Pharmaceutical Medicine

ISBN : 9780199609147

Adrian Kilcoyne; Phil Ambery; Daniel O'Connor
480 Pages
101 x 181 mm
Pub date
May 2013
Oxford Specialist Handbooks
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The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.


1.1 Intellectual Property in Discovery
1.2 Targeted drug discovery: Receptor based approaches
1.3 Invitro and invivo testing of new compounds
1.4 Lead optimisation
1.5 Natural Products and Herbal Medicines
2.1 General Principles of Medicines Regulation
2.2 Medicines Regulation in the UK
2.3 Medicines Regulation in EU
2.4 The European Medicines Agency and Heads of Medicine Agency
2.5 European Directorate for the Quality of Medicines and Healthcare, the European Pharmacopoeia and the British Pharmacopoeia
2.6 Food and Drug Administration
2.7 Health Canada
2.8 Medicines Regulation in Australia/NZ
2.9 Medicines Regulation in Japan
2.10 Medicines Regulation in China
2.11 Medical Devices Regulation
2.12 Clinical Trials Regulation
2.13 Good Clinical Practice
2.14 Good Laboratory Practice
2.15 Good Manufacturing Practice
2.16 Ethics Committee (European Union)
2.17 Institutional Review Board (US)
2.18 Marketing Authorisation Applications and updating and maintaining Licences
2.19 International Conference on Harmonisation
2.20 Common Technical Document
2.21 Medicinal Product Information in the EU
2.22 Summary of Product Characteristics
2.23 Orphan Drugs
2.24 Paediatric Investigational Plan
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 Drugs
2.30 Parallel imports
3.1 ADME
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 studies
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 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 CIOMS
3.22 Disease Models
3.23 Biomarkers
3.24 Pharmacogenetics
3.25 Population Pharmacokinetics
3.26 Small molecules and biologicals - safety / pharmacology requirements
4.1 Requirements for licensing and 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 Investigators Brochure
4.10 Organisation of project teams / project planning
4.11 Contractual arrangements with research sites and Contract Research Organisations
4.12 Case Report Form (CRF)
4.13 Budgeting and cost control
4.14 Expanded access programs
4.15 Study master file preparation
4.16 Target product profile
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 Minimising Bias
5.7 Paired and Unpaired t-test
5.8 Parametric and non parametric tests
5.9 Patient Reported Outcomes
5.10 Health Related Quality of life (HRQL)
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
6.1 Regulatory Requirements for Pharmacovigilance 6.1
6.2 Key pharmacovigilance regulations in the EU
6.3 Volume 9A
6.4 Periodic Safety Update Reports
6.5 Benefit Risk Assessment
6.6 Pharmacoepidemiological Safety Data
6.7 Product Suspension and Withdrawal & Defective Medicines
6.8 Safety Signal
6.9 Spontaneous Reporting
6.10 Post Authorisation Safety Studies (PASS)
6.11 Dear Healthcare Professional Communication
6.12 Issues and crisis management
6.13 Adverse Events in Clinical Trials
6.14 Risk Management
7.1 Marketing Medicines: The drug Lifecycle
7.2 FCPA and Bribery act
7.3 Product life cycle management
7.4 Ethical marketing of medicines
7.5 World Health Organisation (WHO) Ethical Criteria for Medicinal Drug Promotional
7.6 Co-marketing
7.7 Inlicensing
7.8 The Association of British Pharmaceutical Industries (ABPI)
7.9 The ABPI Code of Practice
7.10 PhRMA
7.11 IFPMA code of practice
7.12 The European Federation of Pharmaceutical Industries and Associations (EFPIA)
7.13 Medicines Australia
7.14 The National Institute for Health and Clinical Excellence (NICE)
7.15 The Scottish Intercollegiate Guidelines Network (SIGN)
7.16 IQWIG
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
8.1 Medicines for Children
8.2 Medicines in pregnancy
8.3 Medicines in the elderly
8.4 Medicines for patients with hepatic impairment
8.5 Medicines for patients with renal impairment
8.6 Principles of Risk Benefit
8.7 Therapeutic drug monitoring

About the author: 

Dr. Adrian Kilcoyne graduated from Trinity College Dublin in 1995. Following time as a Registrar in Reproductive Medicine in London, he spent some time as a Specialist Registrar in Public Health Medicine in Oxford followed by some years as a GP. He completed a Masters in Public Health at the London School of Hygiene and Tropical Medicine and a Masters in Business Administration at Warwick Business School. He joined the pharmaceutical industry in 2006 to become a Senior Clinical Research Physician in Diabetes at Eli Lilly. He has since held Medical Director positions at Baxter Healthcare and Roche and is now Medical Director at Sanofi Pasteur MSD, a dedicated vaccine company. Adrian has completed the Diploma in Pharmaceutical Medicine and is a Member of the Faculty of Pharmaceutical Medicine and has completed Higher medical Training in Pharmaceutical medicine. ; Dr. Daniel O'Connor is a Leicester medical graduate with a background in cancer research, histopathology and oncology. He joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a Medical Assessor in 2006 from a clinical lecturer post at UCL/UCH/Ludwig Institute for Cancer Research. He works in the licensing division of the MHRA, mainly reviewing oncology products and is also the UK representative on the Committee for Orphan Medicinal Products (COMP). He completed specialist training in Pharmaceutical Medicine in 2012. He is a fellow of the Foulkes Foundation.; Dr. Phil Ambery qualified in medicine from the University of Bristol in 1994. He undertook registrar training in the South-West of England and in Sydney, before returning to the UK in 2000 to study diabetes and endocrinology before leaving the NHS to work for GlaxoSmithKline. Since then he has held various posts in the GSK commercial organisation and latterly as a clinical program leader in the metabolic and cardiovascular pathways group at Glaxo. He is also an honorary clinical fellow at Addenbrooke's Hospital Cambridge, and a GMC specialist partner. He has a number of publications in the field of diabetes and cardiovascular medicine, and on the MRCP examination.

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