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Global New Drug Development : An Introduction

By: Rosier, Jan A.
Contributor(s): Martens, Mark A | Thomas, Josse R.
Material type: TextTextSeries: eBooks on Demand.Postgraduate Pharmacy Series: Publisher: Hoboken : Wiley, 2014Edition: 1.Description: 1 online resource (427 p.).ISBN: 9781118414866.Subject(s): Drugs -- Law and legislation | Food and drug administration | Pharmaceutical industry | Pharmaceutical policyGenre/Form: Electronic books.Additional physical formats: Print version:: Global New Drug Development : An IntroductionDDC classification: 615.19 Online resources: Click here to view this ebook.
Contents:
Cover; Title Page; Copyright; Contents; Series Foreword; Preface; Acknowledgements; Abbreviations; Introduction; Chapter 1 Drug Life Cycle; 1.1 Introduction; 1.2 Drivers of the search for a new drug; 1.2.1 Strategic criteria; 1.2.2 Scientific and technical criteria; 1.2.3 Operational criteria; 1.3 Structure of a drug life cycle; 1.4 Costs and risks of drug research and development; 1.4.1 Cost drivers; 1.4.2 Estimates of drug development costs; 1.5 Risks of drug R&D; 1.5.1 Failure and success rates in drug development; 1.5.2 Net present value; 1.6 Value for patient and society
1.7 The end of a drug's life1.8 Management; References; Chapter 2 Drug Discovery and Design; 2.1 Introduction; 2.2 Approaches in drug discovery; 2.2.1 Phenotypic based; 2.2.2 Target based; 2.2.3 Molecular drug design; 2.3 The drug discovery process; 2.3.1 Exploratory phase; 2.3.2 Assay development; 2.3.3 Screening; 2.3.4 Hit-to-lead; 2.3.5 Lead optimisation; References; Chapter 3 Drug Development: General Aspects; 3.1 Introduction; 3.2 The objective of drug development; 3.3 Drug development organisations and teams; 3.4 Drug development streams; 3.4.1 Chemical and pharmaceutical development
3.4.2 Nonclinical development3.4.3 Clinical development; 3.4.4 Interaction between the development streams; 3.5 Phases in drug development; 3.5.1 Early development; 3.5.2 Late development; 3.5.3 Milestones in drug development; 3.6 Regulatory environment; 3.6.1 Legislation and guidelines; 3.6.2 Regulatory authorities and organisations; 3.6.3 Regulatory processes and documents; 3.7 Quality management; 3.7.1 General principles; 3.7.2 Good Practices; 3.7.3 Standard Operating Procedures (SOP); 3.7.4 Quality control; 3.7.5 Audits and inspections; 3.7.6 Quality risk management
3.8 Project risk management3.8.1 Nature of risk; 3.8.2 Types of risk; 3.8.3 Analysis of risk and `show stoppers'; 3.9 Ethical considerations; 3.9.1 General aspects; 3.9.2 Use of experimental animals; 3.9.3 Experiments involving human subjects; 3.10 The global nature of drug development; References; Chapter 4 Methods and Techniques Used in Drug Development; 4.1 Introduction; 4.2 Chemical and pharmaceutical development; 4.2.1 Physicochemical characterisation of the active ingredient; 4.2.2 Formulation of the active ingredient
4.2.3 Determination of the quality of the active ingredient and the drug product4.3 Nonclinical development; 4.3.1 Pharmacokinetics; 4.3.2 Safety pharmacology; 4.3.3 Toxicology; 4.4 Clinical development; 4.4.1 Pharmacometrics; 4.4.2 Biomarkers; 4.4.3 Imaging techniques; 4.4.4 Human electrocardiography; 4.4.5 Clinical trial methodology; 4.4.6 Organisational challenges in clinical drug trials; References; Chapter 5 The Early Development of a New Drug; 5.1 Introduction; 5.2 Pre-clinical phase; 5.2.1 Chemical and pharmaceutical development; 5.2.2 Nonclinical development
5.2.3 Clinical development
Summary: The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. "This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University…. I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book.. (and, therefore)… this book could not be more timely. " Professor Mike Coleman, University of Aston., UK ( from his review of the final manuscript)   
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Item type Current location Call number URL Status Date due Barcode
Electronic Book UT Tyler Online
Online
RA644.A25 .R95 2014 (Browse shelf) http://uttyler.eblib.com/patron/FullRecord.aspx?p=1729063 Available EBL1729063

