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Contents
- Front Matter
- Section 1 Discovery of new medicines
- Section 2 Medicines regulation
- Chapter 2.1 General principles of medicines regulation
- Chapter 2.2 Medicines regulation in the UK
- Chapter 2.3 Medicines regulation in the EU
- Chapter 2.4 The European Medicines Agency and Heads of Medicines Agencies
- Chapter 2.5 The European Directorate for the Quality of Medicines and HealthCare, European Pharmacopoeia, and British Pharmacopoeia
- Chapter 2.6 The Food and Drug Administration
- Chapter 2.7 Health Canada
- Chapter 2.8 Medsafe and the Therapeutic Goods Administration
- Chapter 2.9 Medicines regulation in Japan
- Chapter 2.10 Medicines regulation in China
- Chapter 2.11 Medical device regulation
- Chapter 2.12 Clinical trials regulation
- Chapter 2.13 Good clinical practice
- Chapter 2.14 Good laboratory practice and good clinical laboratory practice
- Chapter 2.15 Good manufacturing practice
- Chapter 2.16 The Ethics Committee (EU)
- Chapter 2.17 The Institutional Review Board (US)
- Chapter 2.18 Marketing authorization applications and updating and maintaining licences
- Chapter 2.19 The International Conference on Harmonisation
- Chapter 2.20 Common technical document
- Chapter 2.21 Medicinal product information in the European Union
- Chapter 2.22 Summary of product characteristics
- Chapter 2.23 Orphan drugs
- Chapter 2.24 Paediatric investigational plans
- Chapter 2.25 Regulatory requirements for pharmacovigilance
- Chapter 2.26 Overview of reporting of adverse drug reactions
- Chapter 2.27 Non-prescription drugs
- Chapter 2.28 Provision of unlicensed medicines
- Chapter 2.29 Reclassification of medicines
- Chapter 2.30 Parallel imports
- Section 3 Clinical pharmacology
- Chapter 3.1 Absorption, distribution, metabolism, and excretion
- Chapter 3.2 Volume of distribution, clearance, half-life
- Chapter 3.3 Pre-clinical aspects of pharmacokinetics
- Chapter 3.4 Non-clinical data
- Chapter 3.5 Clinical aspects of pharmacokinetics
- Chapter 3.6 Dose–response relationship
- Chapter 3.7 Proof of concept studies
- Chapter 3.8 Reproductive toxicity studies
- Chapter 3.9 Immunotoxicity testing
- Chapter 3.10 Carcinogenicity
- Chapter 3.11 Genotoxicity testing
- Chapter 3.12 Local tolerance
- Chapter 3.13 Acute toxicity
- Chapter 3.14 Studies: objectives, design, conduct, and analysis
- Chapter 3.15 Populations for exploratory studies and planning of exploratory studies
- Chapter 3.16 Pharmacodynamic endpoints
- Chapter 3.17 Bioavailability and bioequivalence
- Chapter 3.18 Evaluation of safety and tolerability
- Chapter 3.19 Hypersensitivity reactions
- Chapter 3.20 Drug–drug interactions
- Chapter 3.21 Ethics in research: basic principles, Declaration of Helsinki, and Council for International Organizations of Medical Sciences
- Chapter 3.22 Disease models
- Chapter 3.23 Biomarkers
- Chapter 3.24 Pharmacogenetics
- Chapter 3.25 Population pharmacokinetics
- Chapter 3.26 Small molecules and biologicals: safety and pharmacology requirements
- Section 4 Clinical development
- Chapter 4.1 Requirements for licensing a new medicinal product
- Chapter 4.2 Regulatory guidance
- Chapter 4.3 General principles of clinical trial protocols
- Chapter 4.4 Clinical study design
- Chapter 4.5 Adaptive trial designs
- Chapter 4.6 Informed consent
- Chapter 4.7 Data protection
- Chapter 4.8 Indemnity and compensation
- Chapter 4.9 Investigator's brochure
- Chapter 4.10 Organization of project teams/project planning
- Chapter 4.11 Contractual arrangements with research sites and contract research organizations
- Chapter 4.12 Case report form
- Chapter 4.13 Budgeting and cost control
- Chapter 4.14 Expanded access programmes
- Chapter 4.15 Study master file preparation
- Chapter 4.16 Target product profile
- Section 5 Statistics and data management
- Chapter 5.1 Determining the sample size in a clinical trial
- Chapter 5.2 Sensitivity and specificity
- Chapter 5.3 Significance testing
- Chapter 5.4 Type I and Type II error
- Chapter 5.5 Confidence intervals
- Chapter 5.6 Minimizing bias
- Chapter 5.7 Paired and unpaired t-tests
- Chapter 5.8 Parametric and non-parametric tests
- Chapter 5.9 Patient reported outcomes
- Chapter 5.10 Health-related quality of life
- Chapter 5.11 Clinical interpretation of trial results
- Chapter 5.12 Clinical study report
- Chapter 5.13 Issues with making trial results available
- Chapter 5.14 Interim analysis
- Chapter 5.15 Data management
- Chapter 5.16 Within trial data management
- Section 6 Drug safety and pharmacovigilance
- Chapter 6.1 Pharmacovigilance
- Chapter 6.2 Key pharmacovigilance regulations in the EU
- Chapter 6.3 Good pharmacovigilance practices
- Chapter 6.4 Periodic safety update reports
- Chapter 6.5 Benefit–risk assessment
- Chapter 6.6 Pharmacoepidemiological safety data
- Chapter 6.7 Product suspension and withdrawal and defective medicines
- Chapter 6.8 Safety signal
- Chapter 6.9 Spontaneous reporting
- Chapter 6.10 Post-authorization safety studies
- Chapter 6.11 Dear Healthcare Professional communication
- Chapter 6.12 Issues and crisis management
- Chapter 6.13 Adverse events in clinical trials
- Chapter 6.14 Risk management
- Section 7 Healthcare marketplace
- Chapter 7.1 Marketing medicines: the drug lifecycle
- Chapter 7.2 The Foreign Corrupt Practices Act and UK Bribery Act
- Chapter 7.3 Product lifecycle management
- Chapter 7.4 Ethical marketing of medicines
- Chapter 7.5 The World Health Organization ethical criteria for medicinal drug promotion
- Chapter 7.6 Co-marketing and co-promotion
- Chapter 7.7 In-licensing
- Chapter 7.8 The Association of British Pharmaceutical Industries
- Chapter 7.9 The Association of British Pharmaceutical Industries Code of Practice
- Chapter 7.10 Pharmaceutical Research and Manufacturers of America
- Chapter 7.11 The International Federation of Pharmaceutical Manufacturers & Associations Code of Practice
- Chapter 7.12 The European Federation of Pharmaceutical Industries and Associations
- Chapter 7.13 Medicines Australia
- Chapter 7.14 National Institute for Health and Clinical Excellence
- Chapter 7.15 The Scottish Intercollegiate Guidelines Network
- Chapter 7.16 The Institute for Quality and Efficiency in Health Care
- Chapter 7.17 Health economics
- Chapter 7.18 Quality-adjusted life years
- Chapter 7.19 Pharmacoepidemiology
- Chapter 7.20 Branded generics
- Chapter 7.21 Intellectual property
- Chapter 7.22 Product liability and compensation
- Section 8 Therapeutics
- End Matter