Pharmaceutical Medicine
Online ISBN:
9780191742774
Print ISBN:
9780199609147
Publisher:
Oxford University Press
Book
Pharmaceutical Medicine
Phil Ambery (ed.),
Phil Ambery
(ed.)
Director of Clinical Research, GlaxoSmithKline, and Honorary Clinical Fellow, Addenbrooke's Hospital, Cambridge
Find on
Daniel O'Connor (ed.)
Daniel O'Connor
(ed.)
Medical Assessor, Medical and Healthcare Products Regulatory Agency, UK
Find on
Published:
May 2013
Online ISBN:
9780191742774
Print ISBN:
9780199609147
Publisher:
Oxford University Press
Cite
Kilcoyne, Adrian, Phil Ambery, and Daniel O'Connor (eds), Pharmaceutical Medicine, Oxford Specialist Handbooks (Oxford , 2013; online edn, Oxford Academic, 1 July 2013), https://doi.org/10.1093/med/9780199609147.001.0001, accessed 22 Apr. 2024.
Abstract
With 136 chapters spread across 8 sections, this resource offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. It is a useful revision aid for exams as well as a starting point for areas of pharmaceutical medicine adjacent to a current role. It is a guiding hand in difficult situations as well as a rapid-access resource to the latest recommendations and guidelines.
Series
Oxford Specialist Handbooks
Collection:
Oxford Medicine Online
Disclaimer
Oxford University Press makes no representation, express or implied, that the drug dosages in this book are correct.
Readers must therefore always …
More
Oxford University Press makes no representation, express or implied, that the drug dosages in this book are correct.
Readers must therefore always check the product information and clinical procedures with the most up to date published product information and data sheets
provided by the manufacturers and the most recent codes of conduct and safety regulations. The authors and the publishers do not accept responsibility or
legal liability for any errors in the text or for the misuse or misapplication of material in this work. Except where otherwise stated, drug dosages
and recommendations are for the non-pregnant adult who is not breastfeeding.
Contents
-
Front Matter
-
Section 1 Discovery of new medicines
-
Section 2 Medicines regulation
-
2.1
General principles of medicines regulation
-
2.2
Medicines regulation in the UK
-
2.3
Medicines regulation in the EU
-
2.4
The European Medicines Agency and Heads of Medicines Agencies
-
2.5
The European Directorate for the Quality of Medicines and HealthCare, European Pharmacopoeia, and British Pharmacopoeia
-
2.6
The Food and Drug Administration
-
2.7
Health Canada
-
2.8
Medsafe and the Therapeutic Goods Administration
-
2.9
Medicines regulation in Japan
-
2.10
Medicines regulation in China
-
2.11
Medical device regulation
-
2.12
Clinical trials regulation
-
2.13
Good clinical practice
-
2.14
Good laboratory practice and good clinical laboratory practice
-
2.15
Good manufacturing practice
-
2.16
The Ethics Committee (EU)
-
2.17
The Institutional Review Board (US)
-
2.18
Marketing authorization applications and updating and maintaining licences
-
2.19
The International Conference on Harmonisation
-
2.20
Common technical document
-
2.21
Medicinal product information in the European Union
-
2.22
Summary of product characteristics
-
2.23
Orphan drugs
-
2.24
Paediatric investigational plans
-
2.25
Regulatory requirements for pharmacovigilance
-
2.26
Overview of reporting of adverse drug reactions
-
2.27
Non-prescription drugs
-
2.28
Provision of unlicensed medicines
-
2.29
Reclassification of medicines
-
2.30
Parallel imports
-
2.1
General principles of medicines regulation
-
Section 3 Clinical pharmacology
-
3.1
Absorption, distribution, metabolism, and excretion
-
3.2
Volume of distribution, clearance, half-life
-
3.3
Pre-clinical aspects of pharmacokinetics
-
3.4
Non-clinical data
-
3.5
Clinical aspects of pharmacokinetics
-
3.6
Dose–response relationship
-
3.7
Proof of concept studies
-
3.8
Reproductive toxicity studies
-
3.9
Immunotoxicity testing
-
3.10
Carcinogenicity
-
3.11
