Pharmaceutical Medicine


The breadth of the pharmaceutical medicine curriculum can be daunting, but this book is designed to navigate a path through the chaos. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts in an accessible and user-friendly format. With 136 chapters spread across 8 sections, the text offers a thorough grounding in all aspects of the field, from regulatory control to trial-building and data management. This makes it a useful revision aid for exams as...

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Pharmaceutical Medicine

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The breadth of the pharmaceutical medicine curriculum can be daunting, but this book is designed to navigate a path through the chaos. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts in an accessible and user-friendly format. With 136 chapters spread across 8 sections, the text offers a thorough grounding in all aspects of the field, from regulatory control to trial-building and data management. This makes it a useful revision aid for exams as well as giving the reader a taster of areas of pharmaceutical medicine adjacent to their current role. For healthcare professionals already working in the field, the book offers a guiding hand in difficult situations as well as supplying access to the latest recommendations and guidelines. Comparing regulatory bodies and guidelines from around the world, it provides a truly global perspective that allows readers to confidently apply knowledge internationally. Produced in the style of the accessible Oxford Handbook series with plenty of space for notes, it details the facts in a concise and readable format, without the reader having to dive through page upon page of dense text. Written by authors with over 20 years of experience in the industry, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.

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Editorial Reviews

Doody's Review Service
Reviewer: Judith Klevan, BSPharm (Jeanes Hospital)
Description: With descriptions of the regulatory agencies, pharmacology, study analysis processes, drug safety, marketing, and therapeutics, this book details the overall drug development process.
Purpose: The authors intend this as a broad overview of all aspects of pharmaceutical medicine, a worthy goal as it is necessary for a diverse group of professionals to understand the drug development process.
Audience: The audience includes those working in the pharmaceutical industry or allied fields, those in formal training programs in pharmaceutical medicine, and other professionals involved in regulatory affairs, clinical research, or the marketing of medicines.
Features: This pocket-sized reference discusses the broad principles of the pharmaceutical manufacturing industry, such as drug discovery, regulatory agencies, medication regulation, clinical development of medications, statistics, drug safety, and healthcare marketing. It includes a limited number of tables, charts, and graphs, as well as an extensive list of abbreviations in the beginning of the book. It would benefit from more quick reference charts and tables; the font is small and hard to read. Overall, the presentation is dry.
Assessment: This would be a useful reference for those in the pharmaceutical manufacturing or drug company environment who need an update on various processes of development outside of their own department. There are no bibliography or reference sections, although there are suggestions for reading at the end of each chapter.
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Product Details

  • ISBN-13: 9780199609147
  • Publisher: Oxford University Press, USA
  • Publication date: 7/12/2013
  • Pages: 432
  • Product dimensions: 4.00 (w) x 7.00 (h) x 0.70 (d)

Meet 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.

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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Table of Contents

1. Therapeutic drug monitoring
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. Medicines Regulation
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. Clinical Pharmacology
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. Clinical Development
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. 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. 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. Drug Safety and Pharmacovigilance
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. Healthcare Marketplace
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. Therapeutics
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

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