دانلود کتاب سم شناسی کشف دارو: از ارزیابی هدف تا ترجمه بیومارکرها
Drug Discovery Toxicology: From Target Assessment to Translational Biomarkers, 1ed

As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process.

• Guides researchers as to what drug safety experiments are both practical and useful
• Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools
• Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods
• Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

From the Back Cover

Developing novel pharmaceuticals requires nonclinical safety studies on candidate drugs to assess general toxicology (through in vivo experiments), safety pharmacology (effects on major organ systems), and genetic toxicity tests. These data provide risk assessment data that supports progression of candidate drugs from discovery phase through clinical development, to regulatory submission and registration. Traditionally, however, less emphasis was placed on the evaluation of safety issues for projects while still in the drug design phase.

In response to this costly attrition, many pharmaceutical companies invested in “drug discovery toxicology” or “drug discovery safety” to identify hazards and take steps to design out or significantly reduce undesirable safety liabilities earlier; with the ultimate aim of enhancing the probability of success in non-clinical and clinical drug development. Because of this, there is a strong need for personnel involved with toxicology and pharmacology studies need to understand the varied tools and approaches to perform early drug discovery safety analysis.

Drug Discovery Toxicology: From Target Assessment to Translational Biomarkers serves as a valuable tool for those discovery scientists. The authors, writing from firsthand industry experience, give readers insight into the strategy and execution of predictive toxicology practices, including what experiments are possible and useful. In addition, they offer a view into the future, indicating key areas to watch for new predictive methods. Broken into different sections, the book deals with the key topics – Safety Lead Optimization Strategies, In Vitro-In Vivo Pharmacokinetics Translation, Predicting Organ Toxicity In Vitro, False Negative Space, –Omics in Predictive Toxicology, Translational Biomarkers, and Signal Investigation Rationale and Practices.

About the Author

Yvonne Will, PhD, is a Senior Director and the Head of Science and Technology Strategy, Drug Safety Research and Development at Pfizer, Connecticut, USA. She co-edited the book Drug-Induced Mitochondrial Dysfunction, published by Wiley in 2008.

J. Eric McDuffie, PhD, is the Director of the Discovery / Investigative Toxicology and Laboratory Animal Medicine groups at Janssen Research & Development, California, USA.

Andrew J. Olaharski, PhD, is an Associate Director of Toxicology at Agios Pharmaceuticals, Massachusetts, USA.

Brandon D. Jeffy, PhD, is a Senior Principal Scientist in the Exploratory Toxicology division of Nonclinical Development at Celgene Pharmaceuticals, California, USA.