Genotoxicity testing
-
3.12
Local tolerance
-
3.13
Acute toxicity
-
3.14
Studies: objectives, design, conduct, and analysis
-
3.15
Populations for exploratory studies and planning of exploratory studies
-
3.16
Pharmacodynamic endpoints
-
3.17
Bioavailability and bioequivalence
-
3.18
Evaluation of safety and tolerability
-
3.19
Hypersensitivity reactions
-
3.20
Drug–drug interactions
-
3.21
Ethics in research: basic principles, Declaration of Helsinki, and Council for International Organizations of Medical Sciences
-
3.22
Disease models
-
3.23
Biomarkers
-
3.24
Pharmacogenetics
-
3.25
Population pharmacokinetics
-
3.26
Small molecules and biologicals: safety and pharmacology requirements
-
3.1
Absorption, distribution, metabolism, and excretion
-
Section 4 Clinical development
-
4.1
Requirements for licensing a new medicinal product
-
4.2
Regulatory guidance
-
4.3
General principles of clinical trial protocols
-
4.4
Clinical study design
-
4.5
Adaptive trial designs
-
4.6
Informed consent
-
4.7
Data protection
-
4.8
Indemnity and compensation
-
4.9
Investigator's brochure
-
4.10
Organization of project teams/project planning
-
4.11
Contractual arrangements with research sites and contract research organizations
-
4.12
Case report form
-
4.13
Budgeting and cost control
-
4.14
Expanded access programmes
-
4.15
Study master file preparation
-
4.16
Target product profile
-
4.1
Requirements for licensing a new medicinal product
-
Section 5 Statistics and data management
-
5.1
Determining the sample size in a clinical trial
-
5.2
Sensitivity and specificity
-
5.3
Significance testing
-
5.4
Type I and Type II error
-
5.5
Confidence intervals
-
5.6
Minimizing bias
-
5.7
Paired and unpaired t-tests
-
5.8
Parametric and non-parametric tests
-
5.9
Patient reported outcomes
-
5.10
Health-related quality of life
-
5.11
Clinical interpretation of trial results
-
5.12
Clinical study report
-
5.13
Issues with making trial results available
-
5.14
Interim analysis
-
5.15
Data management
-
5.16
Within trial data management
-
5.1
Determining the sample size in a clinical trial
-
Section 6 Drug safety and pharmacovigilance
-
6.1
Pharmacovigilance
-
6.2
Key pharmacovigilance regulations in the EU
-
6.3
Good pharmacovigilance practices
-
6.4
Periodic safety update reports
-
6.5
Benefit–risk assessment
-
6.6
Pharmacoepidemiological safety data
-
6.7
Product suspension and withdrawal and defective medicines
-
6.8
Safety signal
-
6.9
Spontaneous reporting
-
6.10
Post-authorization safety studies
-
6.11
Dear Healthcare Professional communication
-
6.12
Issues and crisis management
-
6.13
Adverse events in clinical trials
-
6.14
Risk management
-
6.1
Pharmacovigilance
-
Section 7 Healthcare marketplace
-
7.1
Marketing medicines: the drug lifecycle
-
7.2
The Foreign Corrupt Practices Act and UK Bribery Act
-
7.3
Product lifecycle management
-
7.4
Ethical marketing of medicines
-
7.5
The World Health Organization ethical criteria for medicinal drug promotion
-
7.6
Co-marketing and co-promotion
-
7.7
In-licensing
-
7.8
The Association of British Pharmaceutical Industries
-
7.9
The Association of British Pharmaceutical Industries Code of Practice
-
7.10
Pharmaceutical Research and Manufacturers of America
-
7.11
The International Federation of Pharmaceutical Manufacturers & Associations Code of Practice
-
7.12
The European Federation of Pharmaceutical Industries and Associations
-
7.13
Medicines Australia
-
7.14
National Institute for Health and Clinical Excellence
-
7.15
The Scottish Intercollegiate Guidelines Network
-
7.16
The Institute for Quality and Efficiency in Health Care
-
7.17
Health economics
-
7.18
Quality-adjusted life years
-
7.19
Pharmacoepidemiology
-
7.20
Branded generics
-
7.21
Intellectual property
-
7.22
Product liability and compensation
-
7.1
Marketing medicines: the drug lifecycle
-
Section 8 Therapeutics
-
End Matter
© Oxford University Press
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