Cover; Title Page; Copyright; Contents; Series Foreword; Preface; Acknowledgements; Abbreviations; Introduction; Chapter 1 Drug Life Cycle; 1.1 Introduction; 1.2 Drivers of the search for a new drug; 1.2.1 Strategic criteria; 1.2.2 Scientific and technical criteria; 1.2.3 Operational criteria; 1.3 Structure of a drug life cycle; 1.4 Costs and risks of drug research and development; 1.4.1 Cost drivers; 1.4.2 Estimates of drug development costs; 1.5 Risks of drug R&D; 1.5.1 Failure and success rates in drug development; 1.5.2 Net present value; 1.6 Value for patient and society

1.7 The end of a drug's life1.8 Management; References; Chapter 2 Drug Discovery and Design; 2.1 Introduction; 2.2 Approaches in drug discovery; 2.2.1 Phenotypic based; 2.2.2 Target based; 2.2.3 Molecular drug design; 2.3 The drug discovery process; 2.3.1 Exploratory phase; 2.3.2 Assay development; 2.3.3 Screening; 2.3.4 Hit-to-lead; 2.3.5 Lead optimisation; References; Chapter 3 Drug Development: General Aspects; 3.1 Introduction; 3.2 The objective of drug development; 3.3 Drug development organisations and teams; 3.4 Drug development streams; 3.4.1 Chemical and pharmaceutical development

3.4.2 Nonclinical development3.4.3 Clinical development; 3.4.4 Interaction between the development streams; 3.5 Phases in drug development; 3.5.1 Early development; 3.5.2 Late development; 3.5.3 Milestones in drug development; 3.6 Regulatory environment; 3.6.1 Legislation and guidelines; 3.6.2 Regulatory authorities and organisations; 3.6.3 Regulatory processes and documents; 3.7 Quality management; 3.7.1 General principles; 3.7.2 Good Practices; 3.7.3 Standard Operating Procedures (SOP); 3.7.4 Quality control; 3.7.5 Audits and inspections; 3.7.6 Quality risk management

3.8 Project risk management3.8.1 Nature of risk; 3.8.2 Types of risk; 3.8.3 Analysis of risk and `show stoppers'; 3.9 Ethical considerations; 3.9.1 General aspects; 3.9.2 Use of experimental animals; 3.9.3 Experiments involving human subjects; 3.10 The global nature of drug development; References; Chapter 4 Methods and Techniques Used in Drug Development; 4.1 Introduction; 4.2 Chemical and pharmaceutical development; 4.2.1 Physicochemical characterisation of the active ingredient; 4.2.2 Formulation of the active ingredient

4.2.3 Determination of the quality of the active ingredient and the drug product4.3 Nonclinical development; 4.3.1 Pharmacokinetics; 4.3.2 Safety pharmacology; 4.3.3 Toxicology; 4.4 Clinical development; 4.4.1 Pharmacometrics; 4.4.2 Biomarkers; 4.4.3 Imaging techniques; 4.4.4 Human electrocardiography; 4.4.5 Clinical trial methodology; 4.4.6 Organisational challenges in clinical drug trials; References; Chapter 5 The Early Development of a New Drug; 5.1 Introduction; 5.2 Pre-clinical phase; 5.2.1 Chemical and pharmaceutical development; 5.2.2 Nonclinical development

5.2.3 Clinical development

The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. "This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University…. I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book.. (and, therefore)… this book could not be more timely. " Professor Mike Coleman, University of Aston., UK ( from his review of the final manuscript)   

Description based upon print version of record.

Author notes provided by Syndetics

<p> Jan A. Rosier , Professor, Faculty of Pharmaceutical Sciences, University of Leuven/Cranfield, School of Management.</p> <p> Mark Martens , Belgium; Toxicologist.</p> <p> Josse Thomas , Belgium; Guest Profrssor Leuven and Université de Liège, Belgium).</p>

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