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Book Cover
E-book
Author Zhang, Donglu

Title ADME-Enabling Technologies in Drug Design and Development
Published Hoboken : John Wiley & Sons, 2012

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Description 1 online resource (1899 pages)
Contents Cover; Title page; Copyright page; FOREWORD; PREFACE; CONTRIBUTORS; PART A: ADME: OVERVIEW AND CURRENT TOPICS; 1 REGULATORY DRUG DISPOSITION AND NDA PACKAGE INCLUDING MIST; 1.1 INTRODUCTION; 1.2 NONCLINICAL OVERVIEW; 1.3 PK; 1.4 ABSORPTION; 1.5 DISTRIBUTION; 1.6 METABOLISM; 1.7 EXCRETION; 1.8 IMPACT OF METABOLISM INFORMATION ON LABELING; 1.9 CONCLUSIONS; 2 OPTIMAL ADME PROPERTIES FOR CLINICAL CANDIDATE AND INVESTIGATIONAL NEW DRUG (IND) PACKAGE; 2.1 INTRODUCTION; 2.2 NCE AND INVESTIGATIONAL NEW DRUG (IND) PACKAGE; 2.3 ADME OPTIMIZATION; 2.4 ADME OPTIMIZATION FOR CNS DRUGS; 2.5 SUMMARY
3 DRUG TRANSPORTERS IN DRUG INTERACTIONS AND DISPOSITION3.1 INTRODUCTION; 3.2 ABC TRANSPORTERS; 3.3 SLC TRANSPORTERS; 3.4 IN VITRO ASSAYS IN DRUG DEVELOPMENT; 3.5 CONCLUSIONS AND PERSPECTIVES; 4 PHARMACOLOGICAL AND TOXICOLOGICAL ACTIVITY OF DRUG METABOLITES; 4.1 INTRODUCTION; 4.2 ASSESSMENT OF POTENTIAL FOR ACTIVE METABOLITES; 4.3 ASSESSMENT OF THE POTENTIAL TOXICOLOGY OF METABOLITES; 4.4 SAFETY TESTING OF DRUG METABOLITES; 4.5 SUMMARY; 5 IMPROVING THE PHARMACEUTICAL PROPERTIES OF BIOLOGICS IN DRUG DISCOVERY: UNIQUE CHALLENGES AND ENABLING SOLUTIONS; 5.1 INTRODUCTION; 5.2 PHARMACOKINETICS
5.3 METABOLISM AND DISPOSITION5.4 IMMUNOGENICITY; 5.5 TOXICITY AND PRECLINICAL ASSESSMENT; 5.6 COMPARABILITY; 5.7 CONCLUSIONS; 6 CLINICAL DOSE ESTIMATION USING PHARMACOKINETIC/PHARMACODYNAMIC MODELING AND SIMULATION; 6.1 INTRODUCTION; 6.2 BIOMARKERS IN PK AND PD; 6.3 MODEL-BASED CLINICAL DRUG DEVELOPMENT; 6.4 FIRST-IN-HUMAN DOSE; 6.5 EXAMPLES; 6.6 DISCUSSION AND CONCLUSION; 7 PHARMACOGENOMICS AND INDIVIDUALIZED MEDICINE; 7.1 INTRODUCTION; 7.2 INDIVIDUAL VARIABILITY IN DRUG THERAPY; 7.3 WE ARE ALL HUMAN VARIANTS; 7.4 ORIGINS OF INDIVIDUAL VARIABILITY IN DRUG THERAPY
7.5 GENETIC POLYMORPHISM OF DRUG TARGETS7.6 GENETIC POLYMORPHISM OF CYTOCHROME P450s; 7.7 GENETIC POLYMORPHISM OF OTHER DRUG METABOLIZING ENZYMES; 7.8 GENETIC POLYMORPHISM OF TRANSPORTERS; 7.9 PHARMACOGENOMICS AND DRUG SAFETY; 7.10 WARFARIN PHARMACOGENOMICS: A MODEL FOR INDIVIDUALIZED MEDICINE; 7.11 CAN INDIVIDUALIZED DRUG THERAPY BE ACHIEVED?; 7.12 CONCLUSIONS; DISCLAIMER; CONTACT INFORMATION; 8 OVERVIEW OF DRUG METABOLISM AND PHARMACOKINETICS WITH APPLICATIONS IN DRUG DISCOVERY AND DEVELOPMENT IN CHINA; 8.1 INTRODUCTION; 8.2 PK-PD TRANSLATION RESEARCH IN NEW DRUG RESEARCH AND DEVELOPMENT
8.3 ABSORPTION, DISTRIBUTION, METABOLISM, EXCRETION, AND TOXICITY (ADME/T) STUDIES IN DRUG DISCOVERY AND EARLY STAGE OF DEVELOPMENT8.4 DRUG TRANSPORTERS IN NEW DRUG RESEARCH AND DEVELOPMENT; 8.5 DRUG METABOLISM AND PK STUDIES FOR NEW DRUG RESEARCH AND DEVELOPMENT; 8.6 STUDIES ON THE PK OF BIOTECHNOLOGICAL PRODUCTS; 8.7 STUDIES ON THE PK OF TCMs; 8.8 PK AND BIOAVAILABILITY OF NANOMATERIALS; PART B: ADME SYSTEMS AND METHODS; 9 TECHNICAL CHALLENGES AND RECENT ADVANCES OF IMPLEMENTING COMPREHENSIVE ADMET TOOLS IN DRUG DISCOVERY; 9.1 INTRODUCTION
9.2 "A" IS THE FIRST PHYSIOLOGICAL BARRIER THAT A DRUG FACES
Summary A comprehensive guide to cutting-edge tools in ADME researchThe last decade has seen tremendous progress in the development of analytical techniques such as mass spectrometry and molecular biology tools, resulting in important advances in drug discovery, particularly in the area of absorption, distribution, metabolism, and excretion (ADME). ADME-Enabling Technologies in Drug Design and Development focuses on the current state of the art in the field, presenting a comprehensive review of the latest tools for generating ADME data in drug discovery. It examines the broadest possible range of avai
Notes Print version record
Subject Science.
Science
sciences (philosophy)
SCIENCE -- Spectroscopy & Spectrum Analysis.
Science.
Form Electronic book
Author Surapaneni, Sekhar
ISBN 9781118180747
1118180747
9781118180761
1118180763