CHAPTER 1 EMERGING TECHNOLOGIES AND THEIR ROLE IN REGULATORY REVIEW
CHAPTER 2 SMALL-MOLECULE SAFETY LEAD OPTIMIZATION
CHAPTER 3 SAFETY ASSESSMENT STRATEGIES AND PREDICTIVE SAFETY OF BIOPHARMACEUTICALS AND ANTIBODY DRUG CONJUGATES
CHAPTER 4 DISCOVERY AND DEVELOPMENT STRATEGIES FOR SMALL INTERFERING RNAS
CHAPTER 5 PHYSICOCHEMISTRY AND THE OFF-TARGET EFFECTS OF DRUG MOLECULES
CHAPTER 6 THE NEED FOR HUMAN EXPOSURE PROJECTION IN THE INTERPRETATION OF PRECLINICAL IN VITRO AND IN VIVO ADME TOX DATA
CHAPTER 7 ADME PROPERTIES LEADING TO TOXICITY
CHAPTER 8 LIVER
CHAPTER 9 CARDIAC
CHAPTER 10 PREDICTIVE IN VITRO MODELS FOR ASSESSMENT OF NEPHROTOXICITY AND DRUG-DRUG INTERACTIONS IN VITRO
CHAPTER 11 PREDICTING ORGAN TOXICITY IN VITRO: BONE MARROW
CHAPTER 12 PREDICTING ORGAN TOXICITY IN VITRO: DERMAL TOXICITY
CHAPTER 13 IN VITRO METHODS IN IMMUNOTOXICITY ASSESSMENT
CHAPTER 14 STRATEGIES AND ASSAYS FOR MINIMIZING RISK OF OCULAR TOXICITY DURING EARLY DEVELOPMENT OF SYSTEMICALLY ADMINISTERED DRUGS
CHAPTER 15 PREDICTING ORGAN TOXICITY IN VIVO-CENTRAL NERVOUS SYSTEM
CHAPTER 16 BIOMARKERS, CELL MODELS, AND IN VITRO ASSAYS FOR GASTROINTESTINAL TOXICOLOGY
CHAPTER 17 PRECLINICAL SAFETY ASSESSMENT OF DRUG CANDIDATE-INDUCED PANCREATIC TOXICITY: FROM AN APPLIED PERSPECTIVE
CHAPTER 18 ANIMAL MODELS OF DISEASE FOR FUTURE TOXICITY PREDICTIONS
CHAPTER 19 THE USE OF GENETICALLY MODIFIED ANIMALS IN DISCOVERY TOXICOLOGY
CHAPTER 20 MOUSE POPULATION -BASED TOXICOLOGY FOR PERSONALI ZED MEDICINE AND IMPROVED SAFETY PREDICTION
CHAPTER 21 APPLICATION OF PLURIPOTENT STEM CELLS IN DRUG-INDUCED LIVER INJURY SAFETY ASSESSMENT
CHAPTER 22 HUMAN PLURIPOTENT STEM CELL-DERIVED CARDIOMYOCYTES: A NEW PARADIGM IN PREDICTIVE PHARMACOLOGY AND TOXICOLOGY
CHAPTER 23 STEM CELL-DERIVED RENAL CELLS AND PREDICTIVE RENAL IN VITRO MODELS
CHAPTER 24 PREDICTIVE CARDIAC HYPERTROPHY BIOMARKERS IN NONCLINICAL STUDIES
CHAPTER 25 VASCULAR INJURY BIOMARKERS
CHAPTER 26 NOVEL TRANSLATIONAL BIOMARKERS OF SKELETAL MUSCLE INJURY
CHAPTER 27 TRANSLATIONAL MECHANISTIC BIOMARKERS AND MODELS FOR PREDICTING DRUG-INDUCED LIVER INJURY: CLINICAL TO IN VITRO PERSPECTIVES
CHAPTER 28 ASSESSING AND PREDICTING DRUG-INDUCED KIDNEY INJURY, FUNCTIONAL CHANGE, AND SAFETY IN PRECLINICAL STUDIES IN RATS
CHAPTER 29 CANINE KIDNEY SAFETY PROTEIN BIOMARKERS
CHAPTER 30 TRADITIONAL KIDNEY SAFETY PROTEIN BIOMARKERS AND NEXT-GENERATION DRUG-INDUCED KIDNEY INJURY BIOMARKERS IN NONHUMAN PRIMATES
CHAPTER 31 RAT KIDNEY MICRORNA ATLAS
CHAPTER 32 MICRORNAS AS NEXT-GENERATION KIDNEY TUBULAR INJURY BIOMARKERS IN RATS
CHAPTER 33 MICRORNAS AS NOVEL GLOMERULAR INJURY BIOMARKERS IN RATS
CHAPTER 34 INTEGRATING NOVEL IMAGING TECHNOLOGIES TO INVESTIGATE DRUG-INDUCED KIDNEY TOXICITY
CHAPTER 35 IN VITRO TO IN VIVO RELATIONSHIPS WITH RESPECT TO KIDNEY SAFETY BIOMARKERS
CHAPTER 36 CASE STUDY: FULLY AUTOMATED IMAGE ANALYSIS OF PODOCYTE INJURY BIOMARKER EXPRESSION IN RATS
CHAPTER 37 CASE STUDY: NOVEL RENAL BIOMARKERS TRANSLATION TO HUMANS
CHAPTER 38 CASE STUDY: MICRORNAS AS NOVEL KIDNEY INJURY BIOMARKERS IN CANINES
CHAPTER 39 NOVEL TESTICULAR INJURY BIOMARKERS
CHAPTER 40 BEST PRACTICES IN PRECLINICAL BIOMARKER SAMPLE COLLECTIONS
CHAPTER 41 BEST PRACTICES IN NOVEL BIOMARKER ASSAY FIT-FOR-PURPOSE TESTING
CHAPTER 42 BEST PRACTICES IN EVALUATING NOVEL BIOMARKER FIT FOR PURPOSE AND TRANSLATABILITY
CHAPTER 43 BEST PRACTICES IN TRANSLATIONAL BIOMARKER DATA ANALYSIS
CHAPTER 44 TRANSLATABLE BIOMARKERS IN DRUG DEVELOPMENT: REGULATORY ACCEPTANCE AND QUALIFICATION
CHAPTER 45 TOXICOGENOMICS IN DRUG DISCOVERY TOXICOLOGY: HISTORY, METHODS, CASE STUDIES, AND FUTURE DIRECTIONS
CHAPTER 46 ISSUE INVESTIGATION AND PRACTICES IN DISCOVERY TOXICOLOGY

قیمت : 5000 تومان

لینک کوتاه : https://bookbaz.ir/?p=34070
نویسنده : Yvonne Will , J. Eric McDuffie
ناشر : Wiley; 1 edition
سال انتشار : 2016
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 601
(ISBN) شابک : 1119053331
قیمت کتاب درآمازون : $176.22
حجم فایل : 12 MB

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دانلود کتاب سم شناسی کشف دارو: از ارزیابی هدف تا ترجمه بیومارکرهاDrug Discovery Toxicology: From Target Assessment to Translational Biomarkers, 1ed

From the Back Cover

About the Author

Contents

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دانلود کتاب سم شناسی کشف دارو: از ارزیابی هدف تا ترجمه بیومارکرها
Drug Discovery Toxicology: From Target Assessment to Translational Biomarkers, 1ed