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Drug Discovery and Development, 3rd Edition. Technology in Transition

Raymond G Hill, Duncan Richards
ISBN: 9780702078040
ISBN: 9780702078040
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Διαστάσεις 24 × 19 cm
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Περιγραφή

Essential insight into drug development and the pharmaceutical industryWith unprecedented interest in the power that the modern therapeutic armamentarium has to combat disease, the new edition of Drug Discovery and Development is an essential resource for anyone interested in understanding how drugs and other therapeutic interventions are discovered and developed, through to clinical research, registration, and market access.

The text has been thoroughly updated, with new information on biopharmaceuticals and vaccines as well as clinical development and target identification. Drug discovery and development continues to evolve rapidly and this new edition reflects important changes in the landscape.

Edited by industry experts Raymond Hill and Duncan Richards, this market-leading text is suitable for undergraduates and graduates undertaking degrees in pharmacy, pharmacology, toxicology, and clinical development through to those embarking on a career in the pharmaceutical industry.

Key Features
  • Key stages of drug discovery and development
  • Chapters outline the contribution of individual disciplines to the overall process
  • Supplemented by specific chapters on different modalities
  • Includes coverage of Oligonucleotide therapies; cell and gene therapy
  • Now comes with online access on StudentConsult
Author Information
Edited by Raymond G Hill, President, British Pharmacological Society, London, UK and Duncan Richards, Professor Duncan Richards MA DM FRCP FFPM FBPharmacolS, St Hilda’s College,Oxford

Περιεχόμενα

  • Cover image
  • Title page
  • Table of Contents
  • Copyright
  • Preface to 3rd edition
  • Preface to 2nd edition
  • Preface to 1st edition
  • Contributors
  •     List of Tables
  •     List of Illustrations
  • Section 1. Introduction and background
  • 1.  The development of the pharmaceutical industry
  •     Antecedents and origins
  •     Therapeutics in the 18th–19th centuries
  •     An industry begins to emerge
  •     Concluding remarks
  •     References
  • 2.  The nature of disease and the purpose of therapy
  •     Introduction
  •     Concepts of disease
  •     The aims of therapeutics
  •     Function and dysfunction: The biological perspective
  •     Therapeutic interventions
  •     Measuring therapeutic outcome
  •     Pharmacoepidemiology and pharmacoeconomics
  •     Summary
  •     References
  • 3.  Therapeutic modalities
  •     Introduction
  •     The range of therapeutic interventions
  •     Conventional therapeutic drugs
  •     Biological products
  •     Gene therapy
  •     Other therapeutic approaches
  •     Summary
  •     Further reading
  •     Classic papers on phage display
  •     Nucleotide therapy for neurodegenerative disease
  •     A forward look for CAR-T therapy
  •     Gene therapy overview
  •     CRISPR review
  • Section 2. Drug discovery
  • 4.  Target selection
  •     Introduction
  •     General characteristics of drug targets
  •     Target identification
  •     Use of genetics for target identification
  •     Expression data of the target in tissues
  •     Utilizing systematic literature searches to identify new targets
  •     Tractability assessment
  •     Experimental validation of potential new targets
  •     Understanding target mechanism of action
  •     Clinical context
  •     References
  • 5.  From drug target to drug discovery
  •     Introduction
  •     Key project selection criteria
  •     Target product profile
  •     Planning the project
  •     Assay development
  •     Hit/lead identification
  •     Lead optimization
  •     Target validation and biological studies
  • 6.  High-throughput screening
  •     Introduction: A historical and future perspective
  •     Lead discovery and high-throughput screening
  •     Screening libraries and compound logistics
  •     Profiling
  •     References
  • 7.  The role of medicinal chemistry in the drug discovery process
  •     Introduction
  •     Target selection and validation
  •     Lead identification/generation
  •     Lead optimization
  •     Addressing attrition
  •     Summary
  •     References
  • 8.  Therapeutic antibodies
  •     Introduction:
  •     Therapeutic antibody discovery
  •     Antibody fragments, bispecific and alternative formats
  •     Manufacture, biological and biophysical assessment of therapeutic antibodies
  •     Future perspective
  •     References
  • 9.  Emerging modalities: Nucleotide-based therapies, cell-based therapies, gene therapy
  •     Introduction
  •     Antisense oligonucleotides and small interfering RNA
  •     Approved oligonucleotide drugs
  •     Cell therapy
  •     TCR-T and CAR T-cell manufacture
  •     TCR-T and CAR T-cell clinical trial outcomes
  •     Gene therapy
  •     Conclusions
  •     References
  • 10.  Metabolism and pharmacokinetic optimization strategies in drug discovery
  •     Introduction
  •     Optimization of DMPK properties
  •     Absorption and oral bioavailability
  •     Avoidance of PK-based drug–drug interactions
  •     Central nervous system
  •     Clearance optimization
  •     Optimization of metabolic clearance
  •     Optimization of renal clearance
  •     Optimization of biliary clearance
  •     Cautions
  •     Role of metabolite identification studies in optimization
  •     Active metabolites
  •     Tactics
  •     Minimizing risk for reactive metabolites during drug discovery
  •     Human pharmacokinetics and dose prediction
  •     Summary
  •     Acknowledgements
  •     References
  • 11.  Pharmacology
  •     Introduction
  •     Overview
  •     Pharmacological evaluation
  •     Pharmacological profiling in vitro
  •     Good laboratory practice compliance in pharmacological studies
  •     Pharmacology in the development phase
  •     Modelling and simulation and model-based drug development
  •     References
  • 12.  Nonclinical safety assessment
  •     Nonclinical package to support first-in-human studies
  •     Primary and secondary pharmacology
  •     Safety pharmacology
  •     Toxicology
  •     Special tests
  •     Reproductive toxicology
  •     Carcinogenicity
  •     Toxicology studies to support use in children
  •     Specific considerations for biopharmaceuticals and advanced therapies
  •     The future—new approaches in translational toxicology
  •     References
  •     Further reading
  • 13.  Therapeutic vaccines
  •     Introduction
  •     Vectors, adjuvants and delivery systems
  •     Therapeutic vaccines for infectious diseases
  •     Therapeutic cancer vaccines
  •     Therapeutic vaccines for other chronic diseases
  •     References
  • Section 3. Drug development
  • 14.  An introduction to drug development
  •     Introduction
  •     The nature of drug development
  •     Components of drug development
  •     The interface between discovery and development
  •     Decision points
  •     The need for improvement
  •     Further reading
  • 15.  Clinical assessment of safety
  •     Safety assessment in early clinical trials
  •     Phase II
  •     Phase III studies
  •     The summary of product characteristics
  •     Postmarketing surveillance
  •     Further reading
  • 16.  Pharmaceutical development
  •     Introduction
  •     Preformulation studies
  •     Routes of administration and dosage forms
  •     Formulation
  •     Principles of drug delivery systems
  •     Summary
  •     References
  • 17.  Clinical development
  •     Introduction
  •     Question-based drug development
  •     Phase I: Clinical pharmacology
  •     Phase II studies
  •     Phase III development
  •     Phase IV
  •     Paediatric drug development
  •     Phase 0 (microdose) studies
  •     The future and adaptive pathways
  •     Further reading
  • 18.  Clinical imaging in drug development
  •     Introduction
  •     Imaging methods
  •     Human target validation
  •     Biodistribution
  •     Target interaction
  •     Pharmacodynamics
  •     Early phase development
  •     Patient stratification and precision medicine
  •     Imaging as a surrogate marker
  •     Imaging in the real world—challenges to implementation
  •     Summary
  •     References
  • 19.  Intellectual property in drug discovery and development
  •     What is a patent?
  •     The patent specification
  •     What can be patented?
  •     Requirements for patentability
  •     Patent issues in drug discovery
  •     The state of the art
  •     Patent documents as state of the art
  •     Evaluation by the patent professional
  •     Sources of information
  •     Results of the evaluation—new chemical entities
  •     Obtaining patent protection for a development compound
  •     Further reading
  •     Useful websites
  •     Patent offices
  •     Professional organizations
  •     Lists of links
  • 20.  Regulatory affairs
  •     Introduction
  •     Brief history of pharmaceutical regulation
  •     International harmonization
  •     Roles and responsibilities of health authority, regulatory authority and company
  •     The drug development process
  •     Regulatory procedures
  •     Administrative rules
  •     List of abbreviations
  •     References
  •     Website references
  • 21.  The role of pharmaceutical marketing
  •     Introduction
  •     Pharmaceutical marketing—background
  •     Product life cycle
  •     Pharmaceutical product life cycle (fig. 21.2)
  •     Traditional pharmaceutical marketing
  •     Market access
  •     Pricing
  •     Risk and uncertainty
  •     Managed entry agreements
  •     Changing environment—changing marketing
  •     The future of marketing
  •     References
  • Section 4. Facts and figures
  • 22.  Drug discovery and development: The future?
  •     Recent advances in technology
  •     Spending
  •     Sales revenues
  •     Timelines
  •     Pipelines and attrition rates
  •     Biotechnology-derived medicines
  •     Recent introductions
  •     Predicting the future?
  •     References
  • Index

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