOCHEMISTRY PANEL INTO A DRUG DEVELOPMENT PROGRAM</P><P>            CARLA HEISE, PIERRE BROUSSET, TOMMY FU, DAVID A. EBERHARD, GRAHAM W. SLACK, CAMILLE LAURENT, AND RANDY D. GASCOYNE</P><P> </P><P>24. CUTPOINT ANALYSIS AND RELATED STATISTICAL METHODS IN DIGITAL PATHOLOGY AND COMPANION DIAGNOSTICS</P><P>            JOSHUA C. BLACK, MAHIPAL V. SURANENI, AND STEVEN J. POTTS</P>

PHARMACOLOGY
TOXICOLOGY